Prophylactic Conjoint Tendon Lengthening During Reverse Shoulder Arthroplasty Outcomes

NCT06729983 | Recruiting

• 1 other identifier: 218607
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Some patients may experience persistent pain in the front of their shoulder after reverse shoulder replacement. One of the possible reasons for this is that the surgery causes a change in the alignment of the shoulder joint, which may cause increased tension and compression on one of the biceps tendon called the conjoint tendon. The purpose of this study is to evaluate whether conjoint tendon lengthening, a surgical procedure that involves cutting and lengthening the conjoint tendon in order to reduce tension and compression, is able to prevent or reduce the risk of anterior shoulder pain at one year after surgery.

Conditions

Osteoarthritis Shoulder

Keywords

reverse shoulder athroplasty; conjoint tendon lengthening; pain outcome

Outcome Measures

Primary Outcomes (1)

• American Society of Shoulder and Elbow Surgeons (ASES) Score

  The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The higher the points the better the outcome.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (2)

• Visual Analog Scale (VAS) Pain Score

  From enrollment to the end of treatment at 12 months

• The Shoulder Pain and Disability Index (SPADI)

  From enrollment to end of treatment at 12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard reverse shoulder arthroplasty

Procedure: Standard Reverse Shoulder Arthroplasty

Treatment

EXPERIMENTAL

Prophylactic conjoint tendon lengthening in addition to reverse shoulder arthroplasty

Procedure: Prophylactic Conjoint Tendon Lengthening

Interventions

Prophylactic Conjoint Tendon Lengthening PROCEDURE

During a standard reverse shoulder arthroplasty procedure, the conjoint tendon will be incised and lengthened prophylactically

Treatment

Standard Reverse Shoulder Arthroplasty PROCEDURE

A standard reverse shoulder arthroplasty procedure will be performed

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are at least 18 years old undergoing primary reverse total shoulder arthroplasty
• Operations that occur at Loyola University Medical Center (Maywood, IL), Loyola Ambulatory Surgery Center (Maywood, IL), or Gottlieb Memorial Hospital

You may not qualify if:

• Patients younger than 18 years old
• Patients who had prior coracoid transfer procedure
• Patients who are undergoing revision surgery from a prior arthroplasty
• Current pregnancy As per standard protocol with all surgeries, a urine pregnancy test is performed prior to surgery. If positive, the surgery will be cancelled and the patient will be excluded from the research study.

Sponsors & Collaborators

• Nickolas Garbis: lead
• Loyola University School of Medicine: collaborator

Study Sites (1)

Loyola Outpatient Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (12)

• Werner BC, Chang B, Nguyen JT, Dines DM, Gulotta LV. What Change in American Shoulder and Elbow Surgeons Score Represents a Clinically Important Change After Shoulder Arthroplasty? Clin Orthop Relat Res. 2016 Dec;474(12):2672-2681. doi: 10.1007/s11999-016-4968-z. Epub 2016 Jul 8.

  PMID: 27392769 BACKGROUND

• Vij N, Tummala S, Shahriary E, Tokish J, Martin S. Total Shoulder Arthroplasty Versus Reverse Shoulder Arthroplasty in Primary Glenohumeral Osteoarthritis With Intact Rotator Cuffs: A Meta-Analyses. Cureus. 2024 Apr 8;16(4):e57866. doi: 10.7759/cureus.57866. eCollection 2024 Apr.

  PMID: 38725735 BACKGROUND

• Gomez GV, Huffman GR. Conjoint tendon lengthening for recalcitrant anterior shoulder pain after reverse shoulder arthroplasty: a technique article. JSES Rev Rep Tech. 2022 Jan 13;2(2):164-167. doi: 10.1016/j.xrrt.2021.12.005. eCollection 2022 May.

  PMID: 37587959 BACKGROUND

• Tashjian RZ, Frandsen JJ, Christensen GV, Chalmers PN. Conjoint tendon release for persistent anterior shoulder pain following reverse total shoulder arthroplasty. JSES Int. 2020 Jul 31;4(4):975-978. doi: 10.1016/j.jseint.2020.07.005. eCollection 2020 Dec.

  PMID: 33345243 BACKGROUND

• Boileau P, Melis B, Duperron D, Moineau G, Rumian AP, Han Y. Revision surgery of reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Oct;22(10):1359-70. doi: 10.1016/j.jse.2013.02.004. Epub 2013 May 22.

  PMID: 23706884 BACKGROUND

• Black EM, Roberts SM, Siegel E, Yannopoulos P, Higgins LD, Warner JJ. Failure after reverse total shoulder arthroplasty: what is the success of component revision? J Shoulder Elbow Surg. 2015 Dec;24(12):1908-14. doi: 10.1016/j.jse.2015.05.029. Epub 2015 Jul 7.

  PMID: 26163279 BACKGROUND

• Anakwenze OA, Kancherla VK, Carolan GF, Abboud J. Coracoid fracture after reverse total shoulder arthroplasty: a report of 2 cases. Am J Orthop (Belle Mead NJ). 2015 Nov;44(11):E469-72.

  PMID: 26566565 BACKGROUND

• Schwartz DG, Kang SH, Lynch TS, Edwards S, Nuber G, Zhang LQ, Saltzman M. The anterior deltoid's importance in reverse shoulder arthroplasty: a cadaveric biomechanical study. J Shoulder Elbow Surg. 2013 Mar;22(3):357-64. doi: 10.1016/j.jse.2012.02.002. Epub 2012 May 19.

  PMID: 22608931 BACKGROUND

• Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015 Jan;24(1):91-7. doi: 10.1016/j.jse.2014.08.026. Epub 2014 Oct 29.

  PMID: 25440519 BACKGROUND

• Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011 Dec 21;93(24):2249-54. doi: 10.2106/JBJS.J.01994.

  PMID: 22258770 BACKGROUND

• Grammont PM, Baulot E. The classic: Delta shoulder prosthesis for rotator cuff rupture. 1993. Clin Orthop Relat Res. 2011 Sep;469(9):2424. doi: 10.1007/s11999-011-1960-5. No abstract available.

  PMID: 21732025 BACKGROUND

• Drake GN, O'Connor DP, Edwards TB. Indications for reverse total shoulder arthroplasty in rotator cuff disease. Clin Orthop Relat Res. 2010 Jun;468(6):1526-33. doi: 10.1007/s11999-009-1188-9.

  PMID: 20049573 BACKGROUND

Study Officials

• Nickolas G Garbis, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nickolas G Garbis, MD

CONTACT

708-254-5312; ngarbis@lumc.edu

Dane H Salazar, MD, MBA

CONTACT

773-562-0456; dsalazar@lumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Shoulder/Elbow Division

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)