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临床试验/NCT02861521
NCT02861521已完成不适用

Reducing Postoperative Knee Flexion Contracture Recurrence by Correcting Leg Length Discrepancy in the Non-surgical Knee in Patients Undergoing Total Knee Arthroplasty for Primary Osteoarthritis: A Feasibility Study

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
1
主要终点
Function assessed by function subscales of KOOS and WOMAC.

研究概览

简要总结

Moving one's joints through their full range of motion (ROM) is crucial for health and wellbeing. Those who are unable to do so have difficulty carrying out simple activities like walking or feeding themselves. Lost joint ROM is called a contracture. Osteoarthritis (OA) is the most common form of arthritis. About a third of people with knee OA develop knee flexion contractures (KFlCs), the inability to fully straighten the knee. Having a KFlC before a knee replacement is a big risk factor for redeveloping one after the operation. Many people with a KFlC in the knee for surgery also have a KFlC in the other knee. The investigators believe that this non-surgical KFlC increases the risk of re-developing a KFlC in the surgical knee after surgery by encouraging bending of the surgical knee to avoid one leg being shorter than the other. No one has ever looked at whether fixing this leg length difference using a shoe lift would prevent this problem and there is little information to help design such a study. Here the investigators will see if testing shoe lift use for preventing KFlC is feasible. The investigators hypothesis is that a study evaluating the benefit of using a shoe lift to correct leg length difference in the non-surgical knee is feasible.

详细描述

Joint contractures are characterized by a restriction in the full passive range of motion (ROM) of a joint and are a major burden on public health. They restrict mobility, have a negative impact on quality of life, limit an individual's productivity and earning potential, and can prevent basic activities of daily living such as dressing and eating. The geriatric population is particularly vulnerable to contractures due to accumulated comorbidities leading to restricted joint movement and permanent loss of ROM.

A knee flexion contracture (KFlC) is a limitation in knee extension. Patients with KFlCs limp and are afflicted with a constant enhanced energy demand on the quadriceps muscle, putting them at higher risk for falls and injury. Walking is slow and abnormally tiring for those with KFlC such that patients may choose to walk less or not at all. Murphy et al. identified a significant increase in energy cost of walking with a KFlC of ≥15°. In addition, KFlCs cause a functional shortening in the affected limb resulting in a leg length discrepancy (LLD). LLDs contribute to even greater energy requirements for ambulation, worse pain due to premature joint wear, and are associated with knee osteoarthritis progression. One study identified shoe modification as a means of correcting this treatable risk factor. To the investigators' knowledge, no study has examined the effect of shoe modification on KFlC.

Contractures are associated with many conditions including arthritis. In the setting of osteoarthritis (OA), the most common arthritis and a world-leading cause of disability in the elderly, contractures are highly prevalent: over one third of 3,400 patients with OA presenting for total knee arthroplasty (TKA) had a KFlC. The burden of KFlC in OA is further compounded by the pre-operative contracture putting the patient at a higher risk for contracture, knee pain and poor outcome post-operatively. Loss of pre-operative ROM was found to be the best predictor of lost post-operative ROM.

During TKA, surgeons are often able to restore some or all knee ROM which transiently eliminates the contracture in the immediate post-operative period. Unfortunately, full ROM is lost over time in a notable proportion of patients. The overall incidence of KFlC following TKA has been reported to be between 1 to 5%. In patients with pre-operative KFlC, this has been reported as high as 15% with the resulting post-operative KFlCs still present at 3-year follow-up4. Patients who develop post-operative KFlC report less satisfaction, poorer function and more pain post-surgically. Post-operative loss of ROM has been described as one of the most common causes of readmission within the first 90 days after surgery and was identified as being the primary reason for nearly 20% of revision TKAs. These large percentages represent a significant number considering that 719,000 replacements were performed in the USA in 2010 and that the Ottawa hospital alone performs over 500 TKAs per year. KFlCs therefore contribute to increased health care costs.

Treatment of KFlC includes aggressive physiotherapy, therapeutic modalities, continuous passive ROM devices, bracing, manipulation under anesthesia, arthroscopy, open arthrolysis, or TKA revision surgery. Despite these numerous and costly options however, treatment is often unrewarding. Overall, contractures draw heavily on health care resources because of their chronic nature and poor response to treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients scheduled for unilateral TKA for 1° OA will be assessed for eligibility. Those meeting the American College of Rheumatology criteria for knee OA and having bilateral knee flexion contractures (KFlCs) will be recruited. KFlC will be defined as a loss of knee extension of 6 or more degrees.

排除标准

  • •Exclusion criteria include TKA for cause other than primary OA, previous septic arthritis, history of inflammatory arthritis, previous condition or known connective tissue disease that is known to affect joint range of motion.

研究组 & 干预措施

Corrective shoe lift

Experimental

Participants will be given an external shoe lift to correct post-operative leg length discrepancy (LLD).

干预措施: Shoe lift (Device)

Sham shoe intervention

Sham Comparator

Participants will be given a sham shoe intervention that does not correct post-operative leg length discrepancy.

干预措施: Sham (Device)

结局指标

主要结局

Function assessed by function subscales of KOOS and WOMAC.

时间窗: 24 months post-knee replacement

Function assessed by function subscales of KOOS and WOMAC.

Pain assessed by pain subscales of Knee injury and Osteoarthritis Outcome Score (KOOS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC).

时间窗: 3 months post-knee replacement

Pain assessed by pain subscales of KOOS and WOMAC.

Pain assessed by visual analogue scale

时间窗: 24 months post-knee replacement

Pain assessed by pain subscales of KOOS and WOMAC.

时间窗: 24 months post-knee replacement

Pain assessed by visual analogue scale

时间窗: Baseline (pre-op recruitment)

Pain assessed by visual analogue scale

Pain assessed by visual analogue scale

时间窗: 3 months post-knee replacement

Pain assessed by visual analogue scale

Pain assessed by visual analogue scale

时间窗: 6 months post-knee replacement

Pain assessed by visual analogue scale

时间窗: 12 months post-knee replacement

Pain assessed by pain subscales of Knee injury and Osteoarthritis Outcome Score (KOOS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC).

时间窗: Baseline (pre-op recruitment)

Pain assessed by pain subscales of KOOS and WOMAC.

Pain assessed by pain subscales of KOOS and WOMAC.

时间窗: 6 months post-knee replacement

Pain assessed by pain subscales of KOOS and WOMAC.

时间窗: 12 months post-knee replacement

Function assessed by function subscales of KOOS and WOMAC.

时间窗: 3 months post-knee replacement

Function assessed by function subscales of KOOS and WOMAC.

Function assessed by function subscales of KOOS and WOMAC.

时间窗: 6 months post-knee replacement

Function assessed by function subscales of KOOS and WOMAC.

Function assessed by function subscales of KOOS and WOMAC.

时间窗: 12 months post-knee replacement

Function assessed by function subscales of KOOS and WOMAC.

次要结局

  • 6-minute walk test(24 months post-knee replacement)
  • Bilateral knee range of motion measured using goniometer.(24 months post-knee replacement)
  • Leg length(24 months post-knee replacement)
  • Bilateral knee range of motion measured using goniometer.(Baseline (pre-op recruitment))
  • Bilateral knee range of motion measured using goniometer.(3 months post-knee replacement)
  • Bilateral knee range of motion measured using goniometer.(6 months post-knee replacement)
  • Bilateral knee range of motion measured using goniometer.(12 months post-knee replacement)
  • 6-minute walk test(3 months post-knee replacement)
  • 6-minute walk test(6 months post-knee replacement)
  • 6-minute walk test(12 months post-knee replacement)
  • Leg length(Baseline (pre-op recruitment))
  • Leg length(3 months post-knee replacement)
  • Leg length(6 months post-knee replacement)
  • Leg length(12 months post-knee replacement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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