Atlas Knee System Clinical System Clinical Study (USA)

(Atlas-USA Trial)

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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the Atlas Knee System treatment?

The research on computer-assisted navigation in knee arthroplasty shows that using navigation systems can improve the alignment of knee implants, which is important for the success and longevity of the surgery. Although the studies do not directly mention the Atlas Knee System, they suggest that similar navigation technologies can lead to slightly better functional outcomes in the short term compared to conventional methods. ^{1 2 3 4 5}

What safety data exists for the Atlas Knee System or similar treatments?

The safety data for treatments like the Atlas Knee System, evaluated under total knee arthroplasty, shows that adverse events can occur, with rates ranging from 5.8% to 9.2% in some studies. Common issues include congestive heart failure, and identifying these events is crucial for improving medical care. ^{6 7 8 9 10}

How is the Atlas Knee System treatment different from other treatments for knee osteoarthritis?

The Atlas Knee System is unique because it is a minimally invasive implant designed to reduce the load on the medial knee, helping young patients with knee osteoarthritis who are not ideal candidates for traditional surgeries. It acts as a joint unloading device, reducing stress on the knee during activities, which can improve pain and function without the need for more invasive procedures. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial is testing the Atlas Knee System, a knee implant, in adults aged 25-80 with medial knee arthritis and significant pain. The device aims to support the knee joint and reduce pain. The Atlas Knee System was designed to fill the gap between ineffective conservative treatments and invasive surgery for young patients with medial knee osteoarthritis.

Research Team

Rose Weinstein

Principal Investigator

Moximed

Eligibility Criteria

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

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

Treatment Details

Interventions

• Atlas Knee System

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term results of the Accord total knee replacement in the Countess of Chester Hospital. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Influence of navigation system updates on total knee arthroplasty. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT. [2021]

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

Computer assisted navigation in total knee arthroplasty: comparison with conventional methods. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Functional outcome after computer-assisted versus conventional total knee arthroplasty: a randomized controlled study. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Epidemiology of total hip and knee replacement: a cross-sectional study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients. [2021]

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

Adverse events after total knee arthroplasty: a national Medicare study. [2009]

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

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry. [2021]

11. United States 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. [2020]

12. United States 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). [2020]

13. United States 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. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

[Rationale of kinematic alignment]. [2021]

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

Effects of a Medial Knee Unloading Implant on Tibiofemoral Joint Mechanics During Walking. [2020]