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/27392769Actively Recruiting
Led by Nickolas Garbis · Updated on 2025-03-07
110
Participants Needed
1
Research Sites
52 weeks
Total Duration
N
Nickolas Garbis
Lead Sponsor
L
Loyola University School of Medicine
Collaborating Sponsor
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
Prophylactic Conjoint Tendon Lengthening During Reverse Shoulder Arthroplasty Outcomes
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Loyola Outpatient Center
Maywood, Illinois, United States, 60153
Actively Recruiting
N
Nickolas G Garbis, MD
D
Dane H Salazar, MD, MBA
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Brian C Werner, Brenda Chang, Joseph T Nguyen...
https://pubmed.ncbi.nlm.nih.gov/27392769Neeraj Vij, Sailesh Tummala, Eahsan Shahriary...
https://pubmed.ncbi.nlm.nih.gov/38725735Gregory V Gomez, G Russell Huffman
https://pubmed.ncbi.nlm.nih.gov/37587959Robert Z Tashjian, Jeffrey J Frandsen, Garrett V Christensen...
https://pubmed.ncbi.nlm.nih.gov/33345243Pascal Boileau, Barbara Melis, David Duperron...
https://pubmed.ncbi.nlm.nih.gov/23706884Eric M Black, Susanne M Roberts, Elana Siegel...
https://pubmed.ncbi.nlm.nih.gov/26163279Oke A Anakwenze, Vamsi K Kancherla, Gregory F Carolan...
https://pubmed.ncbi.nlm.nih.gov/26566565Daniel G Schwartz, Sang Hoon Kang, T Sean Lynch...
https://pubmed.ncbi.nlm.nih.gov/22608931William W Schairer, Benedict U Nwachukwu, Stephen Lyman...
https://pubmed.ncbi.nlm.nih.gov/25440519Sunny H Kim, Barton L Wise, Yuqing Zhang...
https://pubmed.ncbi.nlm.nih.gov/22258770