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Tendon Lengthening for Shoulder Arthritis

Maywood, IL
N/A
Recruiting
Led By Nickolas G Garbis, MD
Research Sponsored by Nickolas Garbis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are at least 18 years old undergoing primary reverse total shoulder arthroplasty
Be older than 18 years old
Must not have
Patients who had prior coracoid transfer procedure
Patients who are undergoing revision surgery from a prior arthroplasty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment at 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a surgery called conjoint tendon lengthening, which involves cutting and lengthening a tendon in the shoulder, can help reduce or prevent persistent pain in the front of the shoulder

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Who is the study for?
This trial is for individuals with shoulder osteoarthritis who are planning to undergo reverse shoulder replacement surgery. It aims to see if lengthening the conjoint tendon can prevent pain after surgery. Participants should not have other conditions that could affect their recovery.Check my eligibility
What is being tested?
The study compares standard reverse shoulder arthroplasty with a version that includes prophylactic conjoint tendon lengthening, to determine if the latter reduces post-surgical anterior shoulder pain at one year.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection and bleeding, along with specific complications from tendon lengthening like altered muscle function or weakness in the arm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and having a specific shoulder replacement surgery.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a coracoid transfer surgery before.
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I am having surgery to revise a previous joint replacement.
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I am under 18 years old.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of treatment at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of treatment at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
American Society of Shoulder and Elbow Surgeons (ASES) Score
Secondary study objectives
The Shoulder Pain and Disability Index (SPADI)
Visual Analog Scale (VAS) Pain Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Prophylactic conjoint tendon lengthening in addition to reverse shoulder arthroplasty
Group II: ControlActive Control1 Intervention
Standard reverse shoulder arthroplasty

Find a Location

Closest Location:Loyola Outpatient Center· Maywood, IL· 286 miles
Image of Loyola Outpatient Center in Maywood, United States.Image of Loyola Outpatient Center in Maywood, United States.Image of Loyola Outpatient Center in Maywood, United States.

Who is running the clinical trial?

Loyola University School of MedicineUNKNOWN
1 Previous Clinical Trials
1,296 Total Patients Enrolled
Nickolas GarbisLead Sponsor
Nickolas G Garbis, MDPrincipal InvestigatorLoyola University
~73 spots leftby Mar 2028
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