Developmental Dysplasia of the HipNCT02945995
Outcome After Arthroscopic Surgery in Patients Treated With PAO
An observational study of Developmental Dysplasia of the Hip, run by Aarhus University Hospital.
Trial summary
The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- hip arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- 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 undergoing hip arthrocopy previous treated with periacetabular osteotomy
Who may be able to join
- previous PAO and hip arthroscopy
- developmental dysplasia of the hip
Who cannot join
- calve legg perthes disease
- femoral osteotomy
About this study
Official title: Outcome After Arthroscopic Labrum Surgery in Patients Treated With Periacetabular Osteotomy
The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy
Read the detailed description
It is well known the patients with developmental dysplasia of the hip beyond the bony malformation has intraarticular damage to labrum and chondral structures.
In DK, if the patients has persistent pain in the hip joint after PAO, they have been offered a hip arthroscopy, however we do not if their hip functions and pain improved by the surgery
The investigator aimed to make a short to middle-term followup study to see if the patients had benefits of the surgery.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- hip arthroscopy
- 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.
hip arthroscopyProcedure or surgery
Follow up after hip arthroscopy in pt with previous PAO. Follow up by questionnaires send til the cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with the need of a total hip arthroplasty after PAO and hip arthroscopy
Questionnaire
Measured: 48 months after hip arthroscopy
Secondary outcomes (3)
Evaluation of the patients pain in rest and during activity on a NRS Scale
Questionnaire
Measured: 48 months after hip arthroscopy
Evaluation of hip function and pain using MHHS (modified harris hip score)
Questionnaire
Measured: 48 months after hip arthroscopy
Evaluation of hip function and pain using HOS (Hip outcome score)
Questionnaire
Measured: 48 months after hip arthroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2016
- Study completionDec 2016
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.
- More trials run by Aarhus University HospitalThe 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
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
- Investigators
- Martin Lind, MD,PhD,DmSc, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945995
- Sponsor's protocol ID
- CHA-PostPAO
- Status last verified
- Oct 2016
- First submitted
- 18 Mar 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Arthroscopic Labrum Surgery in Patients Treated With Periacetabular Osteotomy
- ClinicalTrials.gov ID
- NCT02945995
- Acronym / sponsor ID
- CHA-PostPAO
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Oct 2016 (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 purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy
Detailed description
It is well known the patients with developmental dysplasia of the hip beyond the bony malformation has intraarticular damage to labrum and chondral structures.
In DK, if the patients has persistent pain in the hip joint after PAO, they have been offered a hip arthroscopy, however we do not if their hip functions and pain improved by the surgery
The investigator aimed to make a short to middle-term followup study to see if the patients had benefits of the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing hip arthrocopy previous treated with periacetabular osteotomy
Key inclusion criteria (2 listed)
- previous PAO and hip arthroscopy
- developmental dysplasia of the hip
Key exclusion criteria (2 listed)
- calve legg perthes disease
- femoral osteotomy
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 |
|---|---|---|
| hip arthroscopyFollow up after hip arthroscopy in pt with previous PAO. Follow up by questionnaires send til the cohort | Procedure or surgery | – |
Primary outcome
Number of patient with the need of a total hip arthroplasty after PAO and hip arthroscopy
Time frame: 48 months after hip arthroscopy
Questionnaire
3 secondary outcomes
Evaluation of the patients pain in rest and during activity on a NRS Scale
Time frame: 48 months after hip arthroscopy
Evaluation of hip function and pain using MHHS (modified harris hip score)
Time frame: 48 months after hip arthroscopy
Evaluation of hip function and pain using HOS (Hip outcome score)
Time frame: 48 months after hip arthroscopy
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 23 Feb 2017.
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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.
Martin Lind, MD,PhD,DmSc study director
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dysplasia of the Hip, run by Aarhus University Hospital.
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 2 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 23 Feb 2017. 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?
Number of patient with the need of a total hip arthroplasty after PAO and hip arthroscopy (time frame: 48 months after hip arthroscopy). 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 23 Feb 2017.