Subscapularis Repair in Reverse Shoulder Arthroplasty

Rotator Cuff Tear Arthropathy Clinical Trial

— Subscap  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438914
• Other study ID #: AIRR-00608-20
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: September 14, 2025

Study information

• Verified date: January 2024
• Source: Arthrex, Inc.
• Contact: Kelly A Ganz
• Phone: 1 (800) 933-7001
• Email: kelly.ganz[@]arthrex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: September 14, 2025
• Est. primary completion date: September 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy

Intervention

Device:
• Repair of the subscapularis
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Locations

Country	Name	City	State
United States	The Campbell Clinic	Collierville	Tennessee
United States	Western Orthopaedics, P.C.	Denver	Colorado
United States	The Hawkins Foundation	Greenville	South Carolina
United States	Southern Oregon Orthopedics	Medford	Oregon
United States	Jordan Young Institute	Norfolk	Virginia
United States	The University of Arizona/Banner Health	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.