Developmental Dysplasia of the HipNCT01345838
Acetabular Labral Tear in Dysplastic Hips
An observational study of Developmental Dysplasia of the Hip and Labrum, run by University of Aarhus at 1 site in Denmark.
Trial summary
A prospective case-control study of the clinical and radiographic outcome of periacetabular osteotomy in patients with and without preoperative acetabular labral tears. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Developmental Dysplasia of the Hip, Labrum
- What is being tested?
- labrum
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Sep 2013
- 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: Consecutive patients with developmental dysplasia of hip and who is scheduled for PAO
Who may be able to join
- Developmental dysplasia of the hip
Who cannot join
- contraindication for magnetic resonance arthrography
- severe deformities of the femural head
Trial locations and contacts
1 site in 1 country.
About this study
A prospective case-control study of the clinical and radiographic outcome of periacetabular osteotomy in patients with and without preoperative acetabular labral tears.
- Conditions
- Developmental Dysplasia of the Hip, Labrum
- Being tested
- labrum
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labrumProcedure or surgery
Two years follow-up after PAO, to find any differences among patients with and without known acetabular labral tears
| Study group | Role | What they receive |
|---|---|---|
| Dysplasia | Patients with developmental dysplasia of the hip undergoing PAO Receives: Procedure: labrum |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjeld Soballe, Prof. D.Msc, Study chair, Orthopedic Research Unit, Aarhus University HospitalCharlotte Hartig-Andreasen, MD, Principal investigator, Orthopedic Research Unit, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345838
- Sponsor's protocol ID
- PAO and labrum
- Status last verified
- Jan 2023
- First submitted
- 29 Apr 2011
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetabular Labral Tear in Dysplastic Hips
- ClinicalTrials.gov ID
- NCT01345838
- Acronym / sponsor ID
- PAO and labrum
- Conditions
- Developmental Dysplasia of the Hip, Labrum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 May 2011 (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 prospective case-control study of the clinical and radiographic outcome of periacetabular osteotomy in patients with and without preoperative acetabular labral tears.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysplasia | – | Procedure: labrumPatients with developmental dysplasia of the hip undergoing PAO |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with developmental dysplasia of hip and who is scheduled for PAO
Key inclusion criteria (1 listed)
- Developmental dysplasia of the hip
Key exclusion criteria (2 listed)
- contraindication for magnetic resonance arthrography
- severe deformities of the femural head
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 |
|---|---|---|
| labrumTwo years follow-up after PAO, to find any differences among patients with and without known acetabular labral tears | Procedure or surgery | Dysplasia |
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 9 Jan 2023.
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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.
Kjeld Soballe, Prof. D.Msc study chair
Orthopedic Research Unit, Aarhus University Hospital
Charlotte Hartig-Andreasen, MD principal investigator
Orthopedic Research Unit, Aarhus University 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 Developmental Dysplasia of the Hip and Labrum, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 2 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 9 Jan 2023. 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 Denmark. 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 9 Jan 2023.