Shoulder Replacement Techniques for Arthritis
Trial Summary
What is the purpose of this trial?
Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder replacement (TSR).Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder replacement (TSR) is performed using the traditional surgical approach (called the subscapularis release approach) as compared to patients who have a TSR procedure done using a newer surgical approach (called the rotator cuff sparing approach).
Research Team
Young W Kwon, MD, PhD
Principal Investigator
NYU Hospital for Joint Diseases
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo total shoulder replacement (TSR) using either the traditional subscapularis release approach or the rotator cuff sparing approach
Follow-up
Participants are monitored for safety and effectiveness after treatment, including five office visits over two years with standard x-rays and self-administered questionnaires
Treatment Details
Interventions
- TSR - rotator cuff sparing
- TSR - traditional subscapularis release
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor