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Not Yet Recruiting NCT07907185

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

Conditions: Osteo Arthritis Knee and Hip

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Hamilton Health Sciences Corporation

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.

Eligibility Criteria

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 informed consent and complete protocol-defined study assessments. 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 informed consent.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07907185). StuddyBuddy aggregates publicly available trial information.