NL-OMON44456已完成不适用
Evaluation of the LatellaTM Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study) - LATELLA-2
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
- 54
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
- •- History of pain for at least 6 months due to medial osteoarthritis, with failure
- •of pain relief from non*operative therapy OR from arthroscopic treatment for
- •medial osteoarthritis (see exclusion criteria for excluded procedures)
- •- Age: 30 * 70 years
- •- Weight: Less than 136 kg
- •- Kellgren*Lawrence scores: Grades 2*3
- •- Baseline KOOS pain score of * 60
- •- Baseline medial knee pain Numerical Rate Scale (NRS) (while walking) score * 4
- •- Willing and able to understand and sign the informed consent
排除标准
- •* Varus angle > 10 degrees (mechanical axis)
- •* Active Flexion > 140 degrees
- •* Joint flexion contracture > 10 degrees
- •* Contralateral knee pain (Baseline medial knee pain NRS (while walking) score * 3)
- •* Osteoporosis or other condition (e.g., hyperthyroidism, Paget*s disease, scurvy) that could compromise bone quality
- •* Permanent implant in or around the knee joint
- •* Rheumatoid arthritis
- •* Osteoarthritis in non-knee joint of the lower limb or lower back that impacts activities of daily living
- •* Immunosupressive disorders (e.g., diabetes)
- •* Chronic (6 months or longer) steroid use (with the exception of inhaled steroids)
- •* History of heterotopic ossification
- •* Ligament instability
- •* Joint instability
- •* Symptomatic evidence of moderate to severe OA in the lateral and/or patellofemoral compartments
- •* Lateral osteophytes that would underlie implant region (diagnosed via x-ray)
- •* Free floating bodies
- •* Post-traumatic osteoarthritis
- •* Arthroscopy within the last 3 months
- •* Meniscal debridement within the last 6 months
- •* Prior anterior cruciate ligament reconstruction
- •* Tight Iliotibial Band or Iliotibial Band Syndrome
- •* Femoral or tibial bony deformity
- •* Disease affecting the connective tissue or muscle
- •* Continued participation in competitive or high-impact sports (e.g.,Tegner score >6)
- •* Less than 5 year history free of 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 (with the exception of aspirin)
- •* Known metal ion allergy to titanium alloy, aluminum, or vanadium alloy
- •* Absolute or relative contraindication for MRI
- •* Substance abuse (drug or alcohol)
- •* For women of childbearing potential: pregnant, or planning to become pregnant during the course of the clinical investigation
- •* Litigation for or workers compensation for musculoskeletal injuries or disorders
- •* Are currently participating in, or have been recently exited from (within 30 days of enrollment in this study), or plan to be enrolled in another clinical study for a device or drug that may impact participation or outcome of this study
- •* Has a condition, disorder or other factor that, in the investigator*s opinion, would interfere with study participation
研究者
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