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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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).
Oregon Health & Science University
Portland, Oregon, United States
RECRUITINGLa Tour hospital
Meyrin, Canton of Geneva, Switzerland
RECRUITINGAmerican Shoulder and Elbow Surgeon (ASES) score
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
Time frame: At 24 post-operative months
Pain on Visual Analogue Scale (pVAS)
Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst)
Time frame: At 24 post-operative months
Constant score
From 0 (worst) to 100 (best)
Time frame: At 24 post-operative months
Single Assessment Numeric Evaluation (SANE)
Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)
Time frame: At 24 post-operative months
Complication
Any type of post-operative or intra-operative complication
Time frame: Within the 24 post-operative months
Location of the defect
(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
Signs of anchor displacement and location
(lateral \| medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Time frame: At 24 post-operative months
Signs of suture cut-through
(yes \| no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Time frame: At 24 post-operative months
Patient satisfaction
Licker scale comprising 7 points
Time frame: At 24 post-operative months
Range of motion
Passive and active
Time frame: At 24 post-operative months
Tendon defect
According to the Sugaya classification
Time frame: At 24 post-operative months
Signs of stem or glenoid loosening
X-ray evaluation
Time frame: At 24 post-operative months
Scapular notching
X-ray evaluation
Time frame: At 24 post-operative months
Dislocation
X-ray evaluation
Time frame: At 24 post-operative months
Acromial fracture
X-ray evaluation
Time frame: At 24 post-operative months
Stem subsidence
X-ray evaluation
Time frame: At 24 post-operative months
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