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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Moximed
- Enrollment
- 50
- Locations
- 9
- Primary Endpoint
- The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met at the 24-month follow-up:
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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):
- •Lifestyle modification
- •Weight loss, if BMI ≥35
- •Pain relievers
- •Physical Therapy
Exclusion Criteria
- •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;
- •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
Outcomes
Primary Outcomes
The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met at the 24-month follow-up:
Time Frame: Change at 24 months relative to baseline
1. Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS questionnaire with a change of ≥10 points; 2. Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS questionnaire with a change of ≥10 points; 3. Maintenance of normal range of motion (ROM) defined as: (a) Knee flexion ≥ 90 degrees; and (b) Knee extension within 10 degrees of the "neutral" or zero degree position; 4. No subsequent surgical intervention of the medial knee (including device failures requiring removal or revision); and no serious device-related adverse events; 5. Maintenance of implant integrity as evaluated by radiographic assessment. a. Implant integrity will be assessed following the Atlas Image Evaluation Protocol (102345).