WithdrawnNot Applicable

European Post-Market Study for Medial Knee Osteoarthritis Treated With the Atlas Knee System for Load Reduction

Stopped: Study never started and will never be started

0Started 2016-03

Plain-language 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.

Who can participate

Age range25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. Pain relievers;
✓. Physical therapy;

Exclusion criteria

✕. 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;
✕. Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder;
✕. Excessive scarring of soft tissue structures of the medial knee;

What they're measuring

Pain

Timeframe: Baseline and 24 month

Function

Timeframe: Baseline and 24 month

Knee range of motion

Timeframe: Baseline and 24 month

Monitoring of adverse events

Timeframe: Baseline to 24 month

Trial details

NCT IDNCT02663414

SponsorMoximed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11

View on ClinicalTrials.gov More Osteoarthritis (OA) of the Medial Knee Compartment trials

Who can participate

Age range25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. Pain relievers;
✓. Physical therapy;

Exclusion criteria

✕. 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;
✕. Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder;
✕. Excessive scarring of soft tissue structures of the medial knee;