Hip DislocationNCT00175500
Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation
A study testing Large Diameter Femoral Head in people with Hip Dislocation, run by University of British Columbia at 1 site in Canada.
Trial summary
About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hip Dislocation
- What is being tested?
- Large Diameter Femoral Head
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.
- Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.
- The acetabular component must have a minimum outer diameter of 50 mm.
- The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)
- Patients must be able to reply to questionnaires in either French or English.
Who cannot join
- Patients who are undergoing revision for recurrent dislocation.
- Revision of the acetabulum requiring structural allograft or reconstruction ring.
- Revision of the acetabulum requiring the use of cemented all-polyethylene cups.
- Revision of the acetabulum using a liner cemented into an existing metal shell.
- Intra-operative decision to use a constrained liner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Multi-Centre Controlled Trial of Large Diameter (36/40 mm) Versus Conventional Diameter (32 mm) Femoral Heads for the Prevention of Post Revision Arthroplasty Dislocation
About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.
- Conditions
- Hip Dislocation
- Being tested
- Large Diameter Femoral Head
- Keywords
- Post-Arthroplasty Hip Dislocation
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Diameter Femoral HeadDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty
Measured: at two years
Secondary outcomes (4)
To compare polyethylene wear in the two groups
To compare the difference in functional and quality of life measures in the two groups
Measured: at 3, 12 and 24 months post surgery
To compare radiographic findings in the two groups
To estimate the rate of re-revision in the two groups
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 completionApr 2009
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DislocationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
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
- NCT00175500
- Sponsor's protocol ID
- C02-0530
- Status last verified
- Sep 2011
- First submitted
- 11 Sep 2005
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multi-Centre Controlled Trial of Large Diameter (36/40 mm) Versus Conventional Diameter (32 mm) Femoral Heads for the Prevention of Post Revision Arthroplasty Dislocation
- ClinicalTrials.gov ID
- NCT00175500
- Acronym / sponsor ID
- C02-0530
- Conditions
- Hip Dislocation
- Keywords
- Post-Arthroplasty Hip Dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2012 (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.
About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.
- Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.
- The acetabular component must have a minimum outer diameter of 50 mm.
- The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)
- Patients must be able to reply to questionnaires in either French or English.
Key exclusion criteria (5 listed)
- Patients who are undergoing revision for recurrent dislocation.
- Revision of the acetabulum requiring structural allograft or reconstruction ring.
- Revision of the acetabulum requiring the use of cemented all-polyethylene cups.
- Revision of the acetabulum using a liner cemented into an existing metal shell.
- Intra-operative decision to use a constrained liner.
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 |
|---|---|---|
| Large Diameter Femoral Head | Device | – |
Primary outcome
To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty
Time frame: at two years
4 secondary outcomes
To compare polyethylene wear in the two groups
To compare the difference in functional and quality of life measures in the two groups
Time frame: at 3, 12 and 24 months post surgery
To compare radiographic findings in the two groups
To estimate the rate of re-revision in the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
Related trials for Hip Dislocation
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
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 Large Diameter Femoral Head in people with Hip Dislocation, 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 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: status not confirmed, as of the sponsor's last update on 22 Sep 2011. 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 compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty (time frame: at two 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 22 Sep 2011.