search
Back to results

RSA vs RCR for Massive RCTs

Primary Purpose

Rotator Cuff Tears

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arthroscopy
Reverse Shoulder Arthroplasty
Sponsored by
La Tour Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1 Patient voluntarily consents to participate 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment 3 Patients with the following pre-operative images: Three standardized X-rays series and Magnetic Resonance Imaging (MRI) or arthro Magnetic Resonance Imaging without sign of traumatic lesions Exclusion Criteria: 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study 2 Revision rotator cuff repair 3 Patient consent withdrawal 4 Glenohumeral arthritis defined as stage > 3 Hamada classification 5 Infection and neuropathic joints 6 Known or suspected non-compliance, drug or alcohol abuse 7 Patients incapable of judgement or under tutelage 8 Inability to follow the procedures of the study 9 Enrolment of the investigator, his/her family members, employees and other dependent persons

Sites / Locations

  • Oregon Health & Science UniversityRecruiting
  • La Tour hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthroscopic surgery

Reverse shoulder arthroplasty

Arm Description

The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures.

The problems induced by the massive degenerative rotator cuff tear are solved by a complete replacement of the shoulder joint with a prosthesis (reverse design).

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Surgeon (ASES) score
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).

Secondary Outcome Measures

Pain on Visual Analogue Scale (pVAS)
Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst)
Constant score
From 0 (worst) to 100 (best)
Single Assessment Numeric Evaluation (SANE)
Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)
Complication
Any type of post-operative or intra-operative complication
Location of the defect
(at the foot print | medial cuff failure). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Signs of anchor displacement and location
(lateral | medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Signs of suture cut-through
(yes | no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Patient satisfaction
Licker scale comprising 7 points
Range of motion
Passive and active
Tendon defect
According to the Sugaya classification
Signs of stem or glenoid loosening
X-ray evaluation
Scapular notching
X-ray evaluation
Dislocation
X-ray evaluation
Acromial fracture
X-ray evaluation
Stem subsidence
X-ray evaluation

Full Information

First Posted
March 29, 2023
Last Updated
April 19, 2023
Sponsor
La Tour Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05807854
Brief Title
RSA vs RCR for Massive RCTs
Official Title
Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
La Tour Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).
Detailed Description
The majority of degenerative rotator cuff tears occur in individuals over 60 years of age. Therefore, as our population increases in size and advances in age, the incidence of rotator cuff tears is also increasing. A growing number of people are remaining active at this age, and continue to place substantial physical demands on their shoulders notably into their seventh and eighth decades of life. At the same time, the rotator cuff undergoes intrinsic degeneration and the prevalence of osteoporosis increases. Consequently, a significant and growing number of arthroscopic rotator cuff repairs are performed in individuals with poor soft tissue or bone quality. Moreover, whereas most rotator cuff tears occur at the tendon-bone insertion, fixation quality can be challenged by a tear that occurs more medially, leaving only a small amount of tendon for fixation by suture. Different treatment options are available for massive or irreparable rotator cuff tears, including debridement and subacromial decompression, repair (partial or complete), transfer of the subscapularis tendon, transfer of the teres major muscle, deltoid flap reconstruction, transfer of the latissimus dorsi or the pectoralis major, superior capsule reconstruction, augmented cuff repair, subacromial balloon and reverse total shoulder replacements. None of these treatments has proved superiority on other ones, particularly when the rotator cuff is massively torn. Massive degenerative rotator ruff tears are a challenge. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. Recently, Liu et al. demonstrated that both rotator cuff repair (RCR) and reverse shoulder arthroplasty (RSA) are effective and reliable options for massive rotator cuff tears (RCT), but revealed a better shoulder function for patients in the rotator cuff repair (RCR) group. While these results are interesting, this study remains retrospective and call for new studies with a higher level of evidence. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, Randomized Comparative Surgical Trial
Masking
None (Open Label)
Masking Description
The statistician will be blinded to patient allocation groups.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic surgery
Arm Type
Active Comparator
Arm Description
The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures.
Arm Title
Reverse shoulder arthroplasty
Arm Type
Experimental
Arm Description
The problems induced by the massive degenerative rotator cuff tear are solved by a complete replacement of the shoulder joint with a prosthesis (reverse design).
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy
Intervention Description
The surgeon reattaches the torn tendon to the bone with anchors and sutures.
Intervention Type
Device
Intervention Name(s)
Reverse Shoulder Arthroplasty
Intervention Description
It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeon (ASES) score
Description
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
Time Frame
At 24 post-operative months
Secondary Outcome Measure Information:
Title
Pain on Visual Analogue Scale (pVAS)
Description
Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst)
Time Frame
At 24 post-operative months
Title
Constant score
Description
From 0 (worst) to 100 (best)
Time Frame
At 24 post-operative months
Title
Single Assessment Numeric Evaluation (SANE)
Description
Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)
Time Frame
At 24 post-operative months
Title
Complication
Description
Any type of post-operative or intra-operative complication
Time Frame
Within the 24 post-operative months
Title
Location of the defect
Description
(at the foot print | medial cuff failure). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Time Frame
At 24 post-operative months
Title
Signs of anchor displacement and location
Description
(lateral | medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Time Frame
At 24 post-operative months
Title
Signs of suture cut-through
Description
(yes | no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Time Frame
At 24 post-operative months
Title
Patient satisfaction
Description
Licker scale comprising 7 points
Time Frame
At 24 post-operative months
Title
Range of motion
Description
Passive and active
Time Frame
At 24 post-operative months
Title
Tendon defect
Description
According to the Sugaya classification
Time Frame
At 24 post-operative months
Title
Signs of stem or glenoid loosening
Description
X-ray evaluation
Time Frame
At 24 post-operative months
Title
Scapular notching
Description
X-ray evaluation
Time Frame
At 24 post-operative months
Title
Dislocation
Description
X-ray evaluation
Time Frame
At 24 post-operative months
Title
Acromial fracture
Description
X-ray evaluation
Time Frame
At 24 post-operative months
Title
Stem subsidence
Description
X-ray evaluation
Time Frame
At 24 post-operative months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1 Patient voluntarily consents to participate 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment 3 Patients with the following pre-operative images: Three standardized X-rays series and Magnetic Resonance Imaging (MRI) or arthro Magnetic Resonance Imaging without sign of traumatic lesions Exclusion Criteria: 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study 2 Revision rotator cuff repair 3 Patient consent withdrawal 4 Glenohumeral arthritis defined as stage > 3 Hamada classification 5 Infection and neuropathic joints 6 Known or suspected non-compliance, drug or alcohol abuse 7 Patients incapable of judgement or under tutelage 8 Inability to follow the procedures of the study 9 Enrolment of the investigator, his/her family members, employees and other dependent persons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Lädermann, MD
Phone
+41 22 71 975 55
Email
alexandre.laedermann@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Lädermann, MD
Organizational Affiliation
La Tour hospital, Meyrin (1217) Geneva, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Denard, MD
Organizational Affiliation
Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Denard, MD
Facility Name
La Tour hospital
City
Meyrin
State/Province
Geneva
ZIP/Postal Code
1217
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Lädermann, MD
Phone
+41 22 719 75 55
Email
alexandre.laedermann@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Under reasonable request from scientists (with accepted research protocol)

Learn more about this trial

RSA vs RCR for Massive RCTs

We'll reach out to this number within 24 hrs