Osteoarthritis, HipNCT04095845
Conventional Total Hip Arthroplasty vs Mako Robotic-arm Assisted Total Hip Arthroplasty
A study testing CO THA and Mako THA in people with Osteoarthritis, Hip and Osteoarthritis, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Surgery
- What is being tested?
- CO THA and Mako THA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2018to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CO THA, Mako THA
- Keywords
- total hip arthroplasty, total hip replacement, implant position, computerised tomography, makoplasty, robotic surgery
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO THADevice
Replacement of arthritic hip with artificial implant using CT-based navigation and conventional technique
Mako THADevice
Replacement of arthritic hip with artificial implant using mako robotic-arm assist
| Study group | Role | What they receive |
|---|---|---|
| CO THA | Active comparator | Computerised tomography based planning of conventional total hip arthroplasty Receives: Device: CO THA |
| Mako THA | Experimental | Mako robotic-arm assisted total hip arthroplasty Receives: Device: Mako THA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post-op
Secondary outcomes (12)
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
Measured: Preoperatively and postoperatively at 6 months
Operating time
Length of operating time in minutes
Measured: Intraoperative
Blood loss
Estimated intraoperative blood loss in millilitres [ml]
Measured: Intraoperative
Blood transfusion requirements
Units of blood required for transfusion intraoperatively; in whole units
Measured: Intraoperative
Bone resection thickness
Thickness of bone resected during the surgical procedure in millimetres
Measured: Intraoperative
Length of hospital stay
Length of patient hospital stay from admission to documented discharge; hours
Measured: 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
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Harris Hip Score [HHS]
Patient recorded outcome measure via questionnaire. Scored 0-100 with 100 best possible outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start9 Nov 2018
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Sponsor
- Investigators
- Fares S Haddad, Study chair, UCL Hospital NHS Foundation TrustBabar Kayani, Principal investigator, UCL Hospitals NHS Foundation TRust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095845
- Sponsor's protocol ID
- 17/0766
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2019
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plans to share IPD
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.
PubMed 32912292
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04095845
- Acronym / sponsor ID
- 17/0766
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Surgery
- Keywords
- total hip arthroplasty, total hip replacement, implant position, computerised tomography, makoplasty, robotic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO THA | Active comparator | Device: CO THAComputerised tomography based planning of conventional total hip arthroplasty |
| Mako THA | Experimental | Device: Mako THAMako robotic-arm assisted total hip arthroplasty |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has hip osteoarthritis requiring primary THA
Key exclusion criteria (9 listed)
- Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO THAReplacement of arthritic hip with artificial implant using CT-based navigation and conventional technique | Device | CO THA |
| Mako THAReplacement of arthritic hip with artificial implant using mako robotic-arm assist | Device | Mako THA |
Primary outcome
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.
12 secondary outcomes
Spinopelvic alignment
Time frame: Preoperatively and postoperatively at 6 months
Operating time
Time frame: Intraoperative
Blood loss
Time frame: Intraoperative
Blood transfusion requirements
Time frame: Intraoperative
Bone resection thickness
Time frame: Intraoperative
Length of hospital stay
Time frame: 6 weeks post op
Oxford hip score [OHS]
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Harris Hip Score [HHS]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Complications
Time frame: Intraoperative; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 32912292Kayani 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.
- Individual participant dataSharing planned: No. No plans to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fares S Haddad study chair
UCL Hospital NHS Foundation Trust
Babar Kayani principal investigator
UCL Hospitals NHS Foundation TRust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO THA and Mako THA in people with Osteoarthritis, Hip and Osteoarthritis, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of the planned pre-operative centre of rotation [COR] of the hip (time frame: 6 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.