- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01344421
Movement Pattern in Patients With Hip Dysplasia
Movement Pattern in Patients With Hip Dysplasia Operated With Minimally Invasive Approach in Peri-acetabular Osteotomy (PAO)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aarhus, Denmark, 8000
- Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with hip dysplasia
- Patients in the age of 18-60 years
- Patients, who can speak, understand and read Danish
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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hip dysplasia
Patients with hip dysplasia
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A peri-acetabular osteotomy is a surgery performed to correct the dysplastic acetabulum and reduce joint contact pressures and early osteoarthritis.
Other Names:
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Healthy people
Enrolled from the patients acquaintance circle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hip flexion's muscle moment in stance evaluated in gait, run and jump test
Time Frame: Preoperative (baseline), 6 and 12 month postoperative
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Examined using 3D Movement Capture System
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Preoperative (baseline), 6 and 12 month postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hip extension angle evaluated in gait, run and jump test
Time Frame: Preoperative (baseline), 6 and 12 month postoperative
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Examined using 3D Movement Capture Systen
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Preoperative (baseline), 6 and 12 month postoperative
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On-set of the hip muscles evaluated in gait, run and jump test
Time Frame: Preoperative (baseline), 6 and 12 month postoperative
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Examined using skin electromyography (EMG)
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Preoperative (baseline), 6 and 12 month postoperative
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Function, sports and recreational activities
Time Frame: Preoperative (baseline), 6 and 12 month postoperative
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Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS)
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Preoperative (baseline), 6 and 12 month postoperative
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Quality of life
Time Frame: preoperative (baseline), 6 and 12 month postoperative
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Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS)
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preoperative (baseline), 6 and 12 month postoperative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie S Jacobsen, MSc, Aarhus University Hospital
- Principal Investigator: Inger Mechlenburg, MSc, PhD, Aarhus University Hospital
- Study Chair: Kjeld Søballe, Prof. Dr.med, Aarhus University Hospital
- Study Chair: Henrik Sørensen, PhD, University of Aarhus
- Study Chair: Dennis Nielsen, MSc, University of Aarhus
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20100206
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