Investigation of the Clinical Outcomes of Patellofemoral Arthroplasty Implanted With the MAKOplasty Knee Resurfacing System in Younger Active Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Short-term clinical outcomes of patellofemoral arthroplasty
研究概览
简要总结
The primary purpose of this investigation is to report the short-term clinical outcomes (2-3 years) of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.
详细描述
The primary purpose of this investigation is to report the short-term clinical outcomes of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.
The secondary purpose is to compare the short-term outcomes, complication rates, and survival rates of this operation to those of our historical controls of patients who underwent either osteochondral autograft transfer or autologous chondrocyte implantation for full-thickness patellofemoral articular cartilage lesions. The investigators believe these data will provide strong evidence to improve the selection criteria for patellofemoral arthroplasty.
All patients will complete validated questionnaires from the Cincinnati Knee Rating System, including the Sports Activity and Function Form, the Occupational Rating Form, and the Symptom Rating Form. Patients will also complete the SF-12 general health questionnaire. In addition to the above mentioned rating systems, patients will also complete questionnaires on post-surgical expectations and general fitness level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthroscopically demonstrated localized and isolated full-thickness articular cartilage lesions (Grade 2B or 3A-B as defined by Noyes & Stabler9) on the patellofemoral joint.
- •Lesion is symptomatic as defined by pain, swelling, locking, or catching that affects daily activities.
- •Patient provides informed consent.
- •Patient agrees to comply with postoperative rehabilitation program.
排除标准
- •Obesity (body mass index greater than 35).
- •Arthroscopically demonstrated full-thickness articular cartilage lesions (Grade 2B or 3A-B) in the other compartments of the knee.
- •Uncorrected varus or valgus malalignment
- •Uncorrected knee joint instability
- •Knee arthrofibrosis
- •Patient unwilling to comply with postoperative rehabilitation
- •Significant muscular atrophy and weakness that does not respond to rehabilitation
- •History of alcohol or drug abuse within 3 years of the operation.
- •Disabling or widespread osteoarthritis or other joint disease in any other joint.
- •Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
- •Any contraindications to surgery or other medical disorder that in the opinion of the principal investigator would interfere with the conduct of the study.
结局指标
主要结局
Short-term clinical outcomes of patellofemoral arthroplasty
时间窗: 3 years
The clinical outcomes will be determined by comparing the preoperative questionnaire data collected with the 2 and 3-year follow-up data.
次要结局
- Comparison clinical outcomes of patellofemoral arthroplasty with historical controls(3 years)
- Comparison of complications, reoperation, and failures rates of patellofemoral arthroplasty with historical controls(3 years)
研究者
Sue Barber-Westin
Director Clinical Studies
Cincinnati Sportsmedicine Research and Education Foundation