Rotator Cuff Tears
Conditions
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).
Interventions
PROCEDUREArthroscopy
The surgeon reattaches the torn tendon to the bone with anchors and sutures.
It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).
Sponsors
La Tour Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The statistician will be blinded to patient allocation groups.
Intervention model description
Multicenter, Randomized Comparative Surgical Trial
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeon (ASES) score | At 24 post-operative months | American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant score | At 24 post-operative months | From 0 (worst) to 100 (best) |
| Single Assessment Numeric Evaluation (SANE) | At 24 post-operative months | Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100) |
| Complication | Within the 24 post-operative months | Any type of post-operative or intra-operative complication |
| Location of the defect | At 24 post-operative months | (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 | At 24 post-operative months | (lateral \| medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group. |
| Signs of suture cut-through | At 24 post-operative months | (yes \| no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group. |
| Patient satisfaction | At 24 post-operative months | Licker scale comprising 7 points |
| Pain on Visual Analogue Scale (pVAS) | At 24 post-operative months | Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst) |
| Tendon defect | At 24 post-operative months | According to the Sugaya classification |
| Signs of stem or glenoid loosening | At 24 post-operative months | X-ray evaluation |
| Scapular notching | At 24 post-operative months | X-ray evaluation |
| Dislocation | At 24 post-operative months | X-ray evaluation |
| Acromial fracture | At 24 post-operative months | X-ray evaluation |
| Stem subsidence | At 24 post-operative months | X-ray evaluation |
| Range of motion | At 24 post-operative months | Passive and active |
Countries
Switzerland, United States
Contacts
Primary ContactAlexandre Lädermann, MD
Outcome results
None listed