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

University College, London60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis, Hip Osteoarthritis Surgery

Interventions

CO THADEVICE

Replacement of arthritic hip with artificial implant using CT-based navigation and conventional technique

Mako THADEVICE

Replacement of arthritic hip with artificial implant using mako robotic-arm assist

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

UCL Hospital NHS Foundation Trust

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks post-op

Secondary Outcomes

Spinopelvic alignment

Spinopelvic alignment with plain radiographs in sitting and standing position; 1. standing anteroposterior \[A/P\] lumbar spine and pelvis 2. standing lateral lumbar spine and pelvis 3. seated lateral lumbar spine and pelvis

Time frame: Preoperatively and postoperatively at 6 months

Operating time

Length of operating time in minutes

Time frame: Intraoperative

Blood loss

Estimated intraoperative blood loss in millilitres \[ml\]

Time frame: Intraoperative

Blood transfusion requirements

Units of blood required for transfusion intraoperatively; in whole units

Time frame: Intraoperative

Bone resection thickness

Data from ClinicalTrials.gov

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