search
Back to results

Subscap Reverse Shoulder Arthroplasty

Primary Purpose

Shoulder Injuries, Rotator Cuff Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subscap Tenotomy
Subscap Repair
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subscap Tenotomy

Subscap Repair

Arm Description

Outcomes

Primary Outcome Measures

Change in Internal Rotation
Internal rotation behind the back
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 6, 2022
Last Updated
March 27, 2023
Sponsor
University of Maryland, Baltimore
search

1. Study Identification

Unique Protocol Identification Number
NCT05344898
Brief Title
Subscap Reverse Shoulder Arthroplasty
Official Title
Subscapularis Repair in Reverse Shoulder Arthroplasty: A Multi-Center Randomized Single Blinded Superiority Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 15, 2027 (Anticipated)
Study Completion Date
May 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries, Rotator Cuff Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subscap Tenotomy
Arm Type
Experimental
Arm Title
Subscap Repair
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Subscap Tenotomy
Intervention Description
Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.
Intervention Type
Procedure
Intervention Name(s)
Subscap Repair
Intervention Description
Group will have their subscapularis tendon repaired following a reverse shoulder replacement.
Primary Outcome Measure Information:
Title
Change in Internal Rotation
Description
Internal rotation behind the back
Time Frame
Pre-op and post-op Months 3,6,12,24
Title
Change in BOSS Scores
Description
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.
Time Frame
Pre-op and post-op Months 3,6,12,24
Secondary Outcome Measure Information:
Title
Change in ASES score
Description
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.
Time Frame
Pre-op and post-op Months 3,6,12,24
Other Pre-specified Outcome Measures:
Title
Ultrasound Evaluation
Description
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
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohit Gilotra, MD
Phone
3015024102
Email
mgilotra@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Gilotra, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohit N Gilotra, M.D./M.S.
Phone
301-502-4102
Email
MGilotra@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Kevin K Wendeu-Foyet, B.S
Phone
301-978-1431
Email
kevinwendeufoyet@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28034540
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.
Results Reference
background
PubMed Identifier
28277259
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.
Results Reference
background
PubMed Identifier
26796602
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.
Results Reference
background
PubMed Identifier
27751722
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.
Results Reference
background
PubMed Identifier
28162886
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.
Results Reference
background
PubMed Identifier
27566617
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.
Results Reference
background
PubMed Identifier
28005111
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.
Results Reference
background
PubMed Identifier
2281232
Citation
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.
Results Reference
background
PubMed Identifier
23268518
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.
Results Reference
background

Learn more about this trial

Subscap Reverse Shoulder Arthroplasty

We'll reach out to this number within 24 hrs