NCT01132378已完成不适用
Mini-midvastus vs. Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty
Heekin Orthopedic Research Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of this study is to compare two different surgical approaches for total knee replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. Both will have the same skin incision.
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a male or non-pregnant female between the ages of 21-
- •Patient requires cemented primary total knee replacement.
- •Patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA) or avascular necrosis (AVN).
- •Patient has intact collateral ligaments.
- •Patient has signed and dated an IRB approved study specific consent form.
- •Patient is able and willing to participate in the study according to the protocol for the full length of the expected term of follow-up, and to follow their physician's directions.
- •Patient has failed to respond to conservative treatment modalities.
排除标准
- •Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee.
- •Patient is morbidly obese, >60% over ideal body weight for frame and height.
- •Patient has a deformity at the involved knee greater than 45 degrees of flexion, 45 degrees of varus or 45 degrees of valgus.
- •Patient has an active or suspected latent infection in or about the knee joint.
- •Patient has a malignancy in the area of the involved knee joint.
- •Patient has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. moderate to severe osteoporosis, Paget's disease) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- •Patient has a neurological deficit, which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- •Female patient is or plans to become pregnant during the course of the study.
- •Patient has a known sensitivity to device materials.
- •Patient has prior diagnosis of diabetic or peripheral neuropathy in operative extremity or other neurologic disease affecting limb strength
- •Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
结局指标
主要结局
Knee Society Score
时间窗: 2 year
The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain
次要结局
- Quadriceps Strength(2 year)
研究者
R. David Heekin
R. David Heekin, M.D.
Heekin Orthopedic Research Institute
研究点 (2)
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