OsteoarthritisNCT00119977
Periacetabular Osteotomy.A Prospective Study With Reference to Cartilage, Migration and Bone Density
A study testing 1 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 evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- 1 Periacetabular osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2003to Dec 2007
- 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 region
- Informed consent
Who cannot join
- Patients with neurological diseases
- Patients with calvé-Legg-Perthes syndrome
- Patients where a 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
Official title: Periacetabular Osteotomy. A Prospective Study With Reference to Cartilage, Migration and Bone Density
The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia.
Read the detailed description
The cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint contact pressures secondary to decreased acetabular coverage of the femoral head and/or incongruity of the articular surfaces. The investigators' hypothesis is that when periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has happened at the time periacetabular osteotomy is performed. Hence, the purposes of this study are:
- to develop an unbiased and precise method for measurement of the thickness of the articular cartilage in the hip joint because such a method can be used to evaluate the effect of periacetabular osteotomy and also to give a more precise indication/contraindication for surgery;
- to evaluate the migration of the acetabulum postoperatively and 6 months after surgery by use of RSA to examine the stability of the osteotomy; and
- to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to find out whether the change in load distribution will affect bone density of the acetabulum over time in a way that in the area where more load is applied, bone density will increase, and in areas with less load, bone density will decrease;
- to examine the labrum in the hip joint.
- Conditions
- Osteoarthritis
- Being tested
- 1 Periacetabular osteotomy
- Keywords
- cartilage thickness, RSA, DEXA, ultra sound, MRI, osteoarthritis, 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.
1 Periacetabular osteotomyProcedure or surgery
Also called periacetabular osteotomy
pelvic osteotomy to increase acetabular coverage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: 1 Periacetabular osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
migration of acetabulum
Measured: six months
Secondary outcomes (3)
BMD in acetabulum
Measured: within two and a half year
status of labrum
Measured: three years after pelvic osteotomy
changes in cartilage thickness
Measured: two and half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startOct 2003
- Primary completionDec 2007
- Study completionDec 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Kjeld Søballe, MD Professor, Principal investigator, Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119977
- Sponsor's protocol ID
- 20050605
- Status last verified
- Jan 2008
- First submitted
- 5 Jul 2005
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periacetabular Osteotomy. A Prospective Study With Reference to Cartilage, Migration and Bone Density
- ClinicalTrials.gov ID
- NCT00119977
- Acronym / sponsor ID
- 20050605
- Conditions
- Osteoarthritis
- Keywords
- cartilage thickness, RSA, DEXA, ultra sound, MRI, osteoarthritis, periacetabular osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 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 evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia.
Detailed description
The cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint contact pressures secondary to decreased acetabular coverage of the femoral head and/or incongruity of the articular surfaces. The investigators' hypothesis is that when periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has happened at the time periacetabular osteotomy is performed. Hence, the purposes of this study are:
- to develop an unbiased and precise method for measurement of the thickness of the articular cartilage in the hip joint because such a method can be used to evaluate the effect of periacetabular osteotomy and also to give a more precise indication/contraindication for surgery;
- to evaluate the migration of the acetabulum postoperatively and 6 months after surgery by use of RSA to examine the stability of the osteotomy; and
- to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to find out whether the change in load distribution will affect bone density of the acetabulum over time in a way that in the area where more load is applied, bone density will increase, and in areas with less load, bone density will decrease;
- to examine the labrum in the hip joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: 1 Periacetabular osteotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 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 region
Key exclusion criteria (6 listed)
- Patients with neurological diseases
- Patients with calvé-Legg-Perthes syndrome
- Patients where a 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 |
|---|---|---|
| 1 Periacetabular osteotomyAlso: periacetabular osteotomypelvic osteotomy to increase acetabular coverage | Procedure or surgery | 1 |
Primary outcome
migration of acetabulum
Time frame: six months
3 secondary outcomes
BMD in acetabulum
Time frame: within two and a half year
status of labrum
Time frame: three years after pelvic osteotomy
changes in cartilage thickness
Time frame: two and half a year
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 12 Feb 2008.
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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 Professor 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 1 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 6 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 12 Feb 2008. 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?
migration of acetabulum (time frame: six months). 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 12 Feb 2008.