CompletedNot Applicable

Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement

Canada37 participantsStarted 2014-10

Plain-language summary

The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients scheduled for primary, unilateral total hip replacement (THR) with no previous history of hip replacement and/or fracture surgery. * Patients with arthritis secondary Noninflammatory Degenerative Joint Diseases (NIDJD), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis. * Patients who do not meet any of the exclusion criteria. Exclusion Criteria: * Patients with previous fusions, acute femoral neck fractures, above knee amputations, or previous total knee replacement. * Patients who had previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device. * Patients with neuropathic joints. * Patients who required structural bone grafts. * Patients with an ipsilateral girdlestone. * Patients who otherwise met the study criteria, but for which appropriate clinical follow-up data is not available (i.e. patients deceased prior to 2-year follow-up, patients refused to return for follow-up).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Femoral Stem Migration Radiographic Assessment

Timeframe: 2 weeks to end of study (approximately 2 years) post-operatively

Rate of Implant Failure

Timeframe: 2 weeks to end of study (approximately 2 years) post-operatively

Radiographic Assessment of Wear in the Acetabular Components

Timeframe: 2 weeks to end of study (approximately 2 years) post-operatively

Trial details

NCT IDNCT02162186

SponsorCorin

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Osteoarthritis of Hip trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Femoral Stem Migration Radiographic Assessment

Timeframe: 2 weeks to end of study (approximately 2 years) post-operatively

Rate of Implant Failure

Timeframe: 2 weeks to end of study (approximately 2 years) post-operatively

Radiographic Assessment of Wear in the Acetabular Components

Timeframe: 2 weeks to end of study (approximately 2 years) post-operatively