Clinical trial NCT05438914: Subscapularis Repair in Reverse Shoulder Arthroplasty
Official title: Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly allocated in a 1:1 ratio, with block sizes of four and six using a randomization sequence.
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Constant-Murley Shoulder Outcome Score
timeFrame: Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.
measure: Constant-Murley Shoulder Outcome Score
timeFrame: Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
measure: Constant-Murley Shoulder Outcome Score
timeFrame: Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
measure: Constant-Murley Shoulder Outcome Score
timeFrame: Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
measure: Constant-Murley Shoulder Outcome Score
timeFrame: Collected at the 2 year post-op timepoint, and is the primary outcome measure
Secondary outcomes:
measure: Ultrasound
timeFrame: Collected once at either the 6 month, 1 year or 2 year timepoint.
measure: American Shoulder and Elbow Surgeons (ASES) subjective survey
timeFrame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
measure: Simple Shoulder Test (SST) questionnaire
timeFrame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
measure: Visual Analog Scale (VAS)
timeFrame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
measure: Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
timeFrame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
measure: Veterans Rand 12 Item Health Survey (VR-12)
timeFrame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
measure: Single Assessment Numeric Evaluation score (SANE)
timeFrame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
measure: Standard Pre-Operative Form
timeFrame: Collected at the pre-op visit.
measure: Return to Work Form
timeFrame: Collected at pre-op, 26 weeks and 1 year.
measure: Standard Late Postoperative Form
timeFrame: Collected at the 1 year and 2 year timepoints.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The University of Arizona/Banner Health
state: Arizona
city: Denver
country: United States
facility: Western Orthopaedics, P.C.
state: Colorado
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
city: Greenville
country: United States
facility: The Hawkins Foundation
state: South Carolina
city: Collierville
country: United States
facility: The Campbell Clinic
state: Tennessee
city: Norfolk
country: United States
facility: Jordan Young Institute
state: Virginia
Study officials:
References: