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

NCT02162186 | Completed DMC

• 1 other identifier: CSP2013-12
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Hip; Congenital Hip Dysplasia; Avascular Necrosis

Keywords

Arthroplasty, Replacement, Hip/methods; Hip Joint/physiopathology; Hip Joint/radiography; Hip Joint/surgery; Hip Prosthesis; Outcome Assessment (Health Care); Female; Male; Adult

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Harris Hip Score (HHS)

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

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

• SF (Short Form)-12 Questionnaire

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

• UCLA (University of California, Los Angeles) Activity Level

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Corin: lead

Study Sites (1)

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Dislocation, Congenital; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Beaule, MD

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 14, 2020

Record last verified: 2018-11

Locations

CA (1)