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Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room? (NANOBICEPS)

Primary Purpose

Shoulder Pain, Biceps Tendon Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hyperambulatory tenotomy
Operating room tenotomy
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient over 18 years-old,
  • With shoulder pain associated to massive irreparable rotator cuff and a biceps still presents (premature Hamada's stages, 1 to 3); Or with an isolated pathology of biceps with intact rotator cuff (in particular bicipital instability, subluxation, tenosynovitis, pre-rupture)
  • Indication for tenotomy according orthopedic surgeon
  • having given written consent after written and oral information,
  • member of the social security system.

Exclusion Criteria:

  • patient protected by law or under guardianship r curatorship, or not able to participae in a clinical trial under L.1121-16 article of French Public Health Regulations
  • pregnant or nursing patient,
  • Allergies to local anesthetics
  • Athletes
  • Capsulitis in progress
  • history of shoulder surgery
  • Medical history of infection
  • fracture of proximal end of the humerus
  • Patient refusal to take part

Sites / Locations

  • CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyperambulatory tenotomy

Operating room tenotomy

Arm Description

regarding randomization result, patient wil have a tenotomy of biceps' long head by mini-optics in consultation

regarding randomization result, patient wil have a tenotomy of biceps' long head upon arthroscopy under normal operating condition

Outcomes

Primary Outcome Measures

Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.

Secondary Outcome Measures

Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Number of scare will be visually evaluated by investigators
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Number of scare will be visually evaluated by investigators
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Number of scare will be visually evaluated by investigators
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Number of scare will be visually evaluated by investigators
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Number of scare will be visually evaluated by investigators
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Time to onset will be evaluated by investigator, in number of days.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Time to onset will be evaluated by investigator, in number of days.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Time to onset will be evaluated by investigator, in number of days.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Time to onset will be evaluated by investigator, in number of days.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Time to onset will be evaluated by investigator, in number of days.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.

