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SINEFIX-2022 Pilot Phase

Primary Purpose

Rotator Cuff Tears (RCTs)

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rotator cuff repair with the SINEFIX
Sponsored by
BAAT Medical Products B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears (RCTs)

Eligibility Criteria

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

Inclusion Criteria: Patient indicated for surgical repair of the rotator cuff tear according to current guidelines Patient aged 18 years or older Up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral) Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior) Exclusion Criteria: Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments Inflammatory arthropathies Subject with a contraindication/non-compliance for MRI examination Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule Pregnant and breastfeeding woman

Sites / Locations

  • Orthopädisch Chirurgisches Centrum (OCC)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SINEFIX

Arm Description

Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments

Outcomes

Primary Outcome Measures

Healing integrity
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Re-tear rate
Re-tear rate will be assessed with MRI
Dislocation of the implant
Presence of dislocation of the implant will be assessed with MRI (yes/no)
Bursitis
Presence of bursitis will be assessed with MRI (yes/no)

Secondary Outcome Measures

Surgery time
The total procedure duration will be recorded as the surgery time
Usability and workflow assessment
Usability and workflow assessment will be evaluated after each intervention through a practitioner's questionnaire covering different aspects of the implant and instruments
Functional and clinical outcome after rotator cuff repair
Functional and clinical outcome after rotator cuff repair will be assessed using the total Constant Murley score, which ranges from 0 (worst outcome) to 100 (best outcome)
Functional and clinical outcome after rotator cuff repair as compared with baseline
Functional and clinical outcome after rotator cuff repair will be assessed using the change of the total Constant Murley score (range 0-100) as compared to baseline
Shoulder function after rotator cuff repair (subjective evaluation)
Shoulder function after rotator cuff repair (subjective evaluation) will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome)
Shoulder function after rotator cuff repair (physical examination-active external rotation)
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active external rotation (range 0°-90°)
Shoulder function after rotator cuff repair (physical examination-active anteversion)
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active anteversion (0°-180°)
Healing integrity
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Re-tear rate
Re-tear rate will be assessed with MRI
Dislocation of the implant
Presence of dislocation will be assessed with MRI (yes/no)
Bursitis
Presence of bursitis will be assessed with MRI (yes/no)
Complications
Complications will be systematically reported. Complications of particular interest for the purpose of the study are neurological problems, bleeding, impaired wound healing, infection and frozen shoulder.
Patient satisfaction
The patient will be asked to rate his/her satisfaction with outcome of the surgical repair (0=completely unsatisfied, 1=unsatisfied, 2=satisfied, 3=completely satisfied)
Safety endpoint
Safety of the device will be evaluated by systematically reporting device deficiencies (DDs), adverse events (AEs) and serious adverse events (SAEs) and by monitoring the frequency and incidence of these events

Full Information

First Posted
January 17, 2023
Last Updated
September 14, 2023
Sponsor
BAAT Medical Products B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05721560
Brief Title
SINEFIX-2022 Pilot Phase
Official Title
Pre-market Clinical Investigation Inovedis SINEFIX
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BAAT Medical Products B.V.

