Subscapularis Repair in Reverse Shoulder Arthroplasty

Arthrex

Status: Enrolling

Conditions: Rotator Cuff Tear Arthropathy

Treatments: Device: Repair of the subscapularis

Study type: Interventional

Funder types: Industry

Identifiers

NCT05438914

AIRR-00608-20

Details and patient eligibility

About

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

Full description

The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative.

Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
2. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
3. Patient meets FDA cleared indications for reverse shoulder arthroplasty
4. Patient is between 18-100 years old
5. Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
6. Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning

Exclusion criteria

1. Patient has a history of ipsilateral shoulder arthroplasty
2. A history of shoulder septic arthritis
3. A full thickness subscapularis tear
4. An acute or malunited proximal humeral fracture
5. Chronic locked dislocation
6. Rheumatoid arthritis
7. Tumors
8. Axillary nerve damage
9. Non-functioning deltoid muscle
10. Glenoid vault deficiency precluding baseplate fixation
11. Infection and neuropathic joints
12. Known or suspected non-compliance, drug or alcohol abuse
13. Patients incapable of judgement or under tutelage
14. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
15. The subject is related to investigator as family members, employees, or other dependent persons
16. Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Reverse Shoulder Arthroplasty with subscapularis repair

Experimental group

Description:

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Treatment:

Device: Repair of the subscapularis

Reverse Shoulder Arthroplasty without subscapularis repair

No Intervention group

Description:

The subscapularis will not be repaired.