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

NCT04095845 | Completed FDA Device

• 1 other identifier: 17/0766
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Hip; Osteoarthritis; Surgery

Keywords

total hip arthroplasty; total hip replacement; implant position; computerised tomography; makoplasty; robotic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Spinopelvic alignment

  Preoperatively and postoperatively at 6 months

• Operating time

  Intraoperative

• Blood loss

  Intraoperative

• Blood transfusion requirements

  Intraoperative

• Bone resection thickness

  Intraoperative

Study Arms (2)

CO THA

ACTIVE COMPARATOR

Computerised tomography based planning of conventional total hip arthroplasty

Device: CO THA

Mako THA

EXPERIMENTAL

Mako robotic-arm assisted total hip arthroplasty

Device: Mako THA

Interventions

CO THA DEVICE

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

CO THA

Mako THA DEVICE

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

Mako THA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Stryker Instruments: collaborator

Study Sites (1)

UCL Hospital NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Related Publications (1)

• Kayani B, Konan S, Tahmassebi J, Ayuob A, Haddad FS. Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty: study protocol for a prospective randomised controlled trial. Trials. 2020 Sep 10;21(1):776. doi: 10.1186/s13063-020-04702-7.

  PMID: 32912292 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Fares S Haddad

  UCL Hospital NHS Foundation Trust

  STUDY CHAIR

• Babar Kayani

  UCL Hospitals NHS Foundation TRust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: September 19, 2019
• Study Start: November 9, 2018
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)