Arthroplasty, Replacement, HipNCT00293774
Alberta Hip Improvement Project
An observational study of Arthroplasty, Replacement, Hip, run by Alberta Bone and Joint Health Institute at 1 site in Canada.
Trial summary
A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- How many people
- 1,632 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2004to 16 Jul 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males between the ages of 18-65 and females between the ages of 18-55
Who may be able to join
- documentation of DJD of hip
- patient at least 18 years
- patient able to provide written consent
- Male under 65 years, female under 56 years
- Orthopedic surgeon has received appropriate training to implant an alternative device
Who cannot join
- renal failure (MOM only)
- child bearing potential (MOM only)
- inappropriate femoral anatomy, including evidence of osteoporosis
- inflammatory arthritis (MOM)
- Unwilling to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Provincial Initiative to Examine the Efficacy, Cost-effectiveness and Long-term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip
A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.
Read the detailed description
This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Prospective, Conventional therapy, Registry, Metal-on-metal, Ceramic-on-ceramic, Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Standard hip replacement subjects (polyethylene) | |
| Alternative Bearing | Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startJun 2004
- Primary completionJan 2011
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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
- 1,632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Bone and Joint Health Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James MacKenzie, M.D., Principal investigator, University of CalgaryGreg O'Connor, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293774
- Sponsor's protocol ID
- ABHIP-00001
- Status last verified
- Jul 2021
- First submitted
- 16 Feb 2006
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Provincial Initiative to Examine the Efficacy, Cost-effectiveness and Long-term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip
- ClinicalTrials.gov ID
- NCT00293774
- Acronym / sponsor ID
- ABHIP-00001
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Prospective, Conventional therapy, Registry, Metal-on-metal, Ceramic-on-ceramic, Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,632 participants (actual)
- Lead sponsor
- Alberta Bone and Joint Health InstituteUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 20 Feb 2006 (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.
A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.
Detailed description
This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | – | –Standard hip replacement subjects (polyethylene) |
| Alternative Bearing | – | –Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males between the ages of 18-65 and females between the ages of 18-55
Key inclusion criteria (5 listed)
- documentation of DJD of hip
- patient at least 18 years
- patient able to provide written consent
- Male under 65 years, female under 56 years
- Orthopedic surgeon has received appropriate training to implant an alternative device
Key exclusion criteria (5 listed)
- renal failure (MOM only)
- child bearing potential (MOM only)
- inappropriate femoral anatomy, including evidence of osteoporosis
- inflammatory arthritis (MOM)
- Unwilling to consent
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
Not reported in the source record.
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 28 Jul 2021.
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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.
James MacKenzie, M.D. principal investigator
University of Calgary
Greg O'Connor, MD principal investigator
University of Alberta
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 Arthroplasty, Replacement, Hip, run by Alberta Bone and Joint Health Institute 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 5 inclusion and 5 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 28 Jul 2021. 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.
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 28 Jul 2021.