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

Avascular Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162186
• Other study ID #: CSP2013-12
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Avascular Necrosis
• Congenital Hip Dysplasia
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis of Hip
• Osteoarthritis, Hip

Locations

Country	Name	City	State
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of Implant Failure	The number of revisions will be recorded.	2 weeks to end of study (approximately 2 years) post-operatively
Primary	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	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
Secondary	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
Secondary	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
Secondary	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