Arthroscopy
ProcedureThe surgeon reattaches the torn tendon to the bone with anchors and sutures.
NCT Number: NCT05807854
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).
Interested in participating?
Request Info60 year–80 year
All sexes
Interventional
Not applicable
La Tour hospital, Meyrin, Canton of Geneva, Switzerland
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: At 24 post-operative months
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). From 0 (best) to 10 (worst)
Time frame: At 24 post-operative months
From 0 (worst) to 100 (best)
Time frame: At 24 post-operative months
Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)
Time frame: Within the 24 post-operative months
Any type of post-operative or intra-operative complication
Time frame: At 24 post-operative months
(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
(lateral | medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Time frame: At 24 post-operative months
(yes | no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.
Time frame: At 24 post-operative months
Licker scale comprising 7 points
Time frame: At 24 post-operative months
Passive and active
Time frame: At 24 post-operative months
According to the Sugaya classification
Time frame: At 24 post-operative months
X-ray evaluation
Time frame: At 24 post-operative months
X-ray evaluation
Time frame: At 24 post-operative months
X-ray evaluation
Time frame: At 24 post-operative months
X-ray evaluation
Time frame: At 24 post-operative months
X-ray evaluation
Contact information is provided by the study sponsor or research team.
La Tour Hospital
Other
Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial
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