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

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ClinicalTrials.gov Identifier: NCT02162186
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Corin

Brief 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.

Condition or disease
Osteoarthritis of Hip Congenital Hip Dysplasia Avascular Necrosis

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Clinical Outcome and Implant Migration of the Cementless Tri-Fit Total Hip Replacement System
Study Start Date : October 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The first 100 patients Dr. Paul Beaule undergoing a total hip replacement with Corin's TriFIT Total Hip replacement system that meet the eligibility requirements and consent to do the study.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162186


Contacts
Contact: Paul Beaule, MD (613) 737-8899 ext 73265 pbeaule@ottawahospital.on.ca

Locations
Canada, Ontario
Ottawa Hospital - General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Paul Beaule, MD    (613) 737-8899 ext 73265    pbeaule@ottawahospital.on.ca   
Principal Investigator: Paul Beaule, MD         
Sponsors and Collaborators
Corin
Investigators
Principal Investigator: Paul Beaule, MD Ottawa Hospital

Responsible Party: Corin
ClinicalTrials.gov Identifier: NCT02162186     History of Changes
Other Study ID Numbers: CSP2013-12
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Corin:
Arthroplasty, Replacement, Hip/methods
Hip Joint/physiopathology
Hip Joint/radiography
Hip Joint/surgery
Hip Prosthesis
Outcome Assessment (Health Care)
Female
Male
Adult

Additional relevant MeSH terms:
Osteoarthritis
Necrosis
Hip Dislocation
Hip Dislocation, Congenital
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Joint Dislocations
Bone Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities