TerminatedNo phase
Rotator Cuff Sparing Total Arthroplasty
Key facts
- Who runs it
- NYU Langone Health
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 108 people enrolled
- Started
- Jul 2010
- Ended
- 12 Aug 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TSR - traditional subscapularis release
- TSR - rotator cuff sparing
- Record updated
- 13 November 2026
- Why it stopped
- Terminated because sufficient data has been collected to do analysis and a manuscript has been published.
Who can take part
- Age
- 21 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Patient is indicated for shoulder joint replacement
- Patient is at least 21 years of age
- Patient is expected to survive at least 2 years beyond surgery
- Patient is willing to participate by complying with pre-and post-operative visit requirements
- Patient is willing and able to review and sign a study informed consent form
Who cannot take part
- Prior arthroplasty in the affected shoulder
- 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
- Significant medial erosion of the glenoid such that lateral edge of the humeral head lies medial to the lateral rim of the acromion
- Significant injury to the brachial plexus
- Inability or unwillingness to participate in the post operative evaluation for the entire 24 months period
- Pregnant and lactating women will be excluded
Where in United States
- NYU Hospital for Joint DiseasesNew York, United StatesNo longer taking part
About the trial
What the trial wants to find out
Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder replacement (TSR).
Read full original descriptionShow less
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).
The 2 groups in the trial
- TSR: traditional subscap releaseExisting treatment, for comparison
TSR - traditional subscapularis release approach Subscapularis tendon release technique TSR
Treatment: TSR - traditional subscapularis release
- TSR: rotator cuff sparingTreatment being tested
Rotator cuff sparing technique TSR
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Rotator Cuff Sparing Total Arthroplasty - A Prospective, Randomized Clinical Trial
- Record updated
- 13 November 2026