The purpose of the post-market study is to demonstrate that the KineSpring System is non-inferior to high tibial osteotomy in safety and effectiveness in the treatment of symptoms associated with osteoarthritis of the medial compartment of the knee. The primary objective of the study will be to:

  • Demonstrate the non-inferiority of the KineSpring System compared to the standard surgical, high tibial osteotomy procedure in improving pain and function outcomes (as measured by the WOMAC pain and function subscales) at 24 months in patients with primarily uni-compartmental medial knee osteoarthritis.
  • Demonstrate that the KineSpring System is safe as measured by procedure and device-related complication rates through 24 months post-operatively

Read more: http://www.clinicaltrials.gov/ct2/show/NCT01610505?cond=%22Arthritis%22&lup_s=10/31/2013&lup_d=30