A Randomized Trial Comparing Outcomes of Unicompartmental and Total Knee Replacement for Isolated Medial Osteoarthritis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
研究概览
简要总结
This study allows patients to take part of the decision making between a unicompartment knee (partial ) or a total Knee replacement . Using the measures of a decision aid questionnaire which explicitly details the risks and benefits of both procedures.The study will use subjective (reported by patient) and objective data (which will be measured) to allow the determination if one option is superior to the other. Information gathered from this study will be used to assist future patients in selecting the surgical option that best fits their life style.
A feasibility pilot study of a randomized clinical trial will help to evaluate the outcomes of both procedures and help shape a multicentre Canadian study.
详细描述
Osteoarthritis of the knee is an increasingly common problem for many Canadians aged 50 or greater. When conservative management fails, patients are often offered a type of knee replacement as treatment. The choices are a total knee replacement or a partial knee replacement, which carry distinct advantages and disadvantages. Typically, patients with partial knee replacement have less post operative pain, quicker recovery and enhanced function with greater knee bend. There is however a higher chance of revision where the pain is not relieved or the implant fails. The decision for which replacement to offer is now primarily surgeon driven, shaped by their experience, review of evidence and capability to perform either of these options. Canadian patients would benefit from a decision making model so their own values can shape and determine the decision. This research hopes to evaluate the merits of a patient based decision aid which explicitly details the risks and benefits of both procedures as they are best understood today. Further, the quality of the current evidence is only moderately strong limited by patient selection biases and there is a need for contemporary comparative study trial of the 2 procedures to help clinicians and patients make the decision.
A feasibility pilot study of a randomized clinical trial is being proposed to evaluate the outcomes of both procedures, which will help shape a multicentre Canadian study.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria must and will be restricted to those patients who are generally considered candidates for UKA. Specific inclusion criteria will be restricted to patients:
- •Who report that most of their pain (greater than 75%) is located in the medial part of the knee on a regular basis.
- •With active range of motion from 10° of extension to 100° of flexion.
- •With an intact, competent, anterior cruciate ligament.
- •With overall limb alignment correctable to neutral, indicating a competent medial collateral ligament.
- •With radiographs showing primarily bone-on-bone disease in the medial compartment with minimal wear in both the lateral and patellofemoral compartments of the knee.
- •50 to 80 years of age.
- •With a Body Mass Index (BMI) less than
- •For the secondary outcome of motion analysis, only patients exhibiting the following characteristics will be suitable for assessment:
- •BMI of 35 or less
- •No other ipsilateral or contralateral lower limb joint disorders
排除标准
- •Those with inflammatory arthritis
- •Those with no fixed address
- •Those unable to commit to study requirements and follow-ups
结局指标
主要结局
Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
时间窗: 36 months
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. All the items are scored on a scale of 0-4; lower scores are indicative of lower disease burden. Values are summed for a combined WOMAC score (Total score ranges from 0-96, with higher scores indicating worse pain, stiffness, and functional limitations).
次要结局
- Change in Oxford Knee Score (OKS)(36 months)
- Change in Knee Society Score (KSS)(36 months)
- Quantitative analysis of gait using EMG and motion capture(12 months)
- Short Term Recovery(6 months)
- Clinical Measures(6months)