Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06729983

Prophylactic Conjoint Tendon Lengthening During Reverse Shoulder Arthroplasty to Reduce Anterior Shoulder Pain at One Year

Led by Nickolas Garbis · Updated on 2025-03-07

110

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

N

Nickolas Garbis

Lead Sponsor

L

Loyola University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether prophylactic conjoint tendon lengthening (CTL) during reverse shoulder arthroplasty (RSA) can prevent or reduce anterior shoulder pain one year after surgery. RSA is a surgical treatment for severe shoulder arthritis with rotator cuff damage that reverses the ball and socket of the shoulder joint to improve function and pain. Some patients experience persistent front shoulder pain after RSA, possibly due to increased tension on the conjoint tendon, and this study will investigate if CTL can address this issue. Participants will be randomly assigned to one of two groups: one receiving standard RSA and the other receiving RSA combined with CTL, where the conjoint tendon is incised and lengthened during surgery to reduce tension. The study will compare outcomes at 6 and 12 months after surgery between these groups, assessing pain intensity, shoulder motion, strength, activity levels, and patient-reported results. The trial will also explore factors that may predict how well patients respond to CTL. During the study, participants will undergo regular assessments including the American Society of Shoulder and Elbow Surgeons (ASES) score at 12 months as the primary outcome. Secondary measures include the Visual Analog Scale (VAS) for pain and the Shoulder Pain and Disability Index (SPADI). Participants will be monitored through these evaluations to understand the impact of the surgical procedures on their shoulder pain and function over the course of one year.

CONDITIONS

Brief Title

Prophylactic Conjoint Tendon Lengthening During Reverse Shoulder Arthroplasty Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are at least 18 years old undergoing primary reverse total shoulder arthroplasty
  • Operations that occur at Loyola University Medical Center, Loyola Ambulatory Surgery Center, or Gottlieb Memorial Hospital
Not Eligible

You will not qualify if you...

  • 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 confirmed by urine pregnancy test prior to surgery

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day to several days

Participants undergo reverse shoulder arthroplasty surgery, with or without prophylactic conjoint tendon lengthening, followed by immediate recovery in the hospital.

1 surgical visit and immediate post-operative hospital stay

Post-operative Follow-up

Duration - 12 months

Participants are monitored for recovery, pain levels, shoulder function, and any complications following surgery.

Visits at 6 months and 12 months post-surgery

Trial Site Locations

Total: 1 location

1

Loyola Outpatient Center

Maywood, Illinois, United States, 60153

Actively Recruiting

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Research Team

N

Nickolas G Garbis, MD

D

Dane H Salazar, MD, MBA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

What Change in American Shoulder and Elbow Surgeons Score Represents a Clinically Important Change After Shoulder Arthroplasty?

Brian C Werner, Brenda Chang, Joseph T Nguyen...

https://pubmed.ncbi.nlm.nih.gov/27392769

Total Shoulder Arthroplasty Versus Reverse Shoulder Arthroplasty in Primary Glenohumeral Osteoarthritis With Intact Rotator Cuffs: A Meta-Analyses.

Neeraj Vij, Sailesh Tummala, Eahsan Shahriary...

https://pubmed.ncbi.nlm.nih.gov/38725735

Conjoint tendon release for persistent anterior shoulder pain following reverse total shoulder arthroplasty.

Robert Z Tashjian, Jeffrey J Frandsen, Garrett V Christensen...

https://pubmed.ncbi.nlm.nih.gov/33345243