Recruiting

Prophylactic Conjoint Tendon Lengthening

Sponsor:

Nickolas Garbis

Code:

NCT06729983

Conditions

Osteoarthritis Shoulder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prophylactic Conjoint Tendon Lengthening

Standard Reverse Shoulder Arthroplasty

Study Details

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

Study ID

NCT06729983

Start date

Mar, 2025

Status verified date

Mar, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

Standard reverse shoulder arthroplasty

experimental: Treatment

Prophylactic conjoint tendon lengthening in addition to reverse shoulder arthroplasty

Interventions

Prophylactic Conjoint Tendon Lengthening

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

Standard Reverse Shoulder Arthroplasty

A standard reverse shoulder arthroplasty procedure will be performed

Primary outcome measure

  • American Society of Shoulder and Elbow Surgeons (ASES) Score [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts and Locations

Central contacts

Nickolas G Garbis, MD

708-254-5312ngarbis@lumc.edu

Dane H Salazar, MD, MBA

773-562-0456dsalazar@lumc.edu

Locations

Loyola Outpatient Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Nickolas G Garbis, MD

708-254-5312ngarbis@lumc.edu

More Information

Sponsor

Nickolas Garbis

Last update posted

Mar 7, 2025

Last verified

Mar, 2025

Keywords

  • reverse shoulder athroplasty
  • conjoint tendon lengthening
  • pain outcome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nickolas Garbis on 2025-03-07.