Subscap Reverse Shoulder Arthroplasty

Rotator Cuff Injuries Clinical Trial

Official title:

Subscapularis Repair in Reverse Shoulder Arthroplasty: A Multi-Center Randomized Single Blinded Superiority Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344898
• Other study ID #: HP-00100825
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: May 15, 2027

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Mohit Gilotra, MD
• Phone: 3015024102
• Email: mgilotra[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.

Description:

You're going to undergo a procedure called a reverse shoulder replacement and I'm sure Dr. Gilotra already went over the procedure with you but I will again briefly. Before the hardware is put in, there is a tendon in your shoulder that has to be "released". It's released because the doctor has to move it out of the way to get to your shoulder joint. Now when the hardware has been implanted and the surgery is complete, the doctor now has two options. He can decide to repair this tendon or not. The thing is due to the hardware that is implanted, your shoulder doesn't really need this tendon anymore to help it move. So, there are some doctors in the country who choose to repair the tendon and there are some doctors who choose to just let it be. Patients have done great with either or. We are performing this nationwide study to see if one option (between repairing this tendon or leaving it) is slightly better than the other. There is a chance that repairing the tendon can decrease the risk of dislocations in the future and also help you move your arm better. There is a chance that this repair doesn't matter at all. If we figure out whether to repair or not to repair this tendon, we will be able to better define complications, potentially decrease surgery time, and improve how well patients perform daily activities. We randomize you to the repair on don't repair group, almost like flipping a coin. With me, you'll be answering simple questions that will track your functionality over time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: May 15, 2027
• Est. primary completion date: May 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

1. 18 to 95 years old

2. Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Exclusion Criteria:

1. Irreparable Subscapularis Tendon a. Reparability of Subscapularis will be determined based on MRI or CT scan obtained preoperatively and confirmed intraoperatively. Tendons must be intact with less than Grade I or II Fatty Infiltration as determined by the Goutallier classification.

2. Any history of proximal humerus fracture

3. Any revision with proximal humerus bone loss

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Injuries
• Wounds and Injuries

Intervention

Procedure:
• Subscap Tenotomy
Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.
• Subscap Repair
Group will have their subscapularis tendon repaired following a reverse shoulder replacement.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (9)

Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990 Dec;9(12):1447-54. doi: 10.1002/sim.4780091208. — View Citation

Friedman RJ, Flurin PH, Wright TW, Zuckerman JD, Roche CP. Comparison of reverse total shoulder arthroplasty outcomes with and without subscapularis repair. J Shoulder Elbow Surg. 2017 Apr;26(4):662-668. doi: 10.1016/j.jse.2016.09.027. Epub 2016 Oct 27. — View Citation

Kohan EM, Chalmers PN, Salazar D, Keener JD, Yamaguchi K, Chamberlain AM. Dislocation following reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Jul;26(7):1238-1245. doi: 10.1016/j.jse.2016.12.073. Epub 2017 Feb 3. — View Citation

Otto RJ, Clark RE, Frankle MA. Reverse shoulder arthroplasty in patients younger than 55 years: 2- to 12-year follow-up. J Shoulder Elbow Surg. 2017 May;26(5):792-797. doi: 10.1016/j.jse.2016.09.051. Epub 2016 Dec 26. — View Citation

Padegimas EM, Zmistowski BM, Restrepo C, Abboud JA, Lazarus MD, Ramsey ML, Williams GR, Namdari S. Instability After Reverse Total Shoulder Arthroplasty: Which Patients Dislocate? Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):E444-E450. — View Citation

Pastor MF, Kraemer M, Wellmann M, Hurschler C, Smith T. Anterior stability of the reverse shoulder arthroplasty depending on implant configuration and rotator cuff condition. Arch Orthop Trauma Surg. 2016 Nov;136(11):1513-1519. doi: 10.1007/s00402-016-2560-3. Epub 2016 Aug 26. — View Citation

Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802. — View Citation

Villacis D, Sivasundaram L, Pannell WC, Heckmann N, Omid R, Hatch GF 3rd. Complication rate and implant survival for reverse shoulder arthroplasty versus total shoulder arthroplasty: results during the initial 2 years. J Shoulder Elbow Surg. 2016 Jun;25(6):927-35. doi: 10.1016/j.jse.2015.10.012. Epub 2016 Jan 18. — View Citation

Vourazeris JD, Wright TW, Struk AM, King JJ, Farmer KW. Primary reverse total shoulder arthroplasty outcomes in patients with subscapularis repair versus tenotomy. J Shoulder Elbow Surg. 2017 Mar;26(3):450-457. doi: 10.1016/j.jse.2016.09.017. Epub 2016 Oct 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasound Evaluation	Blinded ultrasound evaluation of subscapularis integrity at 6 months. The "Sugaya classification" will be used to assess the subscapularis integrity. The score ranges from Type 1 to Type 5.; Type 1: indicating sufficient thickness with homogeneously low intensity; Type 2: sufficient thickness with partial high intensity; Type 3: insufficient thickness without discontinuity; Type 4: the presence of a minor discontinuity; Type 5: the presence of a major discontinuity	Month 6
Primary	Change in Internal Rotation	Internal rotation behind the back	Pre-op and post-op Months 3,6,12,24
Primary	Change in BOSS Scores	Change in Baltimore Orthopaedic Subscapularis Score (BOSS) over 2 years. The score asks enrolled patients a series of questions. The answer choices are the following: No difficulty, mild difficulty, severe difficulty, unable to perform.	Pre-op and post-op Months 3,6,12,24
Secondary	Change in ASES score	Change in American Shoulder and Elbow Surgeon (ASES) score over 2 years postoperatively compared to preoperative. The score ranges from 0 to 10 with 0 indicating no pain and 10 indicating worst pain possible.	Pre-op and post-op Months 3,6,12,24