Hip DysplasiaNCT01657357
Routine Follow up After Total Hip Arthroplasty Prior Periacetabular Osteotomy
An observational study of Hip Dysplasia and Osteotomy of Pelvis, run by University of Aarhus at 1 site in Denmark.
Trial summary
Follow up study of patients, who despite periacetabular osteotomy, need a total hip arthroplasty, to see outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Dysplasia, Osteotomy of Pelvis, Total Hip Arthroplasty
- What is being tested?
- Routine followup
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Oct 2012
- 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: Patients, who despite a joint preserving procedure(periacetabular osteotomy PAO) ended up with a total hip arthroplasty (THA).
Who may be able to join
- PAO and THA
Who cannot join
- time since THA less than 4 yrs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic department, Aarhus Universityhospital
Aarhus, Aarhus, 8000
About this study
Official title: Routine Follow up After THA in PAO Patient
Follow up study of patients, who despite periacetabular osteotomy, need a total hip arthroplasty, to see outcome.
- Conditions
- Hip Dysplasia, Osteotomy of Pelvis, Total Hip Arthroplasty
- Being tested
- Routine followup
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine followupOther
questionnaires
| Study group | Role | What they receive |
|---|---|---|
| PAO, osteoarhritis, THA | Not described Receives: Other: Routine followup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does previous PAO compromise the function of a secondary THA
To describe the radiographic status (ex. cup positioning, calcifications, signs of loosing etc) of the THA, the physical function of the THA ( Harris Hip Score), and pt reported outcome measurements (SF36 and WOMAC).
Measured: Up to 10 years after THA surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionOct 2012
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 AarhusThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
- NCT01657357
- Sponsor's protocol ID
- THA after PAO
- Status last verified
- Jan 2013
- First submitted
- 13 Mar 2012
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Follow up After THA in PAO Patient
- ClinicalTrials.gov ID
- NCT01657357
- Acronym / sponsor ID
- THA after PAO
- Conditions
- Hip Dysplasia, Osteotomy of Pelvis, Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Aug 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.
Follow up study of patients, who despite periacetabular osteotomy, need a total hip arthroplasty, to see outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAO, osteoarhritis, THA | – | Other: Routine followup |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients, who despite a joint preserving procedure(periacetabular osteotomy PAO) ended up with a total hip arthroplasty (THA).
Key inclusion criteria (1 listed)
- PAO and THA
Key exclusion criteria (1 listed)
- time since THA less than 4 yrs
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 |
|---|---|---|
| Routine followupquestionnaires | Other | PAO, osteoarhritis, THA |
Primary outcome
Does previous PAO compromise the function of a secondary THA
Time frame: Up to 10 years after THA surgery
To describe the radiographic status (ex. cup positioning, calcifications, signs of loosing etc) of the THA, the physical function of the THA ( Harris Hip Score), and pt reported outcome measurements (SF36 and WOMAC).
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 31 Jan 2013.
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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 Hip Dysplasia and Osteotomy of Pelvis, 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 1 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 31 Jan 2013. 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.
What does the primary outcome measure?
Does previous PAO compromise the function of a secondary THA (time frame: Up to 10 years after THA 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 31 Jan 2013.