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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2024-10-31

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.

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Detailed Description

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Conditions

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Osteoarthritis, Hip Osteoarthritis Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CO THA

Computerised tomography based planning of conventional total hip arthroplasty

Group Type ACTIVE_COMPARATOR

CO THA

Intervention Type DEVICE

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

Mako THA

Mako robotic-arm assisted total hip arthroplasty

Group Type EXPERIMENTAL

Mako THA

Intervention Type DEVICE

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

Interventions

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CO THA

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

Intervention Type DEVICE

Mako THA

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No