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

A Prospective Randomised Controlled Trial Comparing Computerised Tomography Based Planning of Conventional Total Hip Arthroplasty Versus 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Surgery; Osteoarthritis, Hip
• Intervention / Treatment: Device: CO THA; Device: Mako THA

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • UCL Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CO THA; Computerised tomography based planning of conventional total hip arthroplasty	Device: CO THA; Replacement of arthritic hip with artificial implant using CT-based navigation and conventional technique
Experimental: Mako THA; Mako robotic-arm assisted total hip arthroplasty	Device: Mako THA; Replacement of arthritic hip with artificial implant using mako robotic-arm assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score [HHS]	Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Spinopelvic alignment	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	Preoperatively and postoperatively at 6 months
Operating time	Length of operating time in minutes	Intraoperative
Blood loss	Estimated intraoperative blood loss in millilitres [ml]	Intraoperative
Blood transfusion requirements	Units of blood required for transfusion intraoperatively; in whole units	Intraoperative
Bone resection thickness	Thickness of bone resected during the surgical procedure in millimetres	Intraoperative
Length of hospital stay	Length of patient hospital stay from admission to documented discharge; hours	6 weeks post op
Oxford hip score [OHS]	Patient recorded outcome measure via questionnaire. Scored 0-48 with 0 = poor score and 48 = best possible score	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC]	Patient recorded outcome measure via questionnaire. Questions regarding pain, stiffness and disability of affected hip joint. 0= best possible score	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
University of California at Los Angeles hip [UCLA]	Patient recorded outcome measure via questionnaire. Score 0-10 with 10 being best possible outcome, 0 being worst possible outcome	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D]	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	Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Complications	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	Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Stryker Instruments
• Investigators: Study Chair: Fares S Haddad, UCL Hospital NHS Foundation Trust; Principal Investigator: Babar Kayani, UCL Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: total hip arthroplasty; total hip replacement; robotic surgery; makoplasty; implant position; computerised tomography
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Tacrine
• Other Study ID Numbers: 17/0766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes