Osteoarthritis (OA) of the Medial Knee CompartmentAtlas-PMCFNCT02663414
European Post-Market Study for Medial Knee Osteoarthritis Treated With the Atlas Knee System for Load Reduction
A study testing Atlas Knee System in people with Osteoarthritis (OA) of the Medial Knee Compartment, run by Moximed.
Trial summary
The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Medial Knee Compartment
- What is being tested?
- Atlas Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, older than 25 years of age;
- Have clinical symptoms in the study knee such as pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing;
- Radiographic confirmation of osteoarthritis of the medial knee compartment without bony erosion and best assessed using a Rosenberg view X-ray;
- Have failed at least 6 months of conservative therapy prior to surgery with continued OA pain. Prior conservative therapy is defined as treatment including at least one of the following (OARSI Recommendations)9:
- Lifestyle modification;
- Weight loss, if BMI >35;
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- Pain relievers;
- Physical therapy;
- Assist devices (Canes, Orthotics, Braces, etc.);
- Intra-articular (IA) injections.
- Have active knee flexion ≥ 90⁰;
- Are able to give voluntary, written informed consent to participate in this clinical investigation.
- Are, in the opinion of the Clinical Investigator, able to understand this clinical investigation, cooperate with the investigational procedures, and are willing to return for all required post-treatment follow up visits.
Who cannot join
- Clinical symptoms and radiographic evidence of OA in the lateral compartment of the study knee;
- Clinical symptoms and radiographic evidence of OA in the patella-femoral compartment of the study knee;
- Tibio-femoral alignment of > 10⁰ of varus, or > 6° of valgus, as measured using anatomical axis on a long standing (Hip-Knee-Ankle) antero-posterior (AP) view X-ray, or tibio-femoral alignment of > 16⁰ of varus, or > 0⁰ of valgus as measured using mechanical axis on a long 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, medial meniscectomy, chondral debridement, and loose body removal if within 3 months prior to planned surgery date; Note: concomitant diagnostic arthroscopy including debridement during Atlas procedure is permitted.
- Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint;
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- Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder;
- Excessive scarring of soft tissue structures of the medial knee;
- Hyperextension > 10⁰;
- Pathologic ligamentous instability (> 1 Medial collateral ligament injury or Lachman > 1 without hard stop) as assessed by the Investigator on physical examination;
- Severe deformities leading to impaired fixation or improper positioning of the implant;
- Paget's disease or metabolic disorders which may affect bone formation;
- Known or suspected diagnosis of Osteomalacia;
- Known or suspected diagnosis of Osteonecrosis;
- Known or suspected diagnosis of Osteoporosis;
- Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray;
- 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 and other factors that the investigator feels would interfere with the participation and completion of the study;
- Pregnancy;
- Subjects who are currently enrolled in another clinical investigation that could affect the results of this investigation.
About this study
Official title: European Post-Market, Prospective, Multi-Center, Single-Arm Study to Evaluate Symptom Relief in Subjects With Medial Knee Osteoarthritis Treated With the Atlas Knee System for Load Reduction
The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period.
Read the detailed description
The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period. This study is designed as a post-market, prospective, multicenter, single arm study. The study population will consist of adult subjects older than 25 years of age, with a diagnosis of symptomatic and radiographic OA of the medial knee compartment.
- Being tested
- Atlas Knee System
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atlas Knee SystemDevice
Also called Atlas System
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, medial knee osteoarthritis (OA).
| Study group | Role | What they receive |
|---|---|---|
| Atlas device | Experimental | Each patient in this arm will receive the Atlas Knee System device on the medial side of the symptomatic knee. Receives: Device: Atlas Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Change from baseline to 24 months in pain measured by the Knee injury and Osteoarthritis outcome score (KOOS).
Measured: Baseline and 24 month
Function
Change from baseline to 24 months in patients functional outcome using the Knee injury and Osteoarthritis outcome score (KOOS).
Measured: Baseline and 24 month
Knee range of motion
No change from baseline to 24 months in Knee range of motion as measured by Investigator Orthopedic examination.
Measured: Baseline and 24 month
Monitoring of adverse events
Type, frequency, severity, and relatedness of adverse events will be assessed throughout the study.
