The study described here 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 KineSpring® Knee Implant System. The study population will consist of adult patients between 25 and 80 years of age that have been diagnosed with medial knee osteoarthritis and have failed to improve after at least 6 months of conservative medical treatment. A patient is considered to have a clinically important change in OA pain and function with a minimum improvement of 20% compared to baseline measures. We will collect data on the safety and effectiveness of the KineSpring in patients with primarily unicompartmental medial knee osteoarthritis through 24 months of postoperative follow-up. These data will provide insights on the overall clinical success and safety outcome of KineSpring System.
|Original language||English (US)|
|Number of pages||13|
|Journal||Journal of Long-Term Effects of Medical Implants|
|State||Published - Dec 23 2013|
- Study protocol