Osteoarthritis of HipNCT02162186
Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement
An observational study of Osteoarthritis of Hip and Congenital Hip Dysplasia, run by Corin at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis of Hip, Congenital Hip Dysplasia, Avascular Necrosis
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Arthroplasty, Replacement, Hip/methods, Hip Joint/physiopathology, Hip Joint/radiography, Hip Joint/surgery, Hip Prosthesis, Outcome Assessment (Health Care), Female, Male, Adult
- Medical subject headings
- Osteoarthritis, Hip, Hip Dislocation, Congenital, Osteonecrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks to end of study (approximately 2 years) post-operatively
Rate of Implant Failure
The number of revisions will be recorded.
Measured: 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.
Measured: 2 weeks to end of study (approximately 2 years) post-operatively
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks to end of study (approximately 2 years) post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Beaule, MD, Principal investigator, Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162186
- Sponsor's protocol ID
- CSP2013-12
- Status last verified
- Nov 2018
- First submitted
- 10 Jun 2014
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Outcome and Implant Migration of the Cementless Tri-Fit Total Hip Replacement System
- ClinicalTrials.gov ID
- NCT02162186
- Acronym / sponsor ID
- CSP2013-12
- Keywords
- Arthroplasty, Replacement, Hip/methods, Hip Joint/physiopathology, Hip Joint/radiography, Hip Joint/surgery, Hip Prosthesis, Outcome Assessment (Health Care), Female, Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Rate of Implant Failure
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
The number of revisions will be recorded.
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.
4 secondary outcomes
Harris Hip Score (HHS)
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
SF (Short Form)-12 Questionnaire
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
UCLA (University of California, Los Angeles) Activity Level
Time frame: 2 weeks to end of study (approximately 2 years) post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
Related trials for Osteoarthritis of Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Beaule, MD principal investigator
Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of Hip and Congenital Hip Dysplasia, run by Corin at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral Stem Migration Radiographic Assessment (time frame: 2 weeks to end of study (approximately 2 years) post-operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.