Shoulder Replacement Techniques for Arthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Prior shoulder arthroplasty, Significant humerus deformity, Significant glenoid erosion, Brachial plexus injury, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Surgery and immediate recovery

108 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total shoulder replacement (TSR) using either the traditional subscapularis release approach or the rotator cuff sparing approach

Surgery and immediate recovery

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

2 years

5 visits (in-person)

Treatment Details

Interventions

• TSR - rotator cuff sparing
• TSR - traditional subscapularis release

Trial Overview 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.

Participant Groups

Group I: TSR: rotator cuff sparing Experimental Treatment 1 Intervention

Rotator cuff sparing technique TSR

Group II: TSR: traditional subscap release Active Control 1 Intervention

TSR - traditional subscapularis release approach Subscapularis tendon release technique TSR

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+