Subscapularis Repair in Reverse Shoulder Arthroplasty

Arthrex, Inc.134 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

134

Conditions

Rotator Cuff Tear Arthropathy

Interventions

Repair of the subscapularisDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (6)

The University of Arizona/Banner Health

Phoenix, Arizona, United States

RECRUITING

Western Orthopaedics, P.C.

Denver, Colorado, United States

NOT_YET_RECRUITING

Southern Oregon Orthopedics

Medford, Oregon, United States

Outcomes

Primary Outcomes

Constant-Murley Shoulder Outcome Score

A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.

Time frame: Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.

Constant-Murley Shoulder Outcome Score

Time frame: Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.

Constant-Murley Shoulder Outcome Score

Time frame: Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.

Constant-Murley Shoulder Outcome Score

Time frame: Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure.

Constant-Murley Shoulder Outcome Score

Central Contacts

Kelly A Ganz

CONTACT

1 (800) 933-7001 kelly.ganz@arthrex.com

Samantha Martino

CONTACT

1 (800) 933-7001 samantha.martino@arthrex.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Ultrasound

Evaluation of the subscapularis complex in patients that have been randomized to "repair of the subscapularis" to examine the subscapularis complex. Ultrasound scans will be read and the integrity of the subscapularis complex will be determined by the clinician to be "intact", "attenuated", "partial tear" or "complete tear".

Time frame: Collected once at either the 6 month, 1 year or 2 year timepoint.

American Shoulder and Elbow Surgeons (ASES) subjective survey

A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient.