NL-OMON41373已完成不适用
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) - GOAL Trial Protocol No: KINE-1101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Moximed Inc.
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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.
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