Full Information

First Posted
April 29, 2022
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05370183
Brief Title
Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
Acronym
NANOBICEPS
Official Title
Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
May 29, 2025 (Anticipated)
Study Completion Date
May 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Mini-optics has been used in orthopedics for a short time. The Nanoscope used in this study is marketed by Arthrex. Its main indications concern knee, elbow, wrist, carp and small joints of long fingers for diagnostic and sometimes therapeutic purposes. Some teams use it to replace expensive radiological examinations and/or difficult to access, in consultation, for diagnostic in the knee, but also for therapeutic for partial meniscectomy with several related publications. The investigators recently published a feasibility study of isolated tenotomy of the biceps with this minimally invasive device in consultation (first indexed article describing this technique). This project is part of the broader context of "In Office" surgery, for which there are many applications. Through the miniaturisation of optics and access to "portable" technologies, surgical procedures can now be performed in consultation ("In Office"). For example: release of the carpal tunnel or ulnar canal to the elbow under ultrasound, partial meniscectomy, removal of foreign body from the elbow in consultation. Indeed, in addition to the technical interest of this innovation for a simple and frequent surgical procedure, it should make it possible to transpose anxiety management for the patient, time-consuming and costly for the institution into a heavy technical platform (operating room) towards a simplified, fast and streamlined approach in consultation. In the scientific literature, other equivalent surgical procedures have already been identified and performed in consultation with various tools (carpal tunnel, ulnar nerve in the elbow, meniscectomy in the knee but also in other surgical specialties such as cataract in ophthalmology) with better patient satisfaction, improved patient journey, reduced costs, an increase in the number of patients treated. The investigators wish to demonstrate the non-inferiority of intraarticular tenotomy of the biceps long head performed in consultation with mini-optics and local anaesthesia compared to the operating room in order to modify practices and optimize the management of patients within the institution while improving their satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Biceps Tendon Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperambulatory tenotomy
Arm Type
Experimental
Arm Description
regarding randomization result, patient wil have a tenotomy of biceps' long head by mini-optics in consultation
Arm Title
Operating room tenotomy
Arm Type
Active Comparator
Arm Description
regarding randomization result, patient wil have a tenotomy of biceps' long head upon arthroscopy under normal operating condition
Intervention Type
Procedure
Intervention Name(s)
Hyperambulatory tenotomy
Intervention Description
Using mini-optics a minimally invasive device, hypermabulatory tenotomy is performed in consultation, with a local anethesia
Intervention Type
Procedure
Intervention Name(s)
Operating room tenotomy
Intervention Description
Operating room tenotomy is performed according standard practice, with general anesthesia.
Primary Outcome Measure Information:
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
At inclusion (V0)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
3 hours after surgery (V1)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
The day after surgery (V2)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
2 weeks after surgery (V3)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
6 weeks after surgery (V4)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
3 months after surgery (V5)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
6 months after surgery (V6)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on pain felt by patient
Description
Pain felt will be assessed with a visual and analog scale for pain. The scale ranges from 0 (no pain) to 10 (maximum thinkable pain). Limit of non-inferiority is fixed to 1.5 on this scale.
Time Frame
12 months after surgery (V7)
Secondary Outcome Measure Information:
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Description
Number of scare will be visually evaluated by investigators
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Description
Number of scare will be visually evaluated by investigators
Time Frame
6 weeks (V4) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Description
Number of scare will be visually evaluated by investigators
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Description
Number of scare will be visually evaluated by investigators
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on number of scare
Description
Number of scare will be visually evaluated by investigators
Time Frame
12 months (V7) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Description
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Description
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Time Frame
6 weeks after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Description
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Description
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's length
Description
Scare's length will be assessed by investigator with a small ruler, in millimeter.
Time Frame
12 months (V7) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Description
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Description
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Time Frame
6 weeks (V4) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Description
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Description
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on scare's width
Description
Scare's width will be assessed by investigator with a small ruler, in millimeter.
Time Frame
12 months (V7) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Description
Time to onset will be evaluated by investigator, in number of days.
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Description
Time to onset will be evaluated by investigator, in number of days.
Time Frame
6 weeks (V4) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Description
Time to onset will be evaluated by investigator, in number of days.
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Description
Time to onset will be evaluated by investigator, in number of days.
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality, in particular on time to onset
Description
Time to onset will be evaluated by investigator, in number of days.
Time Frame
12 months (V7) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Description
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Description
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Time Frame
6 weeks (V4) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Description
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Description
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on scare quality,in particular on possible desunion
Description
Desunion will be evaluated by investigator, with 2 possible values : yes or no.
Time Frame
12 months (V7) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Description
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Time Frame
At inclusion (V0)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Description
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Description
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Time Frame
6 weeks (V4) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Description
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Description
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on active and passive mobility
Description
Active and passive mobility of both shoulders will be assessed by investigator on following parameters: abduction, adduction, flexion extension, internal and external rotation. All theses paramèters will be assessed with a goniometer, in degree.
Time Frame
12 months (V7) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
Description
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Time Frame
At inclusion (V0)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
Description
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
Description
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Time Frame
6 weeks (V4) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
Description
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
Description
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on shoulder function, in particular on Subjective Shoulder Value
Description
The Subjective Shoulder Value will be evalued by patient himself, by answering the following question: What value do you give to your shoulder, out of 100, compared to a normal shoulder rated at 100% ? this scale ranges from 0 (non-functional shoulder) to 100 (normal shoulder)
Time Frame
12 months (V7) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Description
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Time Frame
At inclusion (V0)
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Description
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Time Frame
2 weeks (V3) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Description
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Time Frame
6 weeks (V4) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Description
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Time Frame
3 months (V5) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Description
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Time Frame
6 months (V6) after surgery
Title
Demonstrate the non-inferiority of tenotomy of biceps' long head by mini-optics in consultation (hyperambulatory) compared to upon arthroscopy under normal operating condition on patient satisfaction, with Constant's score
Description
Patient satisfaction will be evaluated using Constant's score, a quantitative value from 0 to 100.
Time Frame
12 months (V7) after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient over 18 years-old, With shoulder pain associated to massive irreparable rotator cuff and a biceps still presents (premature Hamada's stages, 1 to 3); Or with an isolated pathology of biceps with intact rotator cuff (in particular bicipital instability, subluxation, tenosynovitis, pre-rupture) Indication for tenotomy according orthopedic surgeon having given written consent after written and oral information, member of the social security system. Exclusion Criteria: patient protected by law or under guardianship r curatorship, or not able to participae in a clinical trial under L.1121-16 article of French Public Health Regulations pregnant or nursing patient, Allergies to local anesthetics Athletes Capsulitis in progress history of shoulder surgery Medical history of infection fracture of proximal end of the humerus Patient refusal to take part
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc-Olivier GAUCI
Phone
04 92 03 69 04
Ext
+33
Email
gauci.mo@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc-Olivier GAUCI
Phone
04 92 03 69 04
Email
gauci.mo@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Marc-Olivier GAUCI

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?

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