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Recruiting NCT05344898

Subscap Reverse Shoulder Arthroplasty

No phase Interventional Shoulder Injuries Rotator Cuff Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Subscap Tenotomy, Subscap Repair.
Who it may be relevant to
Registry conditions: Shoulder Injuries, Rotator Cuff Injuries. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Change in Internal Rotation [Time frame: Pre-op and post-op Months 3,6,12,24]
  • Change in BOSS Scores [Time frame: Pre-op and post-op Months 3,6,12,24]
Secondary outcome measures (1)
  • Change in ASES score [Time frame: Pre-op and post-op Months 3,6,12,24]

Eligibility criteria

Inclusion criteria

  • 18 to 95 years old
  • Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Exclusion criteria

  • 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.

  • Any history of proximal humerus fracture
  • Any revision with proximal humerus bone loss

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Maryland School of Medicine — Baltimore

Publications

  • 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. PMID 28034540
  • 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. PMID 28277259
  • 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. PMID 26796602
  • 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. PMID 27751722
  • 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. PMID 28162886
  • 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. PMID 27566617
  • 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. PMID 28005111
  • 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. PMID 2281232

Identifiers

NCT: NCT05344898 · HP-00100825

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