A Prospective, Randomised, Controlled Study of the Outcomes and Cost Effectiveness of Triathlon CR Knee Replacement System: Traditional Technique Versus Alternative Alignment Method.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- The assessment of difference in knee joint function between the 2 study groups as measured by the Oxford Knee Score.(OKS)
研究概览
简要总结
As many as 20% of patients are unhappy with the results of total knee replacement (TKR). Various changes to surgical technique have tried to address this but have not led to a significant improvement in the numbers of patients satisfied with their operation.
Recently, attention has focussed on alignment of the leg. When viewed from the front, a number of people do not start with a straight, mechanically aligned leg. Traditionally, when implanting a knee replacement, the surgeon tries to put the shin bone half of the knee replacement perpendicular to the floor to equalise stresses on the in and outside of the joint. However, this may result in the alignment of the leg changing considerably, straining the soft tissues around the knee and contributing to dissatisfaction with TKR.
There has been a move by some surgeons to change practice, and to implant the TKR in a way that replicates the alignment of the patient's own original knee- alternative alignment. Studies looking at alternative alignment have not shown any loss of satisfaction with results of TKR and indeed are showing some signs that in the short term, function of the knee may be better with the new technique.
The research team are planning to run a study comparing the knee replacement used in Exeter- the Triathlon- when put in place using traditional alignment versus using the alternative alignment methods. The outcomes will be assessed in various ways including patient satisfaction questionnaires, measuring muscle strength, flexibility around the knee, and by assessments of alignment of the new knee on X-rays and Computerised Tomography scans. The research team will look at short term results for satisfaction and function of the knee, and in the long term look at wear and survivorship to see if patient satisfaction with TKR can be improved.
详细描述
Research Question:
When performing total knee replacement (TKR), does the use of the alternative alignment method result in improved function by comparison to a group undergoing the same procedure but using traditional technique? Primary Aim: To identify if the group undergoing TKR using alternative alignment method have a significantly improved functional outcome at 1 year when assessed by the Minimal Clinically Important Difference (MCID) of at least 5 points in the Oxford Knee Score (OKS) by comparison to the group using traditional alignment technique.
Secondary Aims: To identify if the use of alternative alignment method when performing TKR results in:
- Shortened length of stay (LOS) in hospital
- Improved short term function when assessed by peak quadriceps or hamstrings muscle torque measured by myometer
- Lower hospital costs as a result of reduced LOS or operating time
- Enhanced improvement in patient outcome scores Knee Osteo-arthritis Outcome Score (KOOS), Oxford Knee Score (OKS), Euroquol (EQ5D) at short, mid and long term timeframes
- Enhanced positioning of the implants as assessed by a Computerised Tomography (CT) scan rotational profile assessment
- Enhanced range of knee flexion
- Any significant differences in component positioning, limb alignment or component wear
- Any significant changes in functional ability as measured by the Exeter Functional Lab protocol or Nurture activity assessment tool or the Instride Accelerometer by comparison to the TKR performed with traditional instruments.
The research team will achieve these aims:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing primary TKR at the RD+E Hospital
- •Patients must have completed a consent form for the study
- •Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study
- •Patient in whom any varus deformity present is <20°
- •The diagnosis is of tricompartmental osteoarthritis of the knee
- •Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- •Aged =/> 60 years at time of surgery
排除标准
- •Refusal to consent to the study
- •If the knee for surgery has a fixed flexion deformity ≥15°- this will be assessed by a lateral "heel-hang" x-ray of the knee for surgery
- •If the knee for surgery has a varus deformity ≥20°
- •If the knee for surgery has a valgus deformity i.e. hip/knee/ankle alignment angle <0°
- •Pre-op Oxford Knee Score <8
- •Pre-op knee flexion ability <90°
- •If the natural posterior tibial slope measured is in excess of 10°
- •Any patient whose post-operative recovery or ability to comply with the post-operative rehabilitation and assessment schedules is compromised by known existing other medical conditions
- •Pregnancy
- •Prisoners
- •A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the post-operative rehabilitation and assessment schedules
- •Patients unable to read or understand the patient information leaflet and consent form
- •Patient has a known sensitivity to device materials.
- •Patient has a Body Mass Index (BMI) ≥
- •Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- •Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
- •Patient requires bilateral total knee replacements, or has a history of unsuccessful contralateral partial or total knee replacement.
- •Patient has chronic heart failure (NYHA Stage ≥ 2)
- •Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- •Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
结局指标
主要结局
The assessment of difference in knee joint function between the 2 study groups as measured by the Oxford Knee Score.(OKS)
时间窗: 1 year after surgery
The OKS is a validated condition specific outcome measure tool.
次要结局
- An assessment of any significant differences between the 2 arms of the study in limb alignment measured on the full leg alignment X-rays(1 year after surgery)
- An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee(60 months after surgery)
- An assessment of any significant differences between the 2 arms of the study when evaluating function of the new knee joint assesses using the Exeter Functional lab protocol including Nurture and InStride accelerometer(60 months after surgery)
- An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific Patient Recorded Outcome Measure known as the Forgotten Knee Score(60 months after surgery)
- An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure known as the University of California at Los Angeles (UCLA) score(60 months after surgery)
- An assessment of any significant differences between the 2 arms of the study in component positioning measured on the full leg alignment x-ray(1 year after surgery)
- An assessment of any significant differences between the 2 arms of the study of positioning of the implants and of joint line position measured on CT scan(6 weeks after surgery)
- An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure called the Knee Osteo-arthritis Outcome Score (KOOS)(60 months after surgery)
- An assessment of any significant differences between the 2 arms of the study when analysing the results of the generic Patient Recorded Outcome Measure called the EQ5D(60 months after surgery)
- An assessment of any significant differences between the 2 arms of the study when analysing the results of the measurement of length of stay (LOS) in hospital(1 measurement after discharge from admission to time of discharge from hospital)
- An assessment of any significant differences between the 2 arms of the study when analysing the results of the SF36 generic health outcome questionnaire(60 after surgery)
- An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific patient generated outcome measure: the Knee Society Score(60 months after surgery)