Measured: Baseline to 24 month
Secondary outcomes (3)
Function
Change from baseline to 24 months in patients functional outcome measured by the Knee Society score (KSS).
Measured: Baseline and 24 month
Activity
Change from baseline to 24 months in patients activity level using the University of California, Los Angeles (UCLA) activity scale.
Measured: Baseline and 24 month
Health outcome
Change from baseline to 24 months in patients health outcome using a health outcome measure (EQ-5D).
Measured: Baseline and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Study never started and will never be started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the Medial Knee CompartmentStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moximed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tessa Yamut, Study chair, Moximed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663414
- Sponsor's protocol ID
- CLIN-102359
- Acronym
- Atlas-PMCF
- Status last verified
- Mar 2019
- First submitted
- 14 Jan 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Post-Market, Prospective, Multi-Center, Single-Arm Study to Evaluate Symptom Relief in Subjects With Medial Knee Osteoarthritis Treated With the Atlas Knee System for Load Reduction
- ClinicalTrials.gov ID
- NCT02663414
- Acronym / sponsor ID
- Atlas-PMCF / CLIN-102359
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started and will never be started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MoximedIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period.
Detailed description
The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period. This study is designed as a post-market, prospective, multicenter, single arm study. The study population will consist of adult subjects older than 25 years of age, with a diagnosis of symptomatic and radiographic OA of the medial knee compartment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atlas device | Experimental | Device: Atlas Knee SystemEach patient in this arm will receive the Atlas Knee System device on the medial side of the symptomatic knee. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, older than 25 years of age;
- Have clinical symptoms in the study knee such as pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing;
- Radiographic confirmation of osteoarthritis of the medial knee compartment without bony erosion and best assessed using a Rosenberg view X-ray;
- Have failed at least 6 months of conservative therapy prior to surgery with continued OA pain. Prior conservative therapy is defined as treatment including at least one of the following (OARSI Recommendations)9:
- Have active knee flexion ≥ 90⁰;
Key exclusion criteria (23 listed)
- Clinical symptoms and radiographic evidence of OA in the lateral compartment of the study knee;
- Clinical symptoms and radiographic evidence of OA in the patella-femoral compartment of the study knee;
- Tibio-femoral alignment of > 10⁰ of varus, or > 6° of valgus, as measured using anatomical axis on a long standing (Hip-Knee-Ankle) antero-posterior (AP) view X-ray, or tibio-femoral alignment of > 16⁰ of varus, or > 0⁰ of valgus as measured using mechanical axis on a long 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, medial meniscectomy, chondral debridement, and loose body removal if within 3 months prior to planned surgery date; Note: concomitant diagnostic arthroscopy including debridement during Atlas procedure is permitted.
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 Knee SystemAlso: Atlas SystemThe Atlas Knee System is an approved device (CE Marked) and is an extra-capsular knee implant specifically designed to treat patients with uni-compartmental, medial knee osteoarthritis (OA). | Device | Atlas device |
Primary outcome
Pain
Time frame: Baseline and 24 month
Change from baseline to 24 months in pain measured by the Knee injury and Osteoarthritis outcome score (KOOS).
Function
Time frame: Baseline and 24 month
Change from baseline to 24 months in patients functional outcome using the Knee injury and Osteoarthritis outcome score (KOOS).
Knee range of motion
Time frame: Baseline and 24 month
No change from baseline to 24 months in Knee range of motion as measured by Investigator Orthopedic examination.
Monitoring of adverse events
Time frame: Baseline to 24 month
Type, frequency, severity, and relatedness of adverse events will be assessed throughout the study.
3 secondary outcomes
Function
Time frame: Baseline and 24 month
Activity
Time frame: Baseline and 24 month
Health outcome
Time frame: Baseline and 24 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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.
Tessa Yamut study chair
Moximed
Questions about this trial
What is this clinical trial studying?
A study testing Atlas Knee System in people with Osteoarthritis (OA) of the Medial Knee Compartment, run by Moximed.
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 13 inclusion and 23 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: withdrawn, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain (time frame: Baseline and 24 month). The study lists 4 primary outcomes in all. 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 21 Mar 2019.