None listed
Conditions
Brief summary
This study is a single-center, prospective, open-label, safety/efficacy study enrolling up to 10 patients. Safety and efficacy are the primary objectives based on analysis of reported and observed adverse events and the WOMAC validated OA questionnaire (pain component). A series of validated subject-completed questionnaires, a visual analogue scale for pain and formal orthopaedic examination, will be performed over the course of the 60 months at the following intervals: baseline, 6 weeks, 3 months, 6, 12, 18, 24, 36, 48 and 60 months. X-ray data will be collected pre-operatively and the following post operative intervals 3, 6, 12, and 24 months.
Interventions
The interventional device name is the KineSpring PEEK System. The device is an implant that is fixed on the femoral and tibial components of the knee through a surgical procedure. Each subject will undergo a surgical procedure to implant the device which is an alternative to traditional surgeries to treat osteoarthritis (OA) of the knee.
Sponsors
Moximed, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Documented diagnosis of primary OA of the target knee made at least 6 months prior to screening, 2. Documented radiographic evidence of medial OA as demonstrated by a Kellgren-Lawrence grade of >=2 (scale 0-4) as assessed by the investigator, 3. Has continued target knee OA pain despite 6 months of conservative treatment prior to surgery, 4. Has pain in the target knee as demonstrated by a minimum score of 40 (scale 0-100) on the KOOS/WOMAC pain domain questions, 5. Aged minimum 25 years, 6. Knee flexion >=90 degrees to <=140 degrees, 7. Weight <300 lbs (136.4kg)
Exclusion criteria
1. Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint, 2. Rheumatoid arthritis or other forms of inflammatory joint disease, 3. Significant OA in lateral or patello-femoral compartment as measured by Kellgren Lawrence grade of 2 or 3, respectively, 4. Significant OA in the contralateral knee likely to necessitate surgical intervention within 12 months of enrollment, 5. Previous joint modifying surgery in the target knee within 12 months prior to planned surgery date such as ligament reconstruction or meniscus repair, cartilage transplantation, and microfracture - a. Arthroscopic surgeries for joint lavage, menisectomy, chondral debridement, and loose body removal are excluded if within 3 months prior to planned surgery date, 6. Previous osteotomy or failed knee joint replacement in the target knee, 7. Tibial-femoral varus or varus alignment >10 degrees, 8. Hyperextension >5degrees, 9. Flexion deformity greater than 10 degrees, 10. Ligamentous laxity, or meniscal instability as assessed by the investigator, 11. Uncontrolled diabetes mellitus, 12. Moderate to severe osteoporosis, 13. Concomitant immunosuppressive therapy, 14. Metabolic disorders which may impair bone formation, 15. Osteomalacia, 16. Distant foci of infections which may spread to the implant site, 17. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray, 18. Vascular insufficiency, muscular atrophy, neuromuscular disease, 19. Any significant medical condition or other factor that the Investigator feels would interfere with study participation, 20. Pregnancy or lactation, 21. Prisoners
Outcome results
None listed