RSA vs RCR for Massive RCTs

Rotator Cuff Tears Clinical Trial

Official title:

Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807854
• Other study ID #: 2023-00111
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2023
• Source: La Tour Hospital
• Contact: Alexandre Lädermann, MD
• Phone: +41 22 71 975 55
• Email: alexandre.laedermann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Arthroscopy
The surgeon reattaches the torn tendon to the bone with anchors and sutures.

Device:
• Reverse Shoulder Arthroplasty
It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

Locations

Country	Name	City	State
Switzerland	La Tour hospital	Meyrin	Geneva
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
La Tour Hospital

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Surgeon (ASES) score	American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).	At 24 post-operative months
Secondary	Pain on Visual Analogue Scale (pVAS)	Pain on Visual Analogue Scale (pVAS). From 0 (best) to 10 (worst)	At 24 post-operative months
Secondary	Constant score	From 0 (worst) to 100 (best)	At 24 post-operative months
Secondary	Single Assessment Numeric Evaluation (SANE)	Single Assessment Numeric Evaluation (SANE). From 0 (worst) to best (100)	At 24 post-operative months
Secondary	Complication	Any type of post-operative or intra-operative complication	Within the 24 post-operative months
Secondary	Location of the defect	(at the foot print | medial cuff failure). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.	At 24 post-operative months
Secondary	Signs of anchor displacement and location	(lateral | medial row). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.	At 24 post-operative months
Secondary	Signs of suture cut-through	(yes | no). Radiographic outcome evaluated using an ultrasound examination. Only for the Arthroscopic group.	At 24 post-operative months
Secondary	Patient satisfaction	Licker scale comprising 7 points	At 24 post-operative months
Secondary	Range of motion	Passive and active	At 24 post-operative months
Secondary	Tendon defect	According to the Sugaya classification	At 24 post-operative months
Secondary	Signs of stem or glenoid loosening	X-ray evaluation	At 24 post-operative months
Secondary	Scapular notching	X-ray evaluation	At 24 post-operative months
Secondary	Dislocation	X-ray evaluation	At 24 post-operative months
Secondary	Acromial fracture	X-ray evaluation	At 24 post-operative months
Secondary	Stem subsidence	X-ray evaluation	At 24 post-operative months