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

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

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.

Study Overview

• Status: Completed
• Conditions: Avascular Necrosis; Congenital Hip Dysplasia; Osteoarthritis of Hip

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
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital - General Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femoral Stem Migration Radiographic Assessment	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 weeks to end of study (approximately 2 years) post-operatively
Rate of Implant Failure	The number of revisions will be recorded.	2 weeks to end of study (approximately 2 years) post-operatively
Radiographic Assessment of Wear in the Acetabular Components	Anterior-posterior (AP) and lateral radiographs from each follow-up visit will be used to assess wear of the acetabular (hip) components.	2 weeks to end of study (approximately 2 years) post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS)	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 weeks to end of study (approximately 2 years) post-operatively
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	A standardized set of questions and measurements to assess the function of the hip. It includes pain, stiffness, and joint function.	2 weeks to end of study (approximately 2 years) post-operatively
SF (Short Form)-12 Questionnaire	A subject-completed questionnaire with questions and he/she's health and well-being.	2 weeks to end of study (approximately 2 years) post-operatively
UCLA (University of California, Los Angeles) Activity Level	A subject-completed questionnaire which asks his/her current activity level.	2 weeks to end of study (approximately 2 years) post-operatively

Collaborators and Investigators

• Sponsor: Corin

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Adult; Female; Male; Hip Prosthesis; Outcome Assessment (Health Care); Arthroplasty, Replacement, Hip/methods; Hip Joint/physiopathology; Hip Joint/radiography; Hip Joint/surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteoarthritis, Hip
• Other Study ID Numbers: CSP2013-12