Atlas Knee System for Osteoarthritis

(Atlas-USA Trial)

No longer recruiting at 8 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of the Atlas Knee System for individuals with medial knee osteoarthritis, a type of arthritis affecting the inner knee. The focus is on evaluating how well this device reduces pain and improves knee function over two years post-surgery. This trial may suit those experiencing knee pain primarily on the inside, worsened by activities like walking, and who have not found relief from treatments such as physical therapy or pain medication. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on medications that affect bone metabolism or systemic steroids, you may need to discuss this with the trial team.

What prior data suggests that the Atlas Knee System is safe for medial knee osteoarthritis?

Research has shown that the Atlas Knee System is generally well-tolerated by patients with medial knee osteoarthritis. One study found the device to be safe over three years, with 97.3% of the implants functioning well without needing removal or replacement. Another study reported that 96.2% of patients experienced significant pain relief, indicating that the device not only reduces pain but is also safe for most users. Patients noted improvements in daily activities and overall knee function.

While these results are promising, individual experiences may vary. It is important to consult a doctor before joining a clinical trial to understand the potential risks and benefits.12345

Why are researchers excited about this trial?

The Atlas Knee System is unique because it directly targets medial knee osteoarthritis using a specialized device, rather than standard treatments like pain medication or physical therapy. Unlike surgical options such as total knee replacement, the Atlas Knee System offers a less invasive alternative, potentially reducing recovery time and surgical risks. Researchers are excited about this treatment because it may provide effective relief by mechanically supporting the knee joint, offering a novel approach that could improve mobility and quality of life for patients with knee osteoarthritis.

What evidence suggests that the Atlas Knee System is effective for medial knee osteoarthritis?

Studies have shown that the Atlas Knee System, which participants in this trial will receive, can significantly aid individuals with medial knee osteoarthritis, a type of arthritis affecting the inner knee. Research indicates that about 96% of patients experienced at least a 20% reduction in pain after 12 months. Another study found that the device's benefits, which help reduce stress on the knee joint, last for at least two years. Additionally, the device maintains a high three-year survival rate of 97.3%, meaning it remains effective and intact over time. This evidence suggests the Atlas Knee System could be a promising option for managing knee pain and improving knee function.12345

Who Is on the Research Team?

RW

Rose Weinstein

Principal Investigator

Moximed

Are You a Good Fit for This Trial?

Inclusion Criteria

You may be asked to change your daily habits or behaviors.
Subjects who are able to give voluntary written informed consent to participate in this clinical investigation
This is not a criterion. Can you please provide more information or context?
See 9 more

Exclusion Criteria

Clinical symptoms or radiographic evidence of osteoarthritis in the patella-femoral compartment of the study knee defined as K&L grade ≥ 3
You have a bone disease or metabolic disorder that affects bone growth.
You have conditions that affect your blood vessels, weaken your muscles or affect your nerves and muscles.
See 26 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Atlas Knee Implant for medial knee osteoarthritis

Immediate post-enrollment

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Regular follow-up visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Atlas Knee System
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: InvestigationalExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Moximed

Lead Sponsor

Trials
8
Recruited
760+

Published Research Related to This Trial

In a study of 2033 total knee arthroplasty patients, the annual rate of adverse events decreased from 9.2% in 2002 to 5.8% in 2004, indicating improved safety over time.
Patients with congestive heart failure and chronic obstructive pulmonary disease had a significantly higher risk of adverse events during hospitalization, and experiencing an adverse event was linked to increased length of hospital stay and higher 30-day postprocedure mortality.
Adverse events after total knee arthroplasty: a national Medicare study.Huddleston, JI., Maloney, WJ., Wang, Y., et al.[2009]
A case report of a 26-year-old ex-professional athlete with knee osteoarthritis showed positive outcomes after treatment with a minimally invasive load-altering implant (Atlas System), improving pain, function, and quality of life at 6 months post-surgery.
This treatment option is particularly relevant for younger patients with early-stage knee OA who are not suitable candidates for traditional surgical interventions, suggesting a potential new pathway for managing this condition.
Treating Early Knee Osteoarthritis with the Atlas® Unicompartmental Knee System in a 26-Year-Old Ex-Professional Basketball Player: A Case Study.Slynarski, K., Lipinski, L.[2020]
A study involving 621 participants compared a home-based rehabilitation program (CORKA) to traditional outpatient physiotherapy after knee arthroplasty, finding no significant differences in patient outcomes at 6 or 12 months.
The CORKA program was found to be more cost-effective, saving £66 per participant and reducing total societal costs by £316, suggesting it could be a viable alternative to usual care despite similar effectiveness.
Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.Barker, KL., Room, J., Knight, R., et al.[2021]

Citations

A Single-Arm Study on the Atlas Unicompartmental Knee ...This study confirmed that the benefit of a joint unloading device in the management of young patients with medial knee OA is maintained over 2 years. This trial ...
Study Details | NCT02934659 | Atlas Knee System Clinical ...The primary objective of this pilot study is to collect data on the safety and effectiveness of the Atlas Knee System in subjects with medial knee ...
Feasibility of the Atlas Unicompartmental Knee System Load ...About 96.2% and 92.3% of patients experienced a ⩾20% improvement in their KOOS pain and WOMAC pain scores, respectively, at 12 months. This ...
The implantable shock absorber for medial compartment ...Studies report significant improvements in pain, functional outcomes, and survivorship, including a 97.3% three-year survival rate and a 71% ...
European Post-Market Study for Medial Knee Osteoarthritis ...The Atlas Knee System is an approved device (CE Marked) and is an extra-capsular knee implant specifically designed to treat patients with uni-compartmental, ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security