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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two surgical methods for total shoulder replacement (TSR) in patients with arthritis. One method uses the traditional subscapularis release approach, while the other spares the rotator cuff, a group of muscles and tendons that help move the shoulder. Researchers seek to determine which technique provides better long-term outcomes. Individuals needing shoulder joint replacement and able to commit to follow-up visits for two years might be suitable candidates for this study. As an unphased trial, this study allows patients to contribute to valuable research that could enhance surgical techniques for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these shoulder replacement techniques are safe?

Research shows that both surgical methods for total shoulder replacement (TSR) are generally safe for patients. The TSR using the rotator cuff sparing technique successfully reduces pain and improves movement for people with arthritis, making it a popular choice.

For the traditional subscapularis release method, reviews indicate it is also safe and effective. Studies show no major differences in results between different ways of handling the subscapularis muscle, so the traditional method is well-accepted by patients.

In summary, both the newer rotator cuff sparing and the traditional subscapularis release methods are considered safe. They effectively help patients regain movement and reduce pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing different shoulder replacement techniques for arthritis because it investigates innovative surgical methods. The rotator cuff sparing technique is distinctive because it aims to preserve more of the shoulder's natural structure, potentially leading to quicker recovery and less post-surgical pain compared to traditional methods. On the other hand, the traditional subscapularis release approach, while more conventional, is a well-established method known for its reliability. By comparing these two approaches, the trial hopes to determine which method offers better outcomes in terms of function and recovery, potentially improving the quality of life for arthritis patients.

What evidence suggests that these shoulder replacement techniques are effective for arthritis?

This trial will compare two shoulder replacement techniques for arthritis. Research has shown that the traditional subscapularis release method, one of the techniques under study, can significantly improve shoulder movement and function for up to two years. Studies indicate this method has a 10.3% chance of requiring further surgery or treatment, suggesting it is a reliable option for treating shoulder arthritis.

In contrast, the rotator cuff sparing method, another technique in this trial, is a newer approach that preserves the rotator cuff, potentially leading to fewer complications and better shoulder function. Long-term evidence suggests that 88% of patients do not need additional surgery for at least ten years with this approach. Both methods offer promising results for patients needing total shoulder replacement due to arthritis. ^{6 7 8 9 10}

Who Is on the Research Team?

Young W Kwon, MD, PhD

Principal Investigator

NYU Hospital for Joint Diseases

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12039979/

Long-Term Outcomes Following Reverse Total Shoulder ... RTSA can provide satisfactory improvement of pain and function at long-term follow-up mean revision-free survivorship of 88% after 10 years.

2. bmj.com bmj.com/content/385/bmj-2023-077939

Reverse total shoulder replacement versus anatomical ... This study's findings provide reassurance that RTSR is an acceptable alternative to TSR for patients aged 60 years or older with osteoarthritis and intact ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32315453/

Shoulder replacement surgery for osteoarthritis and rotator ... The rate of any adverse event following stemmed humeral hemiarthroplasty was 286 per 1000, and following conventional stemmed TSR 143 per 1000, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324001658

Glenohumeral osteoarthritis and reverse shoulder ... RTSA is an effective treatment for GHOA with an intact rotator cuff resulting in highly favorable patient-reported outcomes that are comparable to those of aTSA ...

5. 2minutemedicine.com 2minutemedicine.com/reverse-total-shoulder-replacement-may-be-a-viable-treatment-option-for-shoulder-osteoarthritis/

Reverse total shoulder replacement may be a viable ... 1. Reverse total shoulder replacement (RTSR) was examined as a potential treatment for end-stage shoulder arthritis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7173708/

Shoulder replacement surgery for osteoarthritis and rotator ... Although it is an established procedure, no high‐quality randomised trials have been conducted to determine whether shoulder replacement might be more effective ...

7. clinicaltrial.be clinicaltrial.be/en/details/12194?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Rotator Cuff Sparing Total Arthroplasty For patients with arthritis, TSR can successfully improve pain and restore function. As a result, TSR has become the treatment of choice for ...

8. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2436/rotator-cuff-sparing-total/

Rotator cuff sparing total shoulder arthroplasty - Clinical Trials The purpose of this study is to collect and evaluate long-term clinical data on patients whose total shoulder replacement (TSR) is performed using the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043097/

Optimizing Outcomes After Reverse Total Shoulder ... This review synthesizes the current literature regarding the impact of post-operative immobilization and rehabilitation on clinical outcomes following RTSA ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2214963517301141

Shoulder arthroplasty—Past, present and future Males, younger age (<75 years), previous shoulder surgery, reverse TSR, rotator cuff arthropathy and inpatient TSR increased shoulder PJI risk. For TER ...