Atlas Knee System for Osteoarthritis

(Atlas-USA Trial)

No longer recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Moximed

Must not be taking: Steroids, Chemotherapy

Disqualifiers: Diabetes, Cancer, Osteoporosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-enrollment

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

Who Is on the Research Team?

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?

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.

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?

Group I: Investigational Experimental Treatment 1 Intervention

Intervention - Atlas Knee System device for medial knee osteoarthritis

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 260 patients undergoing total knee arthroplasty, 21% experienced adverse events, with 6% suffering from serious adverse events, highlighting the importance of monitoring complications in surgical procedures.

The use of a standardized reporting format improved the identification of adverse events, suggesting that trained paramedical staff could enhance the documentation and management of these events in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients. Kirschner, S., Lützner, J., Günther, KP., et al.[2021]

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

In a study of 260 patients with systemic-onset juvenile idiopathic arthritis (JIA), serious adverse events were more frequently reported in patients treated with canakinumab and tocilizumab, highlighting the need for careful monitoring of these biologics.

While overall tolerance to biologics was acceptable, specific risks such as infections were notably higher in patients treated with anakinra, and macrophage activation syndrome occurred more frequently in those receiving canakinumab and tocilizumab compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry. Klein, A., Klotsche, J., Hügle, B., et al.[2021]

The Atlas Knee System, a joint unloading device, showed sustained improvement in pain and function scores over 2 years in 26 young patients with medial knee osteoarthritis, confirming its effectiveness as a treatment option.

Patients also experienced a return to normal range of motion, indicating that the device not only alleviates symptoms but also restores functional mobility in individuals who had previously exhausted conservative treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Year Results of the PHANTOM High Flex Trial: A Single-Arm Study on the Atlas Unicompartmental Knee System Load Absorber in Patients With Medial Compartment Osteoarthritis of the Knee. Slynarski, K., Walawski, J., Smigielski, R., et al.[2020]

In a study of 26 young patients with medial knee osteoarthritis, the Atlas Knee System showed significant improvements in knee function and pain scores after 12 months, indicating its potential as a non-invasive treatment option.

Approximately 96.2% of patients reported a 20% or greater improvement in pain levels, suggesting that this joint unloading device could effectively manage symptoms and enhance quality of life for young patients who wish to avoid surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Atlas Unicompartmental Knee System Load Absorber in Improving Pain Relief and Function in Patients Needing Unloading of the Medial Compartment of the Knee: 1-Year Follow-Up of a Prospective, Multicenter, Single-Arm Pilot Study (PHANTOM High Flex Trial). Slynarski, K., Walawski, J., Smigielski, R., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6757501/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02934659

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5624346/

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667254525000204

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% ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02663414

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, ...