Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis Versus the Use of Non-surgical Treatment: Randomized Clinical Trial and Comparison of Therapies for Medial Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- WOMAC Pain at 6 Months
研究概览
简要总结
Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment.
This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization is programmed within the Electronic Data Capture system to ensure that the groups are unbiased and that the results are reliable, independent from the participant, investigator, and sponsor. The outcomes assessor remains independent from the participant, investigator and the sponsor.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Activity exacerbated knee pain isolated to the medial compartment and not global in nature
- •WOMAC pain ≥ 40
- •Failed to find relief in non-surgical treatment modalities
排除标准
- •Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
- •Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
- •Ligamentous instability
- •Active or recent knee infection
- •Inflammatory joint disease, including sequelae of viral infections
- •Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
- •History of keloid, hypertrophic or contracture scaring
- •Propensity for restrictive scar formation or adhesions with prior procedures
研究组 & 干预措施
MISHA Knee System
The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.
干预措施: MISHA Knee System (Device)
Non-Surgical Treatment
The non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.
干预措施: Non-Surgical Treatment (Other)
结局指标
主要结局
WOMAC Pain at 6 Months
时间窗: 6 Months
Improvement in WOMAC Pain in the MISHA arm compared to the non-surgical arm measured on the initial cohort who complete the 6-month follow-up visit
次要结局
- WOMAC Function at 6 Months(6 Months)