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

University College London (UCL)

Status: Completed

Conditions: Osteoarthritis, Hip; Osteoarthritis; Surgery

Treatments: Device: Mako THA; Device: CO THA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04095845

17/0766

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

CO THA

Active Comparator group

Description:

Computerised tomography based planning of conventional total hip arthroplasty

Treatment:

Device: CO THA

Mako THA

Experimental group

Description:

Mako robotic-arm assisted total hip arthroplasty

Treatment:

Device: Mako THA