NL-OMON41663已完成不适用
Evaluation of the Latella Implant System for Lateralization of the Iliotibial Band to Offload the Medial Condyle for Pain Relief in Patients with Medial Osteoarthritis * A Safety Study - COTERA-1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cotera, Inc.
- 入组人数
- 10
研究概览
简要总结
Trial is onging in other countries
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. History of pain diagnosed as due to medial osteoarthritis with failure of pain relief from non-operative therapy
- •OR failure of pain relief 6 months post arthroscopic treatment for medial osteoarthritis (see exclusion criteria for excluded procedures)
- •2. Age: 30 * 65 years
- •3. Weight: Less than 110 kg
- •4. Kellgren-Lawrence scores: Grades 2-3
- •5. Willing and able to understand and sign the informed consent
排除标准
- •* Varus angle > 10 degrees
- •* Osteoporosis
- •* Rheumatoid arthritis
- •* Immunosupressive disorders, for example, diabetes
- •* Chronic steroid use
- •* History of heterotopic ossification
- •* Ligament instability
- •* Joint instability
- •* Capsule contracture
- •* Ligament contracture
- •* Radiologic evidence of patellar osteoarthritis which in the opinion of the treating physician would preclude enrollment
- •* History of patellar instability including: Subluxation, Dislocation, Maltracking, Excessive anterior knee pain
- •* Radiologic evidence of lateral osteoarthritis
- •* Post-traumatic osteoarthritis
- •* Lateral osteophytes that would underlie implant region (diagnosed via x-ray)
- •* Free floating bodies
- •* Prior surgery or trauma in or near the intended implant site which would create scar tissue and interfere with the implant surgery.
- •o NOTE: Partial medial meniscectomy will be allowed
- •* Prior anterior cruciate ligament reconstruction
- •* Tight Illiotibial Band or Illiotibial Band Syndrome
- •* Femoral or tibial bone deformity
- •* Bone metabolic disease not associated with osteoarthritis
- •* Disease affecting the connective tissue or muscle
- •* Continued participation in contact sports
- •* Less than 5 year history free of lung, colorectal, breast, thyroid, prostate, or kidney cancer
- •* Less than 5 year history free of primary bone tumors
- •* History of stroke, upper limb or lower limb motor disorders
- •* Bleeding diathesis
- •* Chronic use of anticoagulants
- •* Metal ion allergy
- •* Absolute or relative contraindication for MRI
- •* No fixed abode
- •* Substance abuse (drug or alcohol)
- •* For women of childbearing potential: pregnant, or willing to become pregnant during the course of the clinical investigation
- •* Have been exited from in another clinical study less than 30 days prior to enrollment in this clinical study, currently participating in another clinical study or plan to be enrolled in another clinical study during the course of this study.
研究者
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