Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
NCT Number: NCT02162186
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.
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Observational
Ottawa, Ontario, K1H 8L6, Canada
The present study will prospectively recruit 100 patients scheduled for elective total hip replacement with Corin's TriFIT Hip System at the Ottawa Hospital - General Campus. As part of their clinical care, patients routinely undergo a clinical examination and have had radiographs taken at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery. Using specialized software, radiographs from each interval will be examined to assess femoral stem migration and joint wear patterns. Femoral stem migration will be assessed using computer-assisted software. The study will also assess the rate of implant failure during the first two post-operative years. Clinical assessments and questionnaires will also be completed during each of the follow-up intervals.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
Femoral stem migration (in millimeters (mm)) will be assessed using computer-assisted Einzel Bild Roentgen Analyze-Femoral Component Analysis (EBRA-FCA) software and radiographs taken at each interval.
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
The number of revisions will be recorded.
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
Anterior-posterior (AP) and lateral radiographs from each follow-up visit will be used to assess wear of the acetabular (hip) components.
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
A standardized set of questions and measurements to assess the function of the hip. It includes pain, function, range of motion (ROM), and absence of deformity.
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
A standardized set of questions and measurements to assess the function of the hip. It includes pain, stiffness, and joint function.
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
A subject-completed questionnaire with questions and he/she's health and well-being.
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
A subject-completed questionnaire which asks his/her current activity level.
Corin
Industry
Analysis of Clinical Outcome and Implant Migration of the Cementless Tri-Fit Total Hip Replacement System
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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