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

Sponsor

University College, London (Other)

Overall Status

Recruiting

CT.gov ID

NCT04095845

Collaborator

Stryker Instruments (Industry)

Enrollment

Location

Arms

49.7

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip Osteoarthritis Surgery	Device: CO THA Device: Mako THA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 9, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reproducibility of the planned pre-operative centre of rotation [COR] of the hip [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 Outcome Measures

Spinopelvic alignment [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
Operating time [Intraoperative]
Length of operating time in minutes
Blood loss [Intraoperative]
Estimated intraoperative blood loss in millilitres [ml]
Blood transfusion requirements [Intraoperative]
Units of blood required for transfusion intraoperatively; in whole units
Bone resection thickness [Intraoperative]
Thickness of bone resected during the surgical procedure in millimetres
Length of hospital stay [6 weeks post op]
Length of patient hospital stay from admission to documented discharge; hours
Oxford hip score [OHS] [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
Harris Hip Score [HHS] [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
Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC] [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
University of California at Los Angeles hip [UCLA] [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
European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D] [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
Complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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