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Completed

NCT Number: NCT02162186

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Femoral Stem Migration Radiographic Assessment

    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.

  2. Rate of Implant Failure

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

    The number of revisions will be recorded.

  3. Radiographic Assessment of Wear in the Acetabular Components

    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.

Secondary outcomes

  1. Harris Hip Score (HHS)

    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.

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    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.

  3. SF (Short Form)-12 Questionnaire

    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.

  4. UCLA (University of California, Los Angeles) Activity Level

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

    A subject-completed questionnaire which asks his/her current activity level.

Sponsors and collaborators

Lead sponsor

Corin

Industry

Registry information

Official study title

Analysis of Clinical Outcome and Implant Migration of the Cementless Tri-Fit Total Hip Replacement System

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2014
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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