Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NHS Lothian
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Oxford knee score
研究概览
简要总结
The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.
详细描述
Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surgeons continue to favour TKA over UKA due to a lower revision rate. The higher revision rates associated with UKA are thought to be primarily due to component malpositioning and postoperative limb malalignment.
Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease.
The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee.
A single centre randomised control trial will be carried out powered to the Oxford knee score.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Listed for elective primary TKA for end stage medial compartment osteoarthritis
- •Intact anterior cruciate ligament
- •Full thickness and good quality lateral cartilage
- •Correctable intra-articular varus deformity and intact medial collateral ligament
- •American Society of Anesthesiologists (ASA) grades 1 and 2
- •Male or female, age 50 - 75 at the time of listing for surgery
- •Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA
排除标准
- •Varus deformity of > 20 degrees
- •Fixed flexion of >10 degrees
- •Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments
- •Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- •Requires patella resurfacing or lateral compartment has significant OA
- •Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
- •Inflammatory disorder e.g. rheumatoid arthritis
- •Symptomatic foot, hip or spine pathology
- •Prior surgery (other than arthroscopy) or septic arthritis of the knee
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,
研究组 & 干预措施
Manual Total Knee Arthroplasty
This group will receive a conventional manual Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert. The surgeon will then make bone cuts using a manual jig and a hand held saw to prepare the bone surfaces for the implant. A measured resection technique will be employed with a three degree tibial slope. The surgeon will use a conventional jig alignment technique for intramedullary referencing for the femur and extra medullary referencing for the tibia. Once the implant is in position the knee is then balanced by the "feel" though a range of movement and soft tissue releases will be performed as required to balance the knee in flexion and extension.
干预措施: Triathlon (Stryker) Total Knee Arthroplasty (Device)
Robotic Assisted Unicompartmental Knee Arthroplasty
This group will receive the cemented Restoris MCK (Mako, Stryker) with a highly crossed linked (X3) polyethylene insert through a less invasive to the knee joint. Instead of using a manual jig and a hand held burr will be used to prepare the bone surfaces for the implant, the MAKO robotic arm will be used by the surgeon to cut the bone at the required alignment. The information from the CT scan will be used to create a 3D model of the patient's bony anatomy and will used to plan the positioning of the implant. Once the trackers are in place registration of the knee joint surface is performed. The specified bone cuts are then performed using the robotic arm, aiming to gap balance the knee through a full range of movement.
干预措施: MAKO™ Partial Knee Arthroplasty (Device)
结局指标
主要结局
Oxford knee score
时间窗: Baseline to 6 months
Knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best).
次要结局
- Oxford knee score and Activity and Participation Questionnaire(Baseline to 3, 6 and 12 months)
- Patient satisfaction(3, 6 and 12 months)
- Forgotten Joint Score(Baseline to 3, 6 and 12 months)
- Cost effectiveness(Baseline to 3, 6 and 12 months, and projected for the patients lifetime)
- Patient expectation pre-operative and fulfilment(Baseline to 3, 6 and 12 months)
- EQ-5D-3L(Baseline to 3, 6 and 12 months)
- Range of movement(Baseline to 3, 6 and 12 months)
- Knee stability and power(Baseline to 3, 6 and 12 months)