Skip to main content
OpenTrials
Completed

NCT Number: NCT04095845

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCL Hospital NHS Foundation Trust

London, NW1 2BU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO THA

Device

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

Mako THA

Device

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

Primary outcomes

  1. Reproducibility of the planned pre-operative centre of rotation [COR] of the hip

    Time frame: 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.

Secondary outcomes

  1. Spinopelvic alignment

    Time frame: Preoperatively and postoperatively at 6 months

    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

  2. Operating time

    Time frame: Intraoperative

    Length of operating time in minutes

  3. Blood loss

    Time frame: Intraoperative

    Estimated intraoperative blood loss in millilitres [ml]

  4. Blood transfusion requirements

    Time frame: Intraoperative

    Units of blood required for transfusion intraoperatively; in whole units

  5. Bone resection thickness

    Time frame: Intraoperative

    Thickness of bone resected during the surgical procedure in millimetres

  6. Length of hospital stay

    Time frame: 6 weeks post op

    Length of patient hospital stay from admission to documented discharge; hours

  7. Oxford hip score [OHS]

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure via questionnaire. Scored 0-48 with 0 = poor score and 48 = best possible score

  8. Harris Hip Score [HHS]

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome

  9. Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC]

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure via questionnaire. Questions regarding pain, stiffness and disability of affected hip joint. 0= best possible score

  10. University of California at Los Angeles hip [UCLA]

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    Patient recorded outcome measure via questionnaire. Score 0-10 with 10 being best possible outcome, 0 being worst possible outcome

  11. European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D]

    Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    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

  12. Complications

    Time frame: Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

    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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Stryker Instruments

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2019
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.