Back to resultsConventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty
Primary Purpose
Osteoarthritis, Hip, Osteoarthritis, Surgery
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CO THA
Mako THA
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring total hip arthroplasty, total hip replacement, implant position, computerised tomography, makoplasty, robotic surgery
Eligibility Criteria
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
Sites / Locations
- UCL Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CO THA
Mako THA
Arm Description
Computerised tomography based planning of conventional total hip arthroplasty
Mako robotic-arm assisted total hip arthroplasty
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Operating time
Length of operating time in minutes
Blood loss
Estimated intraoperative blood loss in millilitres [ml]
Blood transfusion requirements
Units of blood required for transfusion intraoperatively; in whole units
Bone resection thickness
Thickness of bone resected during the surgical procedure in millimetres
Length of hospital stay
Length of patient hospital stay from admission to documented discharge; hours
Oxford hip score [OHS]
Patient recorded outcome measure via questionnaire. Scored 0-48 with 0 = poor score and 48 = best possible score
Harris Hip Score [HHS]
Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome
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
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
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
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
Full Information
NCT ID
NCT04095845
First Posted
July 17, 2019
Last Updated
June 27, 2023
Sponsor
University College, London
Collaborators
Stryker Instruments
1. Study Identification
Unique Protocol Identification Number
NCT04095845
Brief Title
Conventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Stryker Instruments
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteoarthritis, Surgery
Keywords
total hip arthroplasty, total hip replacement, implant position, computerised tomography, makoplasty, robotic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CO THA
Arm Type
Active Comparator
Arm Description
Computerised tomography based planning of conventional total hip arthroplasty
Arm Title
Mako THA
Arm Type
Experimental
Arm Description
Mako robotic-arm assisted total hip arthroplasty
Intervention Type
Device
Intervention Name(s)
CO THA
Intervention Description
Replacement of arthritic hip with artificial implant using CT-based navigation and conventional technique
Intervention Type
Device
Intervention Name(s)
Mako THA
Intervention Description
Replacement of arthritic hip with artificial implant using mako robotic-arm assist
Primary Outcome Measure Information:
Title
Reproducibility of the planned pre-operative centre of rotation [COR] of the hip
Description
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.
Time Frame
6 weeks post-op
Secondary Outcome Measure Information:
Title
Spinopelvic alignment
Description
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
Time Frame
Preoperatively and postoperatively at 6 months
Title
Operating time
Description
Length of operating time in minutes
Time Frame
Intraoperative
Title
Blood loss
Description
Estimated intraoperative blood loss in millilitres [ml]
Time Frame
Intraoperative
Title
Blood transfusion requirements
Description
Units of blood required for transfusion intraoperatively; in whole units
Time Frame
Intraoperative
Title
Bone resection thickness
Description
Thickness of bone resected during the surgical procedure in millimetres
Time Frame
Intraoperative
Title
Length of hospital stay
Description
Length of patient hospital stay from admission to documented discharge; hours
Time Frame
6 weeks post op
Title
Oxford hip score [OHS]
Description
Patient recorded outcome measure via questionnaire. Scored 0-48 with 0 = poor score and 48 = best possible score
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
Harris Hip Score [HHS]
Description
Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
Western Ontario and Mcmaster Universities Osteoarthritis Index [WOMAC]
Description
Patient recorded outcome measure via questionnaire. Questions regarding pain, stiffness and disability of affected hip joint. 0= best possible score
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
University of California at Los Angeles hip [UCLA]
Description
Patient recorded outcome measure via questionnaire. Score 0-10 with 10 being best possible outcome, 0 being worst possible outcome
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
European Quality of Life questionnaire with 5 dimensions for adults [EQ-5D]
Description
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
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
Complications
Description
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
Time Frame
Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fares S Haddad
Organizational Affiliation
UCL Hospital NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Babar Kayani
Organizational Affiliation
UCL Hospitals NHS Foundation TRust
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share IPD
Citations:
PubMed Identifier
32912292
Citation
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.
Results Reference
derived
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Conventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty
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