A Prospective Randomised Controlled Trial Comparing Computerised Tomography Based Planning of Conventional Total Hip Arthroplasty Versus Mako Robotic-arm Assisted Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reproducibility of the planned pre-operative centre of rotation [COR] of the hip
研究概览
简要总结
The overall aim of this single-centre, prospective randomised controlled trial is to compare clinical, functional, and radiological outcomes in CO THA versus Mako THA. Patients undergoing Mako THA will form the investigation group and those undergoing CO THA will form the control group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has hip osteoarthritis requiring primary THA
- •Patient and surgeon are in agreement that THA is the most appropriate treatment
- •Patient is fit for surgical intervention following review by surgeon and anaesthetist
- •Patient age: Patients 18-80 years of age inclusive
- •Gender: male and female
- •Patient must be capable of giving informed consent and agree to comply with the postoperative review program
- •Patient must be a permanent resident in an area accessible to the study site
- •Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
排除标准
- •Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA
- •Patient is not medically fit for surgical intervention
- •Patients under the age of 18 or over 80 years of age
- •Patient is immobile or has another neurological condition affecting musculoskeletal function
- •Patient is already enrolled on another concurrent clinical trial
- •Patient is unable or unwilling to sign the informed consent form specific to this study
- •Patient lacks capacity to give informed consent
- •Patient is unable to attend the follow-up programme
- •Patient is non-resident in local area or expected to leave the catchment area postoperatively
结局指标
主要结局
Reproducibility of the planned pre-operative centre of rotation [COR] of the hip
时间窗: 6 weeks post-op
Radiographic assessment of the COR will be performed using coronal plane images from the preoperative pelvic CT scan and postoperative CT scanogram at six weeks after surgery. The COR will be determined using the centre of a circle encompassing the native femoral head on the contralateral side in the preoperative films and the prosthetic femoral head on the ipsilateral side on postoperative films. The horizontal COR will be calculated by measuring the distance between the COR and a line running directly perpendicular from the midline of the pelvis, which is defined as a line connecting the middle of the pubic symphysis and the middle of the inter-sacroiliac line. The vertical COR will be calculated by measuring the distance of a line that runs directly perpendicular from the inter-tear drop line to the COR.
次要结局
- Blood transfusion requirements(Intraoperative)
- Bone resection thickness(Intraoperative)
- European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D](Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Blood loss(Intraoperative)
- Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC](Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- University of California at Los Angeles hip [UCLA](Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Operating time(Intraoperative)
- Length of hospital stay(6 weeks post op)
- Harris Hip Score [HHS](Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Spinopelvic alignment(Preoperatively and postoperatively at 6 months)
- Oxford hip score [OHS](Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)
- Complications(Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)