Pyrocarbon Hemiarthroplasty vs Total Shoulder Arthroplasty for Shoulder Arthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Narcotics, Corticosteroids

Disqualifiers: Rotator cuff tear, Drug abuse, others

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

Compensation: Varies

Number of Visits: 2

Duration: Surgical procedure with immediate postoperative care

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of shoulder surgery for individuals with shoulder arthritis. One group will undergo an anatomic total shoulder arthroplasty, which replaces the entire shoulder joint. The other group will receive a hemiarthroplasty with pyrocarbon, replacing only part of the joint with a special material. The researchers aim to determine which surgery provides better outcomes over the next ten years. The trial seeks participants with shoulder arthritis who are considered candidates for either surgery by their surgeon. Participants must speak English and agree to follow the study rules throughout its duration. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future treatment options for shoulder arthritis.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of consistent narcotic or chronic oral corticosteroid use, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hemiarthroplasty with pyrocarbon (HA-PYC) can be a reliable treatment for shoulder arthritis. It aids patients, particularly those under 60, in returning to work and sports. However, it carries a higher likelihood of requiring additional surgery later, approximately 7.6%, compared to other treatments.

For anatomic total shoulder arthroplasty (aTSA), studies indicate it has low rates of additional surgery in the short term and yields positive patient-reported outcomes, even for older individuals with arthritis. Patients often experience significant improvements in satisfaction and range of motion, which persist over time.

Both treatments are generally well-tolerated, but it is important to weigh the benefits and the potential for future surgeries when choosing an option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about hemiarthroplasty with pyrocarbon for shoulder arthritis because it introduces a new material—pyrocarbon—that is durable and biocompatible, meaning it works well with the body and lasts longer. Unlike standard treatments like metal and plastic implants used in total shoulder arthroplasty, pyrocarbon offers a smoother surface that mimics natural cartilage, potentially reducing wear and tear. This could mean less pain and longer-lasting results for patients.

What evidence suggests that this trial's treatments could be effective for shoulder arthritis?

This trial will compare Hemiarthroplasty with Pyrocarbon to Anatomic Total Shoulder Arthroplasty for shoulder arthritis. Studies have shown that a pyrocarbon implant in shoulder surgery can significantly enhance shoulder movement and overall outcomes. The implant is highly durable, with 92% remaining intact without replacement. Pyrocarbon also minimizes damage to the shoulder socket, promoting joint health.

Research indicates that anatomic total shoulder replacement surgery is effective for individuals with shoulder arthritis. It seldom requires further surgeries and receives positive feedback from patients. Many patients report significant improvements in shoulder function and express high satisfaction after this surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Benjamin Zmistowski, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with shoulder arthritis who meet specific health criteria. Participants will be randomly assigned to one of two treatment groups and followed for ten years to assess outcomes.

Inclusion Criteria

I am willing and able to follow the study rules and attend all required visits.

In good general health as evidenced by medical history

Fluent in English language

Exclusion Criteria

Presence of a glenoid that could not be reconstructed with the anatomic glenoid resurfacing components

Workers' compensation case

Known allergic reactions to components of the study product(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either hemiarthroplasty with pyrocarbon or anatomic total shoulder arthroplasty

Surgical procedure with immediate postoperative care

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinical and patient-reported outcome measures assessed

10 years

Regular follow-up visits at 2 weeks, 3 months, 6 months, 1 year, 2 years, 5 years, and 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Anatomic Total Shoulder Arthroplasty
• Hemiarthroplasty with Pyrocarbon

Trial Overview The study compares hemiarthroplasty using pyrocarbon (hPYC) against anatomic total shoulder arthroplasty (aTSA). It aims to determine which surgical method provides better postoperative results over a decade.

How Is the Trial Designed?

Group I: Anatomic total shoulder arthroplasty Active Control 1 Intervention

Group II: Hemiarthroplasty with pyrocarbon Active Control 1 Intervention

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666638325002981

Anatomical total shoulder arthroplasty for osteoarthritis in ... We found low short-term revision rates and good patient-reported outcomes for both older and middle-aged patients treated for osteoarthritis ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227341/

Promising short-term results after anatomical total shoulder ... There was an overall clinical improvement 2 years postoperatively. The aCS increased from 58.3 ± 17.7 to 113.7 ± 15.6 points (p < 0.0001). The ...

3. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746%2824%2900194-0/fulltext

an analysis of data from the National Joint Registry TSA resulted in superior OSSs at 6 months in patients with osteoarthritis. The median OSS improved from 6 months to 5 years following TSA; however, there was a ...

4. 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 ...

5. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/10/6/EOR-2025-0052.xml

Shoulder replacement in the under 55's is anatomical or ... ASA consistently emerges as the superior choice for younger patients with well-preserved rotator cuffs and minimal anatomical compromise.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10426543/

Outcomes of anatomic and reverse total shoulder arthroplasty ... Patient mortality was estimated to be 19.3% with a mean time to death of 6.1 years. Conclusions. Elderly patients with primary osteoarthritis and an intact ...

7. jsesinternational.org jsesinternational.org/article/S2666-6383(22)00104-9/fulltext

The recovery curve of anatomic total shoulder arthroplasty ... Patients undergoing anatomic TSA for primary GHOA showed excellent improvement in PROs and satisfaction in the first year, and these results were maintained ...

8. healio.com healio.com/news/orthopedics/20230921/total-shoulder-arthroplasty-deemed-safe-effective-for-patients-aged-80-years-and-older

Total shoulder arthroplasty deemed safe, effective for ... Researchers noted “satisfactory” range of motion outcomes as postoperative active forward flexion ranged from 138 to 150 after TSA and 83 to 139 ...