Hip DysplasiaNCT01344421
Movement Pattern in Patients With Hip Dysplasia
An observational study of Hip Dysplasia, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- Minimally invasive approach for Periacetabular osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Mar 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients diagnosed with hip dysplasia and waiting for surgery.
Who may be able to join
- Patients diagnosed with hip dysplasia
- Patients in the age of 18-60 years
- Patients, who can speak, understand and read Danish
Who cannot join
- Persons with hip dysplasia secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.
- Persons who have had alloplastic surgery in the hip, knee or ankle.
- Persons with diseases that affect the gait pattern.
- Persons with serious hip, knee, ankle or back pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Movement Pattern in Patients With Hip Dysplasia Operated With Minimally Invasive Approach in Peri-acetabular Osteotomy (PAO)
The purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.
Read the detailed description
Congenital hip dysplasia is a disease characterised by pathological changes in the hip joint. Hip dysplasia is a normal disease with a prevalence of 4.3% in men and 3.6 in woman. Untreated hip dysplasia is a known cause of developing osteoarthritis early in life and symptoms as pain, hip instability together with a changed gait pattern are normal. Symptomatic hip dysplasia is seen in patients between 15 and 55 years and can be unilateral as well as bilateral. Causes of hip dysplasia are described as genetic, mechanic or hormonal.
Today patients with hip dysplasia are offered a hip conserving surgery before the osteoarthritis has developed. In 2003 a minimally invasive approach for periacetabular osteotomy (PAO) was introduced at Aarhus University Hospital. An advantage of minimally invasive approach compared to the classical Bernese periacetabular osteotomy is minimal impact of the soft tissues in the hip region.
Hip pain and activity limitations highly affect quality of life and physical function. The gait distance is reduced and patients have to compensate to relieve the pressure on the hip joint. Knowledge about the dynamics of the gait and running pattern in patients with dysplasia is important to understand the consequences of the dysplastic hip joint. Furthermore knowledge about gait compensations is relevant for the clinicians in the management and treatment of patients with hip dysplasia.
Today, gait and running compensation is unknown after minimally invasive approach The purpose of this study is, therefore, to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Peri-acetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.
- Conditions
- Hip Dysplasia
- Being tested
- Minimally invasive approach for Periacetabular osteotomy
- Keywords
- Movement capture system, Movement analysis, Hip dysplasia, Hip pain, Quality of life, Physical function
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive approach for Periacetabular osteotomyProcedure or surgery
Also called PAO (periacetabular osteotomy)
A peri-acetabular osteotomy is a surgery performed to correct the dysplastic acetabulum and reduce joint contact pressures and early osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| hip dysplasia | Patients with hip dysplasia Receives: Procedure: Minimally invasive approach for Periacetabular osteotomy | |
| Healthy people | Enrolled from the patients acquaintance circle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip flexion's muscle moment in stance evaluated in gait, run and jump test
Examined using 3D Movement Capture System
Measured: Preoperative (baseline), 6 and 12 month postoperative
Secondary outcomes (4)
Hip extension angle evaluated in gait, run and jump test
Examined using 3D Movement Capture Systen
Measured: Preoperative (baseline), 6 and 12 month postoperative
On-set of the hip muscles evaluated in gait, run and jump test
Examined using skin electromyography (EMG)
Measured: Preoperative (baseline), 6 and 12 month postoperative
Function, sports and recreational activities
Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS)
Measured: Preoperative (baseline), 6 and 12 month postoperative
Quality of life
Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS)
Measured: preoperative (baseline), 6 and 12 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie S Jacobsen, MSc, Principal investigator, Aarhus University HospitalInger Mechlenburg, MSc, PhD, Principal investigator, Aarhus University HospitalKjeld Søballe, Prof. Dr.med, Study chair, Aarhus University HospitalHenrik Sørensen, PhD, Study chair, University of AarhusDennis Nielsen, MSc, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344421
- Sponsor's protocol ID
- M-20100206
- Status last verified
- Apr 2013
- First submitted
- 27 Apr 2011
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sorensen H, Skalshoi O, Nielsen DB, Jacobsen JS, Soballe K, Mechlenburg I. Hip muscle and joint contact forces before, 6 and 12 months after minimally invasive periacetabular osteotomy. Hip Int. 2021 Sep;31(5):676-682. doi: 10.1177/1120700020925411. Epub 2020 May 4.
