Global, Prospective, Multi-Center, Non-randomized, Controlled Non-inferiority Trial to Evaluate Symptom Relief in Patients with Medial Knee Osteoarthritis (OA) Treated with the KineSpring® Knee Implant for Load Reduction Compared to High Tibial Osteotomy (HTO)
- Conditions
- degenerative joint diseaseOsteoarthritis10023213
- Registration Number
- NL-OMON41373
- Lead Sponsor
- Moximed Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Male or female subjects 25 to 80 years of age
2. Documented diagnosis of knee OA (osteoarthritis or post-traumatic osteoarthritis), which includes clinical symptoms of medial compartment osteoarthritis (pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing)
3. 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
4. Has failed at least six months of conservative treatment prior to surgery with continued OA pain. Prior conservative therapy is defined as treatment including at least one of the following:
a. Lifestyle modification
b. Weight loss, if BMI >25
c. Pain relievers
d. IA corticosteroid injections
5. Knee flexion range >=90 - <=150 degrees
6. WOMAC pain score of at least 40 (scale 0-100) at the baseline visit
7. BMI < 35 or weight < 300 lbs
8. Candidate for a high tibial osteotomy procedure
9. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
10. 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.
1. Symptomatic OA in lateral or patellofemoral compartment of affected knee, i.e. clinical symptoms or radiographic evidence of advanced OA in lateral or patellofemoral compartment of the affected knee
2. Symptomatic OA with Kellgren Lawrence Grade 4 in the contralateral knee likely to necessitate surgical intervention within 12 months of enrollment, i.e. contralateral knee has radiographic evidence of severe OA (Kellgren Lawrence Grade 4), clinical findings of severe OA (severe joint pain or limitation of movement) or symptoms that interfere with activities of daily living, stair climbing, stair descending or requires the use of an assist device
3. Tibial-femoral varus or valgus alignment >10 degrees (assessed by the investigator)
4. Flexion deformity > 10 degrees
5. Hyperextension >5 degrees
6. Severe deformities leading to impaired fixation or improper positioning of the implant
7. Pathologic ligamentous instability (>1 MCL injury or Lachman >1) as assessed by the Investigator on physical examination
8. Neuropathic pain or fibromyalgia, or any knee or other pain requiring chronic pain management.
9. Active infection, sepsis or osteomyelitis, history of infection in the target knee or distant foci of infections which may spread to the implant site
10. 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.
11. Previous osteotomy or failed knee joint replacement in the target knee
12. Known sensitivity to metal implants
13. Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder
14. Paget*s disease or metabolic disorders which may impair bone formation
15. Moderate to severe osteoporosis or pathologic fractures as evidenced by radiolucency of the femoral or tibial cortex on x-ray
16. Charcot*s joint disease or other severe neurosensory deficits
17. Immunologically suppressed or immunocompromised
18. History of systemic steroid treatment, medication use that affects bone metabolism (such as chemotherapy) within the previous 6 months, or radiotherapy within the previous 6 months
19. 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 (such as major depression, anxiety disorders, bipolar disorders and schizophrenia), history of or active alcohol/drug abuse (meeting standard diagnostic criteria described in the Diagnostic and Statistical manual for Mental Disorders DSM-IV); or other factors (e.g. planned relocation, uncooperative patient)
20. Under litigation or workers compensation for musculoskeletal injuries or disorders
21. Is either pregnant or interested in becoming pregnant during the duration of the study
22. Subjects who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months.
23. Prisoners or wards of the state.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A patient will be declared a clinical efficacy success if all of the following<br /><br>conditions are met at the 24-month follow-up:<br /><br>1. Clinically significant improvement of at least 20% from baseline for the<br /><br>WOMAC pain severity subscale with an absolute change of >=10 points.<br /><br>2. Clinically significant improvement of at least 20% from baseline for the<br /><br>WOMAC function subscale with an absolute change of >=10 points.<br /><br>3. Maintenance of normal range of motion, defined as: a) knee flexion >=90 -<br /><br><=150 degrees, and b) knee extension within 10 degrees of the *neutral* or zero<br /><br>degree position<br /><br>4. No subsequent surgical intervention of the medial compartment of the treated<br /><br>knee (including device failures requiring removal or revision); and no serious<br /><br>device-related adverse events or device failures.<br /><br>5. Maintenance of device integrity as evaluated by radiographic assessment.</p><br>
- Secondary Outcome Measures
Name Time Method