OsteoarthritisNCT00119444
Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography
A study testing Periacetabular osteotomy in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Periacetabular osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Aug 2009
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with radiologically diagnosed hip dysplasia (CE-angle < 25°).
- Patients with osteoarthritis graded 0, 1 or 2 defined according to Tönnis' classification. Patients with pain from hip
- Age > 18 years.
- Minimum 110° flexion in hip joint and closed growth zones in the pelvic.
- Informed consent.
Who cannot join
- Patients with neurological diseases
- Patients with calvé-Legg-Perthes syndrome.
- Patients where an femoral intertrochanteric osteotomy is necessary.
- Patients with medical sequelae after earlier hip surgery.
- Females who are pregnant.
- Patients with metal implants.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET).
Read the detailed description
As a consequence of periacetabular osteotomy the blood flow in acetabulum is decreased. After periacetabular osteotomy has been performed there is fine contact between the osteotomised acetabulum and the rest of the pelvis and the potential for healing is good. However, it has not been investigated how much the blood flow in acetabulum is changed after surgery. The blood flow is considered to be vital for how the pelvis heals after surgery. Most likely, the blood flow is important in relation to which degree osteoarthritis can be prevented after periacetabular osteotomy.
It is possible to estimate the blood flow by Positron Emission Tomography of the dysplastic hip joint pre- and postoperatively. In this study the blood flow and fluoride uptake is quantified by Positron emission tomography based on measurements of O-15 water and F-18 fluoride.
- Conditions
- Osteoarthritis
- Being tested
- Periacetabular osteotomy
- Keywords
- PET, Periacetabular osteotomy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periacetabular osteotomyProcedure or surgery
Also called PAO
osteotomy of the pelvis to increase acetabular coverage
| Study group | Role | What they receive |
|---|---|---|
| periacetabular osteotomy | Other | Not described Receives: Procedure: Periacetabular osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in blood flow
Measured: within the first three weeks after operation
Secondary outcomes (1)
fluoride uptake
Measured: within the first three weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2005 (estimated)
- Study startJan 2004
- Primary completionJan 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjeld Søballe, MD, Prof., Principal investigator, Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119444
- Sponsor's protocol ID
- 20050606
- Status last verified
- Sep 2009
- First submitted
- 5 Jul 2005
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT00119444
- Acronym / sponsor ID
- 20050606
- Conditions
- Osteoarthritis
- Keywords
- PET, Periacetabular osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Jul 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.
The purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET).
Detailed description
As a consequence of periacetabular osteotomy the blood flow in acetabulum is decreased. After periacetabular osteotomy has been performed there is fine contact between the osteotomised acetabulum and the rest of the pelvis and the potential for healing is good. However, it has not been investigated how much the blood flow in acetabulum is changed after surgery. The blood flow is considered to be vital for how the pelvis heals after surgery. Most likely, the blood flow is important in relation to which degree osteoarthritis can be prevented after periacetabular osteotomy.
It is possible to estimate the blood flow by Positron Emission Tomography of the dysplastic hip joint pre- and postoperatively. In this study the blood flow and fluoride uptake is quantified by Positron emission tomography based on measurements of O-15 water and F-18 fluoride.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periacetabular osteotomy | Other | Procedure: Periacetabular osteotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with radiologically diagnosed hip dysplasia (CE-angle < 25°).
- Patients with osteoarthritis graded 0, 1 or 2 defined according to Tönnis' classification. Patients with pain from hip
- Age > 18 years.
- Minimum 110° flexion in hip joint and closed growth zones in the pelvic.
- Informed consent.
Key exclusion criteria (6 listed)
- Patients with neurological diseases
- Patients with calvé-Legg-Perthes syndrome.
- Patients where an femoral intertrochanteric osteotomy is necessary.
- Patients with medical sequelae after earlier hip surgery.
- Females who are pregnant.
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 |
|---|---|---|
| Periacetabular osteotomyAlso: PAOosteotomy of the pelvis to increase acetabular coverage | Procedure or surgery | periacetabular osteotomy |
Primary outcome
changes in blood flow
Time frame: within the first three weeks after operation
1 secondary outcome
fluoride uptake
Time frame: within the first three weeks after operation
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 20 Nov 2015.
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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 Søballe, MD, Prof. principal investigator
Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periacetabular osteotomy in people with Osteoarthritis, 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 5 inclusion and 6 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 20 Nov 2015. 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?
changes in blood flow (time frame: within the first three weeks after operation). 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 20 Nov 2015.