Conventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomised Controlled Trial Comparing Computerised Tomography Based Planning of Conventional Total Hip Arthroplasty Versus Mako Robotic-arm Assisted Total Hip Arthroplasty

Conditions
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Osteoarthritis, Hip, Osteoarthritis, Surgery

Intervention / Treatment
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* Device: CO THA
* Device: Mako THA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CO THA<br>Computerised tomography based planning of conventional total hip arthroplasty | Device: CO THA<br>* Replacement of arthritic hip with artificial implant using CT-based navigation and conventional technique<br>|
| Experimental: Mako THA<br>Mako robotic-arm assisted total hip arthroplasty | Device: Mako THA<br>* Replacement of arthritic hip with artificial implant using mako robotic-arm assist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of the planned pre-operative centre of rotation [COR] of the hip | 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. | 6 weeks post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinopelvic alignment | Spinopelvic alignment with plain radiographs in sitting and standing position; standing anteroposterior [A/P] lumbar spine and pelvis standing lateral lumbar spine and pelvis seated lateral lumbar spine and pelvis | Preoperatively and postoperatively at 6 months | 
| Operating time | Length of operating time in minutes | Intraoperative | 
| Blood loss | Estimated intraoperative blood loss in millilitres [ml] | Intraoperative | 
| Blood transfusion requirements | Units of blood required for transfusion intraoperatively; in whole units | Intraoperative | 
| Bone resection thickness | Thickness of bone resected during the surgical procedure in millimetres | Intraoperative | 
| Length of hospital stay | Length of patient hospital stay from admission to documented discharge; hours | 6 weeks post op | 
| Oxford hip score [OHS] | Patient recorded outcome measure via questionnaire. Scored 0-48 with 0 = poor score and 48 = best possible score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Harris Hip Score [HHS] | Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC] | Patient recorded outcome measure via questionnaire. Questions regarding pain, stiffness and disability of affected hip joint. 0= best possible score | 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] | Patient recorded outcome measure via questionnaire. Score 0-10 with 10 being best possible outcome, 0 being worst possible outcome | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D] | Health-related quality of life patient recorded outcome measure via questionnaire. Score 0-1 with 1 being best possible outcome and 0 being worst possible outcome | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Complications | Complications relating to surgery; to include development of: leg-length inequality in millimetres; deep venous thrombosis; fracture; dislocation of the prosthesis; neurovascular injury; infection of wound; deep infection involving prosthesis; re-operation or revision surgery; pulmonary embolus; heart attack; stroke; death | Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, total hip replacement, implant position, computerised tomography, makoplasty, robotic surgery