4. Oversight

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

5. Study Description

Brief Summary
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full-thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended. Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs. For RCTs, treatment options include both surgical and non-surgical (conservative) procedures. In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears (RCTs)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot phase: single-arm prospective non-comparative single-centre study phase
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SINEFIX
Arm Type
Experimental
Arm Description
Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments
Intervention Type
Device
Intervention Name(s)
Rotator cuff repair with the SINEFIX
Intervention Description
Treatment of rotator cuff lesions of size up to 2 cm using the SINEFIX implant and instruments
Primary Outcome Measure Information:
Title
Healing integrity
Description
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Time Frame
3 months post operation
Title
Re-tear rate
Description
Re-tear rate will be assessed with MRI
Time Frame
3 months post operation
Title
Dislocation of the implant
Description
Presence of dislocation of the implant will be assessed with MRI (yes/no)
Time Frame
3 months post operation
Title
Bursitis
Description
Presence of bursitis will be assessed with MRI (yes/no)
Time Frame
3 months post operation
Secondary Outcome Measure Information:
Title
Surgery time
Description
The total procedure duration will be recorded as the surgery time
Time Frame
Immediately post procedure
Title
Usability and workflow assessment
Description
Usability and workflow assessment will be evaluated after each intervention through a practitioner's questionnaire covering different aspects of the implant and instruments
Time Frame
Immediately post procedure
Title
Functional and clinical outcome after rotator cuff repair
Description
Functional and clinical outcome after rotator cuff repair will be assessed using the total Constant Murley score, which ranges from 0 (worst outcome) to 100 (best outcome)
Time Frame
At 6 months, 1 and 2 years follow-up
Title
Functional and clinical outcome after rotator cuff repair as compared with baseline
Description
Functional and clinical outcome after rotator cuff repair will be assessed using the change of the total Constant Murley score (range 0-100) as compared to baseline
Time Frame
At 6 months, 1 and 2 years follow-up
Title
Shoulder function after rotator cuff repair (subjective evaluation)
Description
Shoulder function after rotator cuff repair (subjective evaluation) will be assessed through the Subjective Shoulder Value (SSV) which ranges from 0% to 100% (best outcome)
Time Frame
At 10 weeks, 6, 12, and 24 months
Title
Shoulder function after rotator cuff repair (physical examination-active external rotation)
Description
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active external rotation (range 0°-90°)
Time Frame
At 10 weeks, 6, 12, and 24 months
Title
Shoulder function after rotator cuff repair (physical examination-active anteversion)
Description
Shoulder function after rotator cuff repair (physical examination) will be assessed through a physical examination with assessment of range of motion for active anteversion (0°-180°)
Time Frame
At 10 weeks, 6, 12, and 24 months
Title
Healing integrity
Description
Healing integrity will be assessed with the MRI by evaluating the visibility of the tendon underneath the implant (yes/no)
Time Frame
At 6, 12, and 24 months
Title
Re-tear rate
Description
Re-tear rate will be assessed with MRI
Time Frame
At 6, 12, and 24 months
Title
Dislocation of the implant
Description
Presence of dislocation will be assessed with MRI (yes/no)
Time Frame
At 6, 12, and 24 months
Title
Bursitis
Description
Presence of bursitis will be assessed with MRI (yes/no)
Time Frame
At 6, 12, and 24 months
Title
Complications
Description
Complications will be systematically reported. Complications of particular interest for the purpose of the study are neurological problems, bleeding, impaired wound healing, infection and frozen shoulder.
Time Frame
During the follow up time (up to 24 months)
Title
Patient satisfaction
Description
The patient will be asked to rate his/her satisfaction with outcome of the surgical repair (0=completely unsatisfied, 1=unsatisfied, 2=satisfied, 3=completely satisfied)
Time Frame
At 10 weeks, 6, 12, 24 months
Title
Safety endpoint
Description
Safety of the device will be evaluated by systematically reporting device deficiencies (DDs), adverse events (AEs) and serious adverse events (SAEs) and by monitoring the frequency and incidence of these events
Time Frame
During the intervention and the follow up time (up to 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient indicated for surgical repair of the rotator cuff tear according to current guidelines Patient aged 18 years or older Up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral) Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior) Exclusion Criteria: Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments Inflammatory arthropathies Subject with a contraindication/non-compliance for MRI examination Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule Pregnant and breastfeeding woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tess van Dam, MSc
Phone
+31-(0)88-5656600
Email
tess@baatmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Kasten, Prof. Dr.
Phone
+49 (0) 7071 560 90
Email
kasten@occ-tuebingen.de
Facility Information:
Facility Name
Orthopädisch Chirurgisches Centrum (OCC)
City
Tübingen
ZIP/Postal Code
72074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Kasten, Prof. Dr.
Phone
+49 (0) 7071 560 90
Email
kasten@occ-tuebingen.de

12. IPD Sharing Statement

Plan to Share IPD
No

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SINEFIX-2022 Pilot Phase

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