Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty: The Minimally Invasive Surgery Mini-Incision (MIS) TKA, Standard Para-Patellar Surgery TKA and the Unicompartmental Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Isokinetic and isometric quadriceps and hamstring strength
研究概览
简要总结
A functional outcomes comparison study of three surgical techniques using minimally invasive surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and the unicompartmental knee arthroplasty performed over a 2+ year post-op period.
详细描述
The purpose of this research study is to compare post-operative knee function of persons who have undergone one of three types of knee arthroplasty for the treatment of knee osteoarthritis. A variety of functional performance tests will be assessed and compared using a group of evaluations including: functional activity performance tests and questionnaires; leg strength; knee range of motion; and forces at the knee during a series of activities (walking, bending, stepping etc.) via a motion analysis system. The study will compare the three surgical subject groups and one group of healthy, non-surgical subjects for a total of 100 subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •TKA subjects:
- •Patients requiring primary knee arthroplasty;
- •Knee osteoarthritis;
- •Subject has sufficient quantity or quality of bone support;
- •Subject has no previous or active infection in the affected joint or systemic infection;
- •Subject judged to be available for follow-up through at least 1 year postoperative;
- •All subjects in arthroplasty groups will be between 50-70 years of age
- •Healthy subjects:
- •Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
- •All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
- •All healthy persons will be 40-70 years.
排除标准
- •Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
- •Unable to return for follow up x-rays and clinical evaluation;
- •Unable to comprehending study protocol for any reason;
- •Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
- •Subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include Subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), Subjects receiving therapy to prevent homograft rejection, Subjects who have a documented history of acquired immunodeficiency syndrome (AIDS), or auto-immune diseases;
- •Subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.
结局指标
主要结局
Isokinetic and isometric quadriceps and hamstring strength
时间窗: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
次要结局
- American Academy Orthopaedic Surgeons Knee Score(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- Knee loading pattern during gait & chair rise(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- University California Los Angeles Activity Score(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- Knee adductor moment during gait and chair rise(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- Visual Analog Pain Scale(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- Sit to Stand to Sit (STSTS) Test(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- Timed "Up & Go" Test(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)
- Stair Test(Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years)