Osteo Arthritis Knee and HipTHRIVENCT07907185
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
A study testing MAKO Robotic System (Stryker, USA) and Conventional Total Hip Arthroplasty in people with Osteo Arthritis Knee and Hip, run by Hamilton Health Sciences Corporation.
Trial summary
Hip replacement is highly effective for severe osteoarthritis, but some patients continue to experience symptoms or complications. Robotic-assisted hip replacement uses three-dimensional planning and robotic guidance to position implants more precisely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee and Hip
- What is being tested?
- MAKO Robotic System (Stryker, USA) and Conventional Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at the time of enrolment.
- Scheduled to undergo primary, elective THA for a diagnosis of primary osteoarthritis.
- Considered by the treating surgeon to be clinically suitable for either RA-THA or CO-THA.
- Willing and able to provide written informed consent and complete protocol-defined study assessments.
Who cannot join
- THA indicated for a diagnosis other than primary osteoarthritis, including inflammatory arthritis, post-traumatic arthritis, avascular necrosis, hip dysplasia, or femoral neck fracture.
- History of any prior surgery of the index hip joint.
- Complex primary THA, including anatomical or reconstructive considerations that, in the opinion of the treating surgeon, would render the participant unsuitable for either randomized intervention.
- Active or prior infection involving the index hip that, in the opinion of the treating surgeon, would affect suitability for primary elective THA.
- Simultaneous bilateral THA or a planned staged contralateral THA before completion of the 6-month primary outcome assessment.
- Previous randomization in the present trial.
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- Current participation in another study that does not permit co-enrolment or that, in the opinion of the Investigator, would interfere with participation in this trial.
- Any medical condition, cognitive impairment, or other circumstance that, in the opinion of the Investigator, would interfere with the participant's ability to complete protocol-defined assessments or follow-up.
- Unable to complete the required study questionnaires in English or unable to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Hip replacement is highly effective for severe osteoarthritis, but some patients continue to experience symptoms or complications. Robotic-assisted hip replacement uses three-dimensional planning and robotic guidance to position implants more precisely. Although its use is increasing, it remains uncertain whether this added precision improves recovery or outcomes that patients can feel.
We will conduct an internal pilot randomized trial of adults undergoing hip replacement at Juravinski Hospital. Participants will be assigned by chance to robotic-assisted or conventional surgery. The pilot will assess recruitment, delivery of assigned surgery, protocol adherence, follow-up and data quality to determine whether a larger Canadian multicentre trial is feasible. We will also collect joint awareness, function, quality of life, satisfaction, complications, operating time, length of stay and readmission. If progression criteria are met, pilot participants and data will be retained in the expanded trial. This study will build the Canadian evidence needed to evaluate robotic-assisted hip replacement responsibly.
- Conditions
- Osteo Arthritis Knee and Hip
- Being tested
- MAKO Robotic System (Stryker, USA), Conventional Total Hip Arthroplasty
- Keywords
- Arthroplasty, Robotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAKO Robotic System (Stryker, USA)Procedure or surgery
Also called Conventional Total Hip Arthroplasty
Stryker MAKO Robotic System using Stryker Implants
Conventional Total Hip ArthroplastyProcedure or surgery
Conventional Total Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted total hip arthroplasty | Active comparator | MAKO Robotic System (Stryker, USA) Receives: Procedure: MAKO Robotic System (Stryker, USA) |
| Conventional Total Hip Arthroplasty | Active comparator | Conventional Total Hip Arthroplasty Receives: Procedure: Conventional Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcomes
Recruitment, allocated intervention, and protocol adherence, completion of follow-up among those due, and key data completeness.
Measured: 6 months
Secondary outcomes (6)
Forgotten Joint Score-12 (FJS-12)
Awareness of the operated hip during everyday activities will be assessed using the 12-item Forgotten Joint Score. Responses are converted to a total score ranging from 0 to 100. Higher scores indicate less awareness of the artificial joint and a better outcome.
Measured: 6 weeks and 6 months after surgery.
Oxford Hip Score (OHS)
Hip pain and function will be assessed using the Oxford Hip Score, a 12-item patient-reported questionnaire. Item scores are summed to produce a total score ranging from 0 to 48. Higher scores indicate less pain and better hip function.
Measured: 6 weeks and 6 months after surgery.
Euro-Qol 5 Dimensions (EQ-5D)
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire. It assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, coded from 1 (no problems) to 5 (extreme problems or inability to perform the activity). Higher levels indicate worse health within that dimension.
Measured: 6 weeks and 6 months after surgery.
