ClinicalTrials.gg
Not yet recruitingNCT07907185THRIVEUpdated Oct 30, 2026

Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs

An interventional study of MAKO Robotic System (Stryker, USA) and Conventional Total Hip Arthroplasty in Osteo Arthritis Knee and Hip, sponsored by Hamilton Health Sciences Corporation. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Treatment

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Osteo Arthritis Knee and Hip

Keywords

  • Arthroplasty
  • Robotics
03

In context

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years or older at the time of enrolment.
  2. Scheduled to undergo primary, elective THA for a diagnosis of primary osteoarthritis.
  3. Considered by the treating surgeon to be clinically suitable for either RA-THA or CO-THA.
  4. Willing and able to provide written and complete protocol-defined study assessments.

Exclusion criteria

Exclusion Criteria:

  1. THA indicated for a diagnosis other than primary osteoarthritis, including inflammatory arthritis, post-traumatic arthritis, avascular necrosis, hip dysplasia, or femoral neck fracture.
  2. History of any prior surgery of the index hip joint.
  3. 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.
  4. Active or prior infection involving the index hip that, in the opinion of the treating surgeon, would affect suitability for primary elective THA.
  5. Simultaneous bilateral THA or a planned staged contralateral THA before completion of the 6-month primary outcome assessment.
  6. Previous randomization in the present trial.
  7. 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.
  8. 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.
  9. Unable to complete the required study questionnaires in English or unable to provide .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Robotic assisted total hip arthroplasty

    MAKO Robotic System (Stryker, USA)

    Procedure: MAKO Robotic System (Stryker, USA)

  • Active comparator
    Conventional Total Hip Arthroplasty

    Conventional Total Hip Arthroplasty

    Procedure: Conventional Total Hip Arthroplasty

Interventions

  • ProcedureMAKO Robotic System (Stryker, USA)

    Stryker MAKO Robotic System using Stryker Implants

    Also known as: Conventional Total Hip Arthroplasty

  • ProcedureConventional Total Hip Arthroplasty

    Conventional Total Hip Arthroplasty

06

What researchers measure

Primary outcomes

  1. Feasibility Outcomes

    Recruitment, allocated intervention, and protocol adherence, completion of follow-up among those due, and key data completeness.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 weeks and 6 months after surgery.

  2. 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.

    Time frame: 6 weeks and 6 months after surgery.

  3. 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.

    Time frame: 6 weeks and 6 months after surgery.

  4. 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.

    Time frame: 6 weeks and 6 months after surgery.

  5. 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.

    Time frame: 6 weeks and 6 months after surgery.

  6. Safety Outcomes

    Any adverse or serious adverse events will be collected where applicable for trial monitoring.

    Time frame: 6 weeks and 6 months after surgery.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907185
Responsible party
Sponsor
First posted
Oct 30, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Meera Karunakaran
Contact
karunakarm@hhsc.ca
905-521-2100 ext. 43814
Thomas Wood
principal investigator · Hamilton Health Sciences Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion