Shoulder Replacement Techniques for Arthritis

Recruiting in Palo Alto (17 mi)

Overseen byYoung W Kwon, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

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

I am recommended to have a shoulder joint replacement.

I am willing to follow all visit requirements before and after surgery.

I am 21 years old or older.

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Exclusion Criteria

I need a custom implant for my upper arm bone due to its significant shape issue.

I have a serious injury to the nerves in my shoulder.

Inability or unwillingness to participate in the post operative evaluation for the entire 24 months period.

See 3 more

Treatment Details

Interventions

TSR - rotator cuff sparing (Procedure)
TSR - traditional subscapularis release (Procedure)

Trial OverviewThe 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.

Participant Groups

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