This trial is active, not recruiting.

Condition osteoarthritis
Treatment medial knee compartment osteoarthritis treatment - surgical
Sponsor Moximed
Start date May 2012
End date May 2017
Trial size 225 participants
Trial identifier NCT01610505, KINE-1101


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
The KineSpring System is implanted through two medial incisions, one on the distal femur and one on the proximal tibia. Femoral and Tibial bases are fixed with screws to the femur and tibia. An absorber connects the two bases and offloads forces normally transmitted to the medial compartment of the knee.
medial knee compartment osteoarthritis treatment - surgical KineSpring
Surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment osteoarthritis.
(Active Comparator)
There are two ways to perform a high tibial osteotomy: a closed wedge osteotomy (CWO) or an open wedge osteotomy (OWO). An OWO cuts the bone, increases the angle and fills the gap with bone graft. A CWO removes a wedge of bone to achieve the change of angle. The surgery involves the gaping or wedging of a piece of bone and its removal to change the pressure points of weight-bearing activity, thus redistributing the load to the unaffected compartments of the knee. The cut surfaces of the bone are typically held together with a plate and screw system.
medial knee compartment osteoarthritis treatment - surgical KineSpring
Surgical treatment intended to reduce or eliminate pain and improve the function of a knee affected by medial compartment osteoarthritis.

Primary Outcomes

Western Ontario and McMaster Universities Arthritis (WOMAC) Pain and Function subscales. WOMAC: Self-administered, validated assessment of the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis.
time frame: 24 months post-operative
Safety: A measurement of procedure and device-related complication rates.
time frame: 24 months post-operative

Secondary Outcomes

Changes in knee pain severity
time frame: 6 weeks, and 3, 6, 12 and 24 months postoperatively compared to baseline
Changes in EQ-5D scores
time frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline
Changes in knee outcome measures (Knee Society, WOMAC, and KOOS) scores
time frame: 6 weeks and 3, 6, 12 and 24 months postoperatively compared to baseline

Eligibility Criteria

Male or female participants from 25 years up to 80 years old.

Inclusion Criteria: - Male or female subjects 25 to 80 years of age - Documented diagnosis of knee OA with a minimum of 12 months duration - Radiographic confirmation of mild to moderate medial compartment knee OA as demonstrated by a Kellgren-Lawrence grade of 1, 2 or 3 (scale 0-4) as assessed by the Investigator - Has failed at least six months of non-operative treatment with continued OA pain - Knee flexion range ≥90-≤140 degrees - WOMAC pain score of at least 40 (scale 0-100) at both the screening and baseline visits - BMI<35 or weight<300 lbs - Candidate for a high tibial osteotomy procedure - Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained - Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups. Exclusion Criteria: - Symptomatic OA with Kellgren Lawrence Grade 4 in the contralateral knee likely to necessitate surgical intervention within 12 months of enrollment - Symptomatic OA in lateral or patellofemoral compartment of affected knee - Tibial-femoral varus or valgus alignment>10 degrees - Flexion deformity>10 degrees - Hyperextension>5 degrees - Pathologic ligamentous instability (>1 MCL injury or Lachman >1) as assessed by the Investigator on physical examination - Active infection, sepsis or osteomyelitis, history of infection in the target knee or distant foci of infections which may spread to the implant site - Previous joint modifying surgery in the target knee are excluded within 12 months prior to planned study surgery date, such as ligament reconstruction or meniscus repair, cartilage transplantation, and microfracture. Arthroscopic surgeries for joint lavage, menisectomy, chondral debridement, and loose body removal are excluded within 3 months prior to planned study surgery date. - Previous osteotomy or failed knee joint replacement in the target knee - Known sensitivity to metal implants - Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder - Paget's disease or metabolic disorders which may impair bone formation - Moderate to severe osteoporosis or pathologic fractures as evidenced by radiolucency of the femoral or tibial cortex on x-ray - Charcot's joint disease or other severe neurosensory deficits - Immunologically suppressed or immunocompromised - Currently taking medications that affect bone metabolism, including steroids and chemotherapy, or are undergoing radiotherapy. - Any significant medical condition (e.g., diabetes mellitus requiring daily insulin therapy, advanced liver disease, advanced kidney disease, congestive cardiac failure, uncontrolled transient ischemic attack, cancer, radicular symptoms associated with lumbar spine pathology); significant psychiatric disorders or active alcohol/drug abuse (meeting standard diagnostic criteria described in the Diagnostic and Statistical manual for Mental Disorders (DSM-IV; or other factor (e.g. planned relocation, uncooperative patient) that the Investigator feels would interfere with study participation. - Litigation for or workers compensation for musculoskeletal injuries or disorders - Is either pregnant or interested in becoming pregnant during the duration of the study - Subjects who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months

Additional Information

Official title Global, Prospective, Multi-Center, Non-randomized, Controlled Non-inferiority Trial to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis Treated With the KineSpring® Knee Implant for Load Reduction Compared to HTO
Principal investigator Philipp Niemeyer, MD, Prof.
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Moximed.