OsteoarthritisNCT00175487
Comparison of Hip Resurfacing to Large Femoral Head Total Hip Arthroplasty
A study testing Hip replacement in people with Osteoarthritis and Avascular Necrosis, run by University of British Columbia at 1 site in Canada.
Trial summary
This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis
- What is being tested?
- Hip replacement
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Jun 2014
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for hip resurfacing because of osteoarthritis or avascular necrosis
- Aged 19 to 65 years old
- Ability to give informed consent
Who cannot join
- Previous fracture requiring internal fixation of the hip
- Previous hip osteotomy (pelvic or femoral)
- Dysplasia requiring structural bone graft
- Inability to respond to questionnaires in English (or French, Montreal centre only)
- The presence of osteopenia or osteoporosis
- Evidence of hepatic/renal insufficiency or failure from medical history or laboratory assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial
This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
- Conditions
- Osteoarthritis, Avascular Necrosis
- Being tested
- Hip replacement
- Keywords
- Osteoarthritis/Avascular Necrosis, Hip
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip replacementProcedure or surgery
Also called Durom Total Hip System
This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the difference in postoperative quality of life between patients with Durom® hip resurfacing versus those with total hip arthroplasty (THA) using a large-head, metal-on-metal articulation
Measured: at 2 years
Secondary outcomes (3)
To estimate the difference in concentrations of cobalt and chromium ions in serum
To estimate the difference in gait (pelvic tilt, forward velocity, and cadence)
Measured: at 12 and 52 weeks
To estimate the lower limb functional instability by a test of postural balance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald Garbuz, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175487
- Sponsor's protocol ID
- H05-70105
- Other IDs
- C05-0105
- Status last verified
- Mar 2014
- First submitted
- 11 Sep 2005
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Head Resurfacing Versus a Large Femoral Head (Durom®) Total Hip System: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00175487
- Acronym / sponsor ID
- H05-70105
- Conditions
- Osteoarthritis, Avascular Necrosis
- Keywords
- Osteoarthritis/Avascular Necrosis, Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 15 Sep 2005 (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.
This study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for hip resurfacing because of osteoarthritis or avascular necrosis
- Aged 19 to 65 years old
- Ability to give informed consent
Key exclusion criteria (6 listed)
- Previous fracture requiring internal fixation of the hip
- Previous hip osteotomy (pelvic or femoral)
- Dysplasia requiring structural bone graft
- Inability to respond to questionnaires in English (or French, Montreal centre only)
- The presence of osteopenia or osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip replacementAlso: Durom Total Hip SystemThis study evaluates femoral head resurfacing versus a large femoral head (Durom®) total hip system. This is a prospective randomized trial. | Procedure or surgery | – |
Primary outcome
To estimate the difference in postoperative quality of life between patients with Durom® hip resurfacing versus those with total hip arthroplasty (THA) using a large-head, metal-on-metal articulation
Time frame: at 2 years
3 secondary outcomes
To estimate the difference in concentrations of cobalt and chromium ions in serum
To estimate the difference in gait (pelvic tilt, forward velocity, and cadence)
Time frame: at 12 and 52 weeks
To estimate the lower limb functional instability by a test of postural balance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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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.
Donald Garbuz, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip replacement in people with Osteoarthritis and Avascular Necrosis, run by University of British Columbia 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: status not confirmed, as of the sponsor's last update on 18 Mar 2014. 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?
Results are not available in the source record.
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?
To estimate the difference in postoperative quality of life between patients with Durom® hip resurfacing versus those with total hip arthroplasty (THA) using a large-head, metal-on-metal articulation (time frame: at 2 years). 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 18 Mar 2014.