Osteoarthritis, KneeAtlas-USANCT02934659
Atlas Knee System Clinical System Clinical Study (USA)
A study testing Atlas(TM) Knee System in people with Osteoarthritis, Knee, run by Moximed at 9 sites in United States.
Trial summary
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 osteoarthritis through 24 months postoperative follow-up. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Atlas(TM) Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2016to 2 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects age 25 to 80 years at time of screening
- Clinical symptoms (such as pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing) and radiographic evidence of osteoarthritis in the medial compartment of the knee
- Weight-bearing Fixed Flexion view is recommended to verify radiographic evidence of osteoarthritis
- KL Grade 1-4, except those with bony erosion
- Has pain in the study knee as demonstrated by a minimum score of 40 (scale 0-100) on the WOMAC pain questions in KOOS
- Has failed at least six (6) months of non-operative treatment with continued osteoarthritis (OA) pain. Prior treatment is defined as treatment with at least one of the following interventions (listed on the AAOS Clinical Practice Guidelines on the Treatment of Osteoarthritis of the Knee Non-arthroplasty):
Show all 16Show fewer
- Lifestyle modification
- Weight loss, if BMI ≥35
- Pain relievers
- Physical Therapy
- Orthotics (Splints, Braces)
- Intra-Articular (IA) corticosteroid injections.
- Knee flexion ≥90⁰
- Body Mass Index (BMI) of <35 or weight <300 lbs.
- Subjects who are able to give voluntary written informed consent to participate in this clinical investigation
- Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures, and are willing to return for all the required post-treatment follow up visits.
Who cannot join
- Clinical symptoms or radiographic evidence of osteoarthritis in the lateral compartment of the study knee defined as Kellgren \& Lawrence (K\&L) grade of > 1
- Clinical symptoms or radiographic evidence of osteoarthritis in the patella-femoral compartment of the study knee defined as K\&L grade ≥ 3
- Clinical symptoms or radiographic evidence of osteoarthritis at the contralateral knee that would preclude activity of daily living, stair climbing, stair descending, or requires the use of an assist device
- Tibial-femoral alignment of more than 10⁰ of varus, or more than 6⁰ of valgus, as measured using anatomical axis on a standing Hip-Knee-Ankle or long standing AP view X-ray OR Hip-Knee-Ankle alignment of more than 16⁰ of varus, or more than 0⁰ of valgus, as measured using mechanical axis on a standing Hip-Knee-Ankle AP view x-ray
- Previous joint modifying surgery in the study knee within 12 months prior to planned surgery date such as ligament reconstruction, meniscus repair, cartilage transplantation, and microfracture
- Arthroscopic surgeries for joint lavage, meniscectomy, chondral debridement, and loose body removal are excluded if within 3 months prior to planned surgery date;
Show all 44Show fewer
- Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint;
- Previous lateral meniscectomy >30% of the study knee
- Previous patellar surgery in the study knee
- Previous osteotomy or failed knee joint replacement in the study knee
- Hyperextension >5⁰
- Flexion contracture > 10⁰
- Pathologic ligamentous or meniscal instability (Lachman > 1) as assessed by the Investigator;
- Suspected or documented allergy or hypersensitivity to cobalt, chromium, iron, or nickel metals;
- Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder;
- Paget's disease or metabolic disorders which may impair bone formation;
- Known or suspected diagnosis of Osteomalacia;
- Known or suspected diagnosis of Osteonecrosis;
- Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray;
- Osteoporosis or radiolucency of the femoral or tibial cortex on x-ray suggestive of moderate to severe osteoporosis, pathologic fractures, or bone mineral density T score of > 2.5 Standard Deviation (SD) below young adult reference mean (all subjects will be screened for risk of osteoporosis using the validated Osteoporosis Self-Assessment Tool (OST) score, subjects with high risk will undergo a DEXA scan to determine eligibility;
- Charcot's joint disease or other severe neurosensory deficits;
- Vascular insufficiency, muscular atrophy, neuromuscular disease;
- Immunologically suppressed or immunocompromised;
- History of systemic steroid treatment, medication use that affects bone metabolism (such as chemotherapy) within the previous 6 months, or radiotherapy within the previous 6 months
- Any significant medical condition including:
- Diabetes mellitus requiring daily insulin therapy
- Neuropathic pain or fibromyalgia, or any knee or other pain requiring chronic pain management
- Advanced liver and kidney diseases
- Congestive heart failure
- Uncontrolled transient ischemic attack
- Cancer
- HIV (immunocompromised subject)
- Radicular symptoms associated with lumbar spine pathology
- Neurological disorders that result in gait disturbance
- Restless leg syndrome
- History of complex regional pain syndrome (Reflex Sympathetic Dystrophy (RSD); l. Significant psychiatric disorders (such as major depression, anxiety disorders, bipolar disorder, and schizophrenia); m. History or active substance and alcohol dependence and abuse (meeting standard diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders DSM-IV)
- Other factors that the investigator feels would interfere with the participation and completion of the study:
- Planned relocation
- Litigation for or workers compensation for musculoskeletal injuries or disorders
- Uncooperative subject
- Or any other reason.
