Hip DysplasiaNCT01575977
Stress Analysis of Hip Dysplasia
An observational study of Hip Dysplasia, run by University of Utah.
Trial summary
The main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (PAO). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hip Dysplasia
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Aug 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: 18-40 years old
Who may be able to join
- Patients aged 18-40 years
- Patients who have undergone periacetabular osteotomy by Dr. Peters for treatment of hip dysplasia.
- Patients who have previously participated in IRB #10983 "Comparative Stress Analysis of Hip Dysplasia".
Who cannot join
- Persons with a history of allergies to lidocaine or seafood.
- Children under the age of 18.
- Persons incarcerated, on trial, or parole.
- Women who are pregnant.
- Subjects who do not have high quality pre-operative images available or have not been surgically treated by periacetabular osteotomy.
About this study
Official title: Stress Analysis of Hip Dysplasia After Corrective Surgery
The main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (PAO).
Read the detailed description
PAO was designed as a joint preserving surgical procedure to compensate for a shallow acetabulum by re-orienting the acetabulum into a position that provides better coverage of the femoral head. Although the overall theory that increasing load bearing area (improving coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony surface may not behave in this manner. It is possible that joint stress may increase when the acetabulum is reoriented into a position that increases load bearing area if post-operative joint congruency is worse than pre-operative.
- Conditions
- Hip Dysplasia
- Medical subject headings
- Hip Dislocation
What is being measured
The primary outcome is the main question the study is designed to answer.
To predict cartilage contact pressures in the hip joint during simulated daily activities before and after periacetabular osteotomy (PAO) for correction of traditional dysplasia/retroversion.
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Anderson, University of Utah
- Investigators
- Andrew Anderson, Principal investigator, Orthopedic Surgery Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575977
- Sponsor's protocol ID
- 43600
- Status last verified
- Oct 2019
- First submitted
- 6 Mar 2012
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Analysis of Hip Dysplasia After Corrective Surgery
- ClinicalTrials.gov ID
- NCT01575977
- Acronym / sponsor ID
- 43600
- Conditions
- Hip Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 12 Apr 2012 (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 main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (PAO).
Detailed description
PAO was designed as a joint preserving surgical procedure to compensate for a shallow acetabulum by re-orienting the acetabulum into a position that provides better coverage of the femoral head. Although the overall theory that increasing load bearing area (improving coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony surface may not behave in this manner. It is possible that joint stress may increase when the acetabulum is reoriented into a position that increases load bearing area if post-operative joint congruency is worse than pre-operative.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 18-40 years old
Key inclusion criteria (3 listed)
- Patients aged 18-40 years
- Patients who have undergone periacetabular osteotomy by Dr. Peters for treatment of hip dysplasia.
- Patients who have previously participated in IRB #10983 "Comparative Stress Analysis of Hip Dysplasia".
Key exclusion criteria (5 listed)
- Persons with a history of allergies to lidocaine or seafood.
- Children under the age of 18.
- Persons incarcerated, on trial, or parole.
- Women who are pregnant.
- Subjects who do not have high quality pre-operative images available or have not been surgically treated by periacetabular osteotomy.
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
To predict cartilage contact pressures in the hip joint during simulated daily activities before and after periacetabular osteotomy (PAO) for correction of traditional dysplasia/retroversion.
Time frame: 1 year post surgery
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 4 Nov 2019.
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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.
Andrew Anderson principal investigator
Orthopedic Surgery Operations
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Dysplasia, run by University of Utah.
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 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
To predict cartilage contact pressures in the hip joint during simulated daily activities before and after periacetabular osteotomy (PAO) for correction of traditional dysplasia/retroversion. (time frame: 1 year post surgery). 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 4 Nov 2019.