NL-OMON27446招募中不适用
Real-life and challenging gait skills to evaluate performance after cruciate-retaining TKA:The Challenge CR study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria for patients undergoing CR TKA:
- •Non-inflammatory knee osteoarthritis, which is confirmed by radiology (Kellgren & Lawrence = 2).
- •Set to receive a primary cemented total knee arthroplasty.
- •Age between 40 and 80 years, inclusive, on the day of the operation.
- •In stable health (ASA-score = 3) and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk.
- •Patient has a correctable or <10° rigid (non-correctable) varus or valgus deformity of the knee.
- •Participants must be able to give informed consent.
- •Inclusion criteria for healthy controls:
- •Age between 40 and 80 years, inclusive, on the day of the baseline measurement.
- •In stable health (ASA-score = 3)
- •Participants must be able to give informed consent.
排除标准
- •Exclusion criteria for patients undergoing CR TKA:
- •BMI > 35.
- •Patient has had major, non-arthroscopic surgery to the study knee, including high tibial osteotomy.
- •Patient has an active, local infection or systemic infection • Prior high-energy trauma to the affected knee or prior history of posterior cruciate ligament rupture.
- •Suspicion of posterior cruciate ligament rupture at clinical examination.
- •Incomplete or insufficient tissue surrounding the knee.
- •Severe damage to any knee ligament other than the anterior cruciate ligament
- •Documented osteoporosis with patient in active medical treatment.
- •Patient has physical, emotional or neurological conditions that would compromise compliance with post-operative rehabilitation and follow-up.
- •Bone quality compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis • Fixed flexion deformity >10 degrees (passive extension lag)
- •> 30 degrees extension deficit (active restraint to extension)
- •Patient does not have a proper functioning patella tendon on the affected side measured as inability of active extension of the knee
- •Impaired extensor strength defined as MRC Grade < 4.
- •Undergone patellectomy in the knee receiving CR-TKA
- •Moderate to severe knee pain in the contralateral knee defined as an average score of >4 on items 3-6 of the Short Brief Pain Inventory
- •Moderate to severe hip or ankle pain defined as an average score of >4 on items 3-6 of the Short Brief Pain Inventory
- •Previous knee, hip or ankle replacement surgery, or is planned to have a knee (contralateral), hip or ankle replacement in the next 12 months.
- •Any musculoskeletal or neurological disease, or uncorrected visual impairment other than osteoarthritis that impairs gait or balance.
- •Exclusion criteria for healthy control subjects:
- •Moderate to severe knee pain in one or both knees defined as an average score of >4 on items 3-6 of the Short Brief Pain Inventory
- •Moderate to severe hip or ankle pain defined as an average score of >4 on items 3-6 of the Short Brief Pain Inventory
- •Previous knee, hip or ankle replacement surgery, or is planned to have a knee, hip or ankle replacement in the next 24 months.
- •Any musculoskeletal or neurological disease, or uncorrected visual impairment other than osteoarthritis that impairs gait or balance.
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