Patient Satisfaction With Hip Replacement
Overall satisfaction with the operated hip will be assessed using five response categories: very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, or very dissatisfied. The number and percentage of participants in each category will be reported.
Measured: 6 weeks and 6 months after surgery.
Surgical Complications
Prespecified complications include intraoperative or postoperative periprosthetic fracture, superficial or deep surgical site infection, prosthetic dislocation, implant failure or aseptic loosening, and reoperation. Other clinically important surgical complications will also be recorded.
Measured: 6 weeks and 6 months after surgery.
Safety Outcomes
Any adverse or serious adverse events will be collected where applicable for trial monitoring.
Measured: 6 weeks and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis Knee and HipStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Wood, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907185
- Sponsor's protocol ID
- THRIVE-2026
- Acronym
- THRIVE
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
- ClinicalTrials.gov ID
- NCT07907185
- Acronym / sponsor ID
- THRIVE / THRIVE-2026
- Conditions
- Osteo Arthritis Knee and Hip
- Keywords
- Arthroplasty, Robotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 30 Oct 2026 (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.
Hip replacement is highly effective for severe osteoarthritis, but some patients continue to experience symptoms or complications. Robotic-assisted hip replacement uses three-dimensional planning and robotic guidance to position implants more precisely. Although its use is increasing, it remains uncertain whether this added precision improves recovery or outcomes that patients can feel.
We will conduct an internal pilot randomized trial of adults undergoing hip replacement at Juravinski Hospital. Participants will be assigned by chance to robotic-assisted or conventional surgery. The pilot will assess recruitment, delivery of assigned surgery, protocol adherence, follow-up and data quality to determine whether a larger Canadian multicentre trial is feasible. We will also collect joint awareness, function, quality of life, satisfaction, complications, operating time, length of stay and readmission. If progression criteria are met, pilot participants and data will be retained in the expanded trial. This study will build the Canadian evidence needed to evaluate robotic-assisted hip replacement responsibly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted total hip arthroplasty | Active comparator | Procedure: MAKO Robotic System (Stryker, USA)MAKO Robotic System (Stryker, USA) |
| Conventional Total Hip Arthroplasty | Active comparator | Procedure: Conventional Total Hip ArthroplastyConventional Total Hip Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older at the time of enrolment.
- Scheduled to undergo primary, elective THA for a diagnosis of primary osteoarthritis.
- Considered by the treating surgeon to be clinically suitable for either RA-THA or CO-THA.
- Willing and able to provide written informed consent and complete protocol-defined study assessments.
Key exclusion criteria (9 listed)
- THA indicated for a diagnosis other than primary osteoarthritis, including inflammatory arthritis, post-traumatic arthritis, avascular necrosis, hip dysplasia, or femoral neck fracture.
- History of any prior surgery of the index hip joint.
- Complex primary THA, including anatomical or reconstructive considerations that, in the opinion of the treating surgeon, would render the participant unsuitable for either randomized intervention.
- Active or prior infection involving the index hip that, in the opinion of the treating surgeon, would affect suitability for primary elective THA.
- Simultaneous bilateral THA or a planned staged contralateral THA before completion of the 6-month primary outcome assessment.
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 |
|---|---|---|
| MAKO Robotic System (Stryker, USA)Also: Conventional Total Hip ArthroplastyStryker MAKO Robotic System using Stryker Implants | Procedure or surgery | Robotic assisted total hip arthroplasty |
| Conventional Total Hip ArthroplastyConventional Total Hip Arthroplasty | Procedure or surgery | Conventional Total Hip Arthroplasty |
Primary outcome
Feasibility Outcomes
Time frame: 6 months
Recruitment, allocated intervention, and protocol adherence, completion of follow-up among those due, and key data completeness.
6 secondary outcomes
Forgotten Joint Score-12 (FJS-12)
Time frame: 6 weeks and 6 months after surgery.
Oxford Hip Score (OHS)
Time frame: 6 weeks and 6 months after surgery.
Euro-Qol 5 Dimensions (EQ-5D)
Time frame: 6 weeks and 6 months after surgery.
Patient Satisfaction With Hip Replacement
Time frame: 6 weeks and 6 months after surgery.
Surgical Complications
Time frame: 6 weeks and 6 months after surgery.
Safety Outcomes
Time frame: 6 weeks and 6 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Wood principal investigator
Hamilton Health Sciences Corporation
Questions about this trial
What is this clinical trial studying?
A study testing MAKO Robotic System (Stryker, USA) and Conventional Total Hip Arthroplasty in people with Osteo Arthritis Knee and Hip, run by Hamilton Health Sciences Corporation.
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 4 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meera Karunakaran (905-521-2100 ext. 43814, karunakarm@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.