Aptis PRUJ Prosthesis for Arthritis

Recruiting at 5 trial locations

Overseen By Stacy Gardner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aptis Medical

Must not be taking: Corticosteroids, NSAIDs

Disqualifiers: Severe arthritis, Infection, High BMI, 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 post-operative care

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Aptis PRUJ Prosthesis, a joint replacement device designed to help those with severe elbow joint problems, specifically where the radius and ulna bones meet. The goal is to determine if this prosthesis can safely and effectively reduce pain and improve movement in individuals with painful and unstable elbow joints due to injuries or wear and tear. Individuals experiencing ongoing pain and difficulty moving their elbows, who can follow post-surgery instructions, might be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to medical research and potentially benefit from an innovative treatment.

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

The trial does not specify if you need to stop taking your current medications, but it excludes patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Aptis PRUJ Prosthesis is safe for treating proximal radial ulna joint disorders?

Research has shown that the Aptis PRUJ prosthesis is generally safe for treating joint problems. Studies have found it effective, especially when other surgeries have failed. Many patients have experienced good results with this treatment. However, some complications have been reported. In one study, about 64% of patients encountered issues, and around 41% required additional surgery later.

While the device has a success rate of 92%, awareness of these potential risks is important. The treatment has also been used successfully for a similar condition, providing some reassurance about its safety. Discussing the risks and benefits with a healthcare provider is crucial before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Aptis PRUJ Prosthesis is unique because it offers a new approach to treating arthritis in the proximal radioulnar joint by providing a specialized implant designed to replace the damaged joint. Unlike standard treatments that often focus on pain management and mobility through medications or joint fusion surgeries, this prosthesis aims to restore joint function and improve range of motion by directly addressing the structural issues. Researchers are excited about this treatment because it has the potential to offer patients a more durable and long-lasting solution with improved joint mechanics, which could significantly enhance their quality of life compared to existing options.

What evidence suggests that the Aptis PRUJ Prosthesis is effective for proximal radial ulna joint disorders?

Research has shown that the Aptis PRUJ Prosthesis, which participants in this trial will receive, can reduce pain and improve arm and hand function for those with joint problems. One study found that patients experienced less pain and better arm function after receiving the prosthesis. Another study showed that the implant lasted well, with 92% still functioning effectively, although some patients required additional surgeries. Overall, these findings suggest the prosthesis effectively treats issues in the elbow joint. ^{2 3 5 6 7}

Who Is on the Research Team?

John Scheker

Principal Investigator

Aptis Medical

Are You a Good Fit for This Trial?

This trial is for adults under 85 with painful, unstable radial heads due to degeneration or injury, causing pain and limited motion in the elbow joints. Participants must understand and agree to the study's requirements including post-op rehab.

Inclusion Criteria

Patients willing and able to understand and sign the informed consent. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the post-operative rehabilitation and follow-up visits per protocol.

I am over 18 and under 85 years old.

I have pain and limited movement in my elbow due to injury or wear and tear.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Aptis PRUJ Prosthesis for the treatment of proximal radial ulna joint disorders

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Annual visits until 2-year post-operative time point

Extended Follow-up

Annual visits continue until the last patient reaches the 2-year post-operative time point

Up to 36 months total study duration

What Are the Treatments Tested in This Trial?

Interventions

• Aptis PRUJ Prosthesis

Trial Overview The safety and effectiveness of the Aptis PRUJ Prosthesis are being tested on patients with disorders of the proximal radial ulna joint. This single-arm study will monitor how well this prosthesis improves joint function.

How Is the Trial Designed?

Group I: Aptis PRUJ Prothesis Experimental Treatment 1 Intervention

Investigational Aptis PRUJ Prothesis treatment

Who Is Running the Clinical Trial?

Aptis Medical

Lead Sponsor

Trials

1

Recruited

80+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10543792/

Retrospective and Prospective Outcomes of Distal ... Our study has shown positive outcomes with decrease in pain, improvement in function via Disabilities of the Arm, Shoulder, and Hand evaluation, and subjective ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05796908

Aptis PRUJ Prosthesis for the Treatment of Patients With ... This is a prospective, multi-center, single-arm clinical trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/17531934231192375

Long-term results of the Aptis TM total distal radioulnar joint ... We present a prospective study with the results of ten Aptis total distal radioulnar joint replacements in patients who had one to five previous operations.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0974322725000699

Combined semi-constrained total distal radioulnar joint ... Semi-constrained total distal radioulnar joint (DRUJ) arthroplasty with Aptis-Scheker implant has demonstrated excellent results in patients with end-stage ...

5. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0043-1774317

Aptis Distal Radioulnar Joint Arthroplasty - Thieme Connect Results Implant survival was 92%, the surgical follow-up showed many complications (64,4%), and revision surgery was needed frequently (40.7%). In 13 cases, the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10520165/

The semiconstrained DRUJ prosthesis: blessing or curse? The semiconstrained Aptis-prosthesis is a safe and efficient treatment option after failed DRUJ surgeries. It is striking that of the 20 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26075895/

[Outcome After Implantation of the Aptis Total Distal ... Conclusion: The Aptis prosthesis is a safe and efficient treatment option for previously failed surgery of the DRUJ. © Georg Thieme Verlag KG Stuttgart · New ...