Subscapularis Repair in Reverse Shoulder Arthroplasty (Subscap)

Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study

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

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear Arthropathy
• Intervention / Treatment: Device: Repair of the subscapularis

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.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly A Ganz; Phone Number: 71119 1 (800) 933-7001; Email: kelly.ganz@arthrex.com
• Study Contact Backup: Name: Samantha Martino; Phone Number: 71970 1 (800) 933-7001; Email: samantha.martino@arthrex.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • The University of Arizona/Banner Health
      • Contact: Saleh Ahmed
  • Colorado
    • Denver, Colorado, United States, 80218
      • Not yet recruiting
      • Western Orthopaedics, P.C.
      • Contact: Mallory Boyd; Email: mboyd@western-ortho.com
      • Principal Investigator: Benjamin Sears, MD
  • Oregon
    • Medford, Oregon, United States, 97504
      • Recruiting
      • Southern Oregon Orthopedics
      • Contact: Patrick Denard, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • The Hawkins Foundation
      • Principal Investigator: Michael Kissenberth, MD
      • Contact: Sam Pergiovanni; Phone Number: 888-666-2904
  • Tennessee
    • Collierville, Tennessee, United States, 38017
      • Recruiting
      • The Campbell Clinic
      • Contact: Margaret Knack
  • Virginia
    • Norfolk, Virginia, United States, 23462
      • Recruiting
      • Jordan Young Institute
      • Contact: Amanda Firoved

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reverse Shoulder Arthroplasty with subscapularis repair; The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.	Device: Repair of the subscapularis; The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
No Intervention: Reverse Shoulder Arthroplasty without subscapularis repair; The subscapularis will not be repaired.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.
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.	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	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.	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	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.	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	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.	Collected at the 2 year post-op timepoint, and is the primary outcome measure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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.	Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Simple Shoulder Test (SST) questionnaire	Provides a standardized way of recording the function of a shoulder before and after treatment.	Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Visual Analog Scale (VAS)	The standard measure for pain on a 0-10 scale, 10 being the worst.	Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)	A patient administrated questionnaire for measurement of the quality of life. It provides scores on four domains: 1.) physical symptoms, 2.) sport, recreation, and work, 3.) lifestyle and 4.) emotions.	Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Veterans Rand 12 Item Health Survey (VR-12)	A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status.	Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Single Assessment Numeric Evaluation score (SANE)	Asks patients to rate shoulder pain as a percentage of normal.	Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Standard Pre-Operative Form	A patient administered form that asks patients to evaluate their expectations of their scheduled Arthroplasty procedure.	Collected at the pre-op visit.
Return to Work Form	A patient administered form that asks patients to determine the effect that their shoulder has had on their employment.	Collected at pre-op, 26 weeks and 1 year.
Standard Late Postoperative Form	A patient administered form that asks patient to evaluate if their expectations were met regarding their Arthroplasty procedure.	Collected at the 1 year and 2 year timepoints.

Collaborators and Investigators

• Sponsor: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Estimated): September 14, 2025
• Study Completion (Estimated): September 14, 2025

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Crystal Arthropathies; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: AIRR-00608-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No