PubMed 32366122
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Pattern in Patients With Hip Dysplasia Operated With Minimally Invasive Approach in Peri-acetabular Osteotomy (PAO)
- ClinicalTrials.gov ID
- NCT01344421
- Acronym / sponsor ID
- M-20100206
- Conditions
- Hip Dysplasia
- Keywords
- Movement capture system, Movement analysis, Hip dysplasia, Hip pain, Quality of life, Physical function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Apr 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.
The purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.
Detailed description
Congenital hip dysplasia is a disease characterised by pathological changes in the hip joint. Hip dysplasia is a normal disease with a prevalence of 4.3% in men and 3.6 in woman. Untreated hip dysplasia is a known cause of developing osteoarthritis early in life and symptoms as pain, hip instability together with a changed gait pattern are normal. Symptomatic hip dysplasia is seen in patients between 15 and 55 years and can be unilateral as well as bilateral. Causes of hip dysplasia are described as genetic, mechanic or hormonal.
Today patients with hip dysplasia are offered a hip conserving surgery before the osteoarthritis has developed. In 2003 a minimally invasive approach for periacetabular osteotomy (PAO) was introduced at Aarhus University Hospital. An advantage of minimally invasive approach compared to the classical Bernese periacetabular osteotomy is minimal impact of the soft tissues in the hip region.
Hip pain and activity limitations highly affect quality of life and physical function. The gait distance is reduced and patients have to compensate to relieve the pressure on the hip joint. Knowledge about the dynamics of the gait and running pattern in patients with dysplasia is important to understand the consequences of the dysplastic hip joint. Furthermore knowledge about gait compensations is relevant for the clinicians in the management and treatment of patients with hip dysplasia.
Today, gait and running compensation is unknown after minimally invasive approach The purpose of this study is, therefore, to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Peri-acetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hip dysplasia | – | Procedure: Minimally invasive approach for Periacetabular osteotomyPatients with hip dysplasia |
| Healthy people | – | –Enrolled from the patients acquaintance circle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with hip dysplasia and waiting for surgery.
Key inclusion criteria (3 listed)
- Patients diagnosed with hip dysplasia
- Patients in the age of 18-60 years
- Patients, who can speak, understand and read Danish
Key exclusion criteria (4 listed)
- Persons with hip dysplasia secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.
- Persons who have had alloplastic surgery in the hip, knee or ankle.
- Persons with diseases that affect the gait pattern.
- Persons with serious hip, knee, ankle or back pain.
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 |
|---|---|---|
| Minimally invasive approach for Periacetabular osteotomyAlso: PAO (periacetabular osteotomy)A peri-acetabular osteotomy is a surgery performed to correct the dysplastic acetabulum and reduce joint contact pressures and early osteoarthritis. | Procedure or surgery | hip dysplasia |
Primary outcome
Hip flexion's muscle moment in stance evaluated in gait, run and jump test
Time frame: Preoperative (baseline), 6 and 12 month postoperative
Examined using 3D Movement Capture System
4 secondary outcomes
Hip extension angle evaluated in gait, run and jump test
Time frame: Preoperative (baseline), 6 and 12 month postoperative
On-set of the hip muscles evaluated in gait, run and jump test
Time frame: Preoperative (baseline), 6 and 12 month postoperative
Function, sports and recreational activities
Time frame: Preoperative (baseline), 6 and 12 month postoperative
Quality of life
Time frame: preoperative (baseline), 6 and 12 month postoperative
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 5 Apr 2013.
- Derived from this study: PubMed 32366122Sorensen H, Skalshoi O, Nielsen DB, Jacobsen JS, Soballe K, Mechlenburg I. Hip muscle and joint contact forces before, 6 and 12 months after minimally invasive periacetabular osteotomy. Hip Int. 2021 Sep;31(5):676-682. doi: 10.1177/1120700020925411. Epub 2020 May 4.
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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.
Julie S Jacobsen, MSc principal investigator
Aarhus University Hospital
Inger Mechlenburg, MSc, PhD principal investigator
Aarhus University Hospital
Kjeld Søballe, Prof. Dr.med study chair
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, run by Aarhus University Hospital 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 3 inclusion and 4 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 5 Apr 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?
Hip flexion's muscle moment in stance evaluated in gait, run and jump test (time frame: Preoperative (baseline), 6 and 12 month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344421, which also lists 1 linked publication.
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 5 Apr 2013.