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Movement Pattern in Patients With Hip Dysplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier:
NCT01344421
First received: April 27, 2011
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Hip Dysplasia
Procedure: Minimally invasive approach for Periacetabular osteotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Movement Pattern in Patients With Hip Dysplasia Operated With Minimally Invasive Approach in Peri-acetabular Osteotomy (PAO)

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Hip flexion's muscle moment in stance evaluated in gait, run and jump test [ Time Frame: Preoperative (baseline), 6 and 12 month postoperative ] [ Designated as safety issue: No ]
    Examined using 3D Movement Capture System


Secondary Outcome Measures:
  • Hip extension angle evaluated in gait, run and jump test [ Time Frame: Preoperative (baseline), 6 and 12 month postoperative ] [ Designated as safety issue: No ]
    Examined using 3D Movement Capture Systen

  • On-set of the hip muscles evaluated in gait, run and jump test [ Time Frame: Preoperative (baseline), 6 and 12 month postoperative ] [ Designated as safety issue: No ]
    Examined using skin electromyography (EMG)

  • Function, sports and recreational activities [ Time Frame: Preoperative (baseline), 6 and 12 month postoperative ] [ Designated as safety issue: No ]
    Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS)

  • Quality of life [ Time Frame: preoperative (baseline), 6 and 12 month postoperative ] [ Designated as safety issue: No ]
    Evaluated with Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and The Copenhagen Hip and Groin Outcome Score (HAGOS)


Enrollment: 55
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hip dysplasia
Patients with hip dysplasia
Procedure: Minimally invasive approach for Periacetabular osteotomy
A peri-acetabular osteotomy is a surgery performed to correct the dysplastic acetabulum and reduce joint contact pressures and early osteoarthritis.
Other Name: PAO (periacetabular osteotomy)
Healthy people
Enrolled from the patients acquaintance circle

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with hip dysplasia and waiting for surgery.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344421

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
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
  More Information

No publications provided

Responsible Party: University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier: NCT01344421     History of Changes
Other Study ID Numbers: M-20100206
Study First Received: April 27, 2011
Last Updated: April 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Movement capture system
Movement analysis
Hip dysplasia
Hip pain
Quality of life
Physical function

Additional relevant MeSH terms:
Hip Dislocation
Hip Dislocation, Congenital
Congenital Abnormalities
Dislocations
Hip Injuries
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014