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Procedure

Shoulder Replacement Techniques for Arthritis

N/A
Waitlist Available
Led By Young W Kwon, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is indicated for shoulder joint replacement
Be older than 18 years old
Must not have
Significant injury to the brachial plexus
Significant deformity of the proximal humerus that requires a custom made implant or where osteotomy of the shaft and / or the tuberosity has to be considered.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperatively
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the long-term outcomes of two different approaches to total shoulder replacement surgery.

Who is the study for?
This trial is for adults over 21 with arthritis needing shoulder replacement, who can survive at least 2 years post-surgery and commit to follow-up visits. It's not for those with prior shoulder replacements, brachial plexus injuries, inability to do long-term follow-ups, pregnant or lactating women, or significant shoulder deformities.
What is being tested?
The study compares two surgical techniques for total shoulder replacement: the traditional subscapularis release (TSR) and a newer rotator cuff sparing method. It aims to evaluate the long-term outcomes of each approach in patients randomized into two groups.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include pain at the surgery site, infection risk from surgery, possible damage to nearby nerves or blood vessels during operation, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am recommended to have a shoulder joint replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious injury to the nerves in my shoulder.
Select...
I need a custom implant for my upper arm bone due to its significant shape issue.
Select...
I have had joint replacement surgery in my affected shoulder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Outcome

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: TSR: rotator cuff sparingExperimental Treatment1 Intervention
Rotator cuff sparing technique TSR
Group II: TSR: traditional subscap releaseActive Control1 Intervention
TSR - traditional subscapularis release approach Subscapularis tendon release technique TSR

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,095 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,005 Patients Enrolled for Osteoarthritis
Young W Kwon, MD, PhDPrincipal InvestigatorNYU Hospital for Joint Diseases

Media Library

TSR - rotator cuff sparing (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01961986 — N/A
Osteoarthritis Research Study Groups: TSR: traditional subscap release, TSR: rotator cuff sparing
Osteoarthritis Clinical Trial 2023: TSR - rotator cuff sparing Highlights & Side Effects. Trial Name: NCT01961986 — N/A
TSR - rotator cuff sparing (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01961986 — N/A
~7 spots leftby Dec 2025
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