Catalyst CSR Shoulder System for Shoulder Osteoarthritis

Recruiting at 2 trial locations

Overseen By Robin Waite, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Catalyst OrthoScience

Disqualifiers: Osteoporosis, Neuromuscular disorders, Infections, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: Perioperative

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study conducted in the United States.

Will I have to stop taking my current medications?

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.

How is the Catalyst CSR Shoulder System treatment different from other treatments for shoulder osteoarthritis?

The Catalyst CSR Shoulder System is a unique treatment for shoulder osteoarthritis as it involves a specific type of shoulder replacement that may offer benefits in terms of anatomical fit and function, particularly for younger, active patients. Unlike traditional shoulder replacements, it may focus on preserving more of the patient's natural bone and joint structure, potentially leading to better outcomes for those wishing to maintain an active lifestyle. ^{1 2 3 4 5}

Research Team

J. Michael Wiater, MD

Principal Investigator

Beaumont Hospital Royal Oak

Eligibility Criteria

This trial is for adults with degenerative shoulder conditions like arthritis or necrosis who need a hemi or total shoulder arthroplasty. Candidates must be skeletally mature and fit the device's usage guidelines. Exclusions include chronic joint issues, high risk of implant failure due to weight/activity, non-compliance with care instructions, neuromuscular disorders affecting joint control, metal allergies, metabolic diseases affecting implants' longevity, osteoporosis, certain prior surgeries or rotator cuff tears.

Inclusion Criteria

Meets the Catalyst CSR Shoulder System Indications for Use according to approved labeling

I have a mature skeleton with shoulder joint disease needing surgery.

I am 18 years old or older.

Exclusion Criteria

In the opinion of the investigator, it is not in the patient's best interest to participate in this study

I am unable or unwilling to follow post-surgery care instructions.

I have a condition that affects my ability to control my joints.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of the Catalyst CSR Shoulder System in skeletally mature patients with degenerative disease of the glenohumeral joint

Perioperative

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for safety and effectiveness with clinical and radiographic assessments at multiple time points

24 months

4 visits (in-person) at 3, 6, 12, and 24 months

Long-term Follow-up

Continued monitoring for adverse events and patient-reported outcomes

12 months

Treatment Details

Interventions

• Catalyst CSR Shoulder System

Trial Overview The Catalyst CSR Shoulder System is being tested in this study to assess its performance and safety through clinical and radiographic evaluations over a period of up to 24 months post-surgery. This prospective multi-center study will take place across various locations in the United States.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Intervention with a 510k cleared shoulder arthroplasty device

Catalyst CSR Shoulder System is already approved in United States for the following indications:

Approved in United States as Catalyst CSR Shoulder System for:

• Osteoarthritis
• Avascular Necrosis of the Head of Humerus
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity

Who Is Running the Clinical Trial?

Catalyst OrthoScience

Lead Sponsor

Trials

1

Recruited

90+

Findings from Research

The UNIVERS 3-D prosthesis significantly improved shoulder function in 74 patients with glenohumeral osteoarthritis, with Constant scores increasing from 34.1 to 68.4 points after an average follow-up of 31.9 months.

The procedure demonstrated a low complication rate of 12.2% and a minimal incidence of radiolucent lines around the prosthesis, indicating both safety and efficacy in reconstructing shoulder anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical outcomes of treatment of glenohumeral osteoarthritis with new generation shoulder prosthesis]. Tang, KL., Li, QH., Habermeyer, P.[2016]

In a study of 33 shoulders in 27 patients with primary osteoarthritis, cementless stemless resurfacing arthroplasty (CSRA) demonstrated good clinical outcomes, with a mean Constant-Murley score of 56.4 and low pain levels reported during activities (NRS 3.8).

However, the radiological outcomes were concerning, with high rates of oversizing (54.5%) and glenoid erosion (45.5%), indicating that while the procedure is clinically effective, it may have significant structural issues that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiological results 7 years after Copeland shoulder resurfacing arthroplasty in patients with primary glenohumeral osteoarthritis: an independent multicentre retrospective study. Verstraelen, FU., Horta, LA., Schotanus, MGM., et al.[2018]

Total shoulder replacement (TSR) showed significantly less pain than hemiarthroplasty (HA) at 6 months, 1 year, and 2 years post-surgery, with 42% of TSR patients reporting pain-free shoulders at the 10-year mark, while no HA patients reported being pain-free.

At the 10-year follow-up, there were no significant differences in pain, function, or daily activities between the two groups, but TSR had a lower revision rate compared to HA, indicating better long-term outcomes for TSR despite some complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemiarthroplasty vs total shoulder replacement for rotator cuff intact osteoarthritis: how do they fare after a decade? Sandow, MJ., David, H., Bentall, SJ.[2022]

Cementless surface replacement arthroplasty (CSRA) shows good long-term results for treating glenohumeral arthritis in young patients under 50, with 81.6% of patients experiencing significant improvement in function and high satisfaction scores (8.7 out of 10) after an average follow-up of 14.5 years.

Despite the positive outcomes, 18.5% of shoulders required revision surgery, indicating that while CSRA is effective, there is a notable risk of complications that may necessitate further procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surface replacement arthroplasty for glenohumeral arthropathy in patients aged younger than fifty years: results after a minimum ten-year follow-up. Levy, O., Tsvieli, O., Merchant, J., et al.[2018]

Shoulder arthroplasty is increasingly recommended for younger, active individuals with glenohumeral osteoarthritis when nonsurgical treatments fail, offering options like hemiarthroplasty and total shoulder arthroplasty.

Surgeons must understand the evolution of these techniques and practical guidelines to help patients effectively return to sports after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoulder Arthroplasty in the Aging Athlete: Considerations in the Younger Patient. Bolia, IK., Bell, JA., Cole, BJ., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical outcomes of treatment of glenohumeral osteoarthritis with new generation shoulder prosthesis]. [2016]

2. France pubmed.ncbi.nlm.nih.gov

Clinical and radiological results 7 years after Copeland shoulder resurfacing arthroplasty in patients with primary glenohumeral osteoarthritis: an independent multicentre retrospective study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Hemiarthroplasty vs total shoulder replacement for rotator cuff intact osteoarthritis: how do they fare after a decade? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Surface replacement arthroplasty for glenohumeral arthropathy in patients aged younger than fifty years: results after a minimum ten-year follow-up. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Shoulder Arthroplasty in the Aging Athlete: Considerations in the Younger Patient. [2022]