- Pregnancy or planning to become pregnant
- Subjects who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months
- Prisoners or wards of the state.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02130
University of Virginia, Dept. of Orthopaedic Surgery
Charlottesville, Virginia, 22908
Ohio State University
Columbus, Ohio, 43202
Duke University
Durham, North Carolina, 27705
Orthropaedic Research Foundation
Greenwood, Indiana, 46143
Houston Methodist
Houston, Texas, 77030
Hospital for Special Surgery (HSS)
New York, New York, 10021
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Prospective, Multi-Center, Single Arm, Pilot Study to Evaluate Symptom Relief in Subjects With Medial Knee Osteoarthritis Treated With the AtlasTM Knee System for Load Reduction
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 osteoarthritis through 24 months postoperative follow-up.
Read the detailed description
This study is designed as a prospective, multicenter, open-label, single arm, pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the Atlas Knee Implant. The study population will consist of adult subjects age 25 to 80 years, with a diagnosis of medial knee osteoarthritis (Kellgen and Lawrence Grades 1-4, except those with bony erosions) and has pain in the study knee demonstrated as an overall WOMAC pain score of ≥ 40 (scale 0-100).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Atlas(TM) Knee System
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atlas(TM) Knee SystemDevice
Also called Atlas System
The Atlas System is an extra-capsular knee implant designed to unload the medial knee.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Intervention - Atlas Knee System device for medial knee osteoarthritis Receives: Device: Atlas(TM) Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months.
- WOMAC pain questions in the KOOS questionnaire (20% and 10 point improvement from baseline)
- WOMAC function questions in the KOOS questionnaire (20% and 10 point improvement from baseline)
- Maintenance of normal range of motion (ROM, knee flexion >=90 degrees and knee extension within 10 degrees of neutral)
- No subsequent surgical intervention of the medial knee; and no serious device-related adverse events
- Maintenance of implant integrity as evaluated by radiographic assessment.
Measured: Change at 24 months relative to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion9 Jul 2019
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moximed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rose Weinstein, Study director, Moximed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934659
- Sponsor's protocol ID
- CP0003 (formerly 102347)
- Acronym
- Atlas-USA
- Status last verified
- Jun 2026
- First submitted
- 13 Oct 2016
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Single Arm, Pilot Study to Evaluate Symptom Relief in Subjects With Medial Knee Osteoarthritis Treated With the AtlasTM Knee System for Load Reduction
- ClinicalTrials.gov ID
- NCT02934659
- Acronym / sponsor ID
- Atlas-USA / CP0003 (formerly 102347)
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MoximedIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 26 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 osteoarthritis through 24 months postoperative follow-up.
Detailed description
This study is designed as a prospective, multicenter, open-label, single arm, pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the Atlas Knee Implant. The study population will consist of adult subjects age 25 to 80 years, with a diagnosis of medial knee osteoarthritis (Kellgen and Lawrence Grades 1-4, except those with bony erosions) and has pain in the study knee demonstrated as an overall WOMAC pain score of ≥ 40 (scale 0-100).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: Atlas(TM) Knee SystemIntervention - Atlas Knee System device for medial knee osteoarthritis |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subjects age 25 to 80 years at time of screening
- Clinical symptoms (such as pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing) and radiographic evidence of osteoarthritis in the medial compartment of the knee
- Has pain in the study knee as demonstrated by a minimum score of 40 (scale 0-100) on the WOMAC pain questions in KOOS
- Has failed at least six (6) months of non-operative treatment with continued osteoarthritis (OA) pain. Prior treatment is defined as treatment with at least one of the following interventions (listed on the AAOS Clinical Practice Guidelines on the Treatment of Osteoarthritis of the Knee Non-arthroplasty):
- Knee flexion ≥90⁰
Key exclusion criteria (44 listed)
- Clinical symptoms or radiographic evidence of osteoarthritis in the lateral compartment of the study knee defined as Kellgren \& Lawrence (K\&L) grade of > 1
- Clinical symptoms or radiographic evidence of osteoarthritis in the patella-femoral compartment of the study knee defined as K\&L grade ≥ 3
- Clinical symptoms or radiographic evidence of osteoarthritis at the contralateral knee that would preclude activity of daily living, stair climbing, stair descending, or requires the use of an assist device
- Tibial-femoral alignment of more than 10⁰ of varus, or more than 6⁰ of valgus, as measured using anatomical axis on a standing Hip-Knee-Ankle or long standing AP view X-ray OR Hip-Knee-Ankle alignment of more than 16⁰ of varus, or more than 0⁰ of valgus, as measured using mechanical axis on a standing Hip-Knee-Ankle AP view x-ray
- Previous joint modifying surgery in the study knee within 12 months prior to planned surgery date such as ligament reconstruction, meniscus repair, cartilage transplantation, and microfracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atlas(TM) Knee SystemAlso: Atlas SystemThe Atlas System is an extra-capsular knee implant designed to unload the medial knee. | Device | Investigational |
Primary outcome
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months.
Time frame: Change at 24 months relative to baseline
1. WOMAC pain questions in the KOOS questionnaire (20% and 10 point improvement from baseline) 2. WOMAC function questions in the KOOS questionnaire (20% and 10 point improvement from baseline) 3. Maintenance of normal range of motion (ROM, knee flexion >=90 degrees and knee extension within 10 degrees of neutral) 4. No subsequent surgical intervention of the medial knee; and no serious device-related adverse events 5. Maintenance of implant integrity as evaluated by radiographic assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Weinstein study director
Moximed
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atlas(TM) Knee System in people with Osteoarthritis, Knee, run by Moximed at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Endpoint of This Pilot Study is the Number of Subjects Who Were Deemed a Success for Each of the Following Measures at 24 Months. (time frame: Change at 24 months relative to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.