Functional Capacity After Computer Assisted Periacetabular Osteotomy in Patients With Hip Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02015247
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Pathogenesis of hip dysplasia Hip dysplasia is multifactorial in origin influenced by genetic and intrauterine factors, such as mechanical (rump presentation and oligohydramnios) and hormonal factors1. To ease the passage through the birth canal, the hip joint is quite mobile perinatally. Postnatally, the laxity of the ligaments will subside and the femoral head will normally position itself deeply in the acetabulum2. The theory is that if the femoral head does not migrate sufficiently into the acetabulum, dysplasia may develop because the matrice to stimulate acetabular growth is not correctly positioned. Normally, at birth the femoral head sits deep in the acetabulum held by surface tension of the synovial liquid. The growth and the hemispherical morphology of acetabulum are dependent on the presence of a normally growing and correctly placed spherical femoral head that works as a convex matrice. If for some reason the normal development is disturbed pre- or postnatally, pathologic relations may develop between the femoral head and the acetabulum3, leading to hip dysplasia.

Purpose of this research project is to investigate if the correction of the acetabulum is accurately performed when the surgeon use navigation equipment during PAO.

Condition or disease Intervention/treatment Phase
Hip Dysplasia Procedure: computer-assisted surgery Not Applicable

Detailed Description:

Morphological changes in hip dysplasia The dysplastic hip joint has a complex morphology characterised by a wide shallow acetabular cavity with an excessively oblique articulating roof. The acetabular cover of the femoral head is globally deficient4;5 and the acetabular rim is hypertrophied possibly due to excessive pull from the often hypertrophic labrum. Anteversion is normal5-7, but occasionally the acetabulum is retroverted8;9. The weight-bearing area between the acetabular roof and head is reduced and the articular cartilage is significantly thicker than normal10. Hip dysplasia is often associated with increased anteversion of the femoral neck5;11 and with valgus neck-shaft angle that results in a reduced abductor lever arm12. However the deformities vary from individual to individual and retroversion of the femoral neck has also been reported in hip dysplasia12. Patients with hip dysplasia are prone to developing osteoarthritis of the hip at a young age 13;14. The reasons for this are not fully understood, but an explanation could be that the reduced contact area between acetabulum and the femoral head as well as a reduced abductor lever arm increase the load per contact-area in the hip joint4. The increased load is a strain on the articular cartilage and believed to result in degeneration of cartilage and the subchondral bone and eventually osteoarthritis14-17. The purpose of periacetabular osteotomy (PAO) is to increase acetabular cover of the femoral head and thereby distribute pressures better over the available cartilage surface.

PAO followed by rehabilitation At PAO, the pubic bone is osteotomized and under fluoroscopic control, the ischial osteotomies and the posterior iliac osteotomy are performed. The acetabular fragment is repositioned to optimise coverage of the femoral head. The repositioning is very challenging and clearly the most demanding aspect of the procedure18. Four weeks after discharge, the rehabilitation is initiated and carried out by two physiotherapists specialised in orthopaedics. The patients come to the hospital for physiotherapy twice a week and each exercise session is 1 hour with a 30-minute aerobic and strength program followed by a 30-minute program of mobility and gait training. Physiotherapy is ended 2-3 months after PAO when the physiotherapists assess that the patient has achieved predetermined functional goals e.g. walking at speed without crutches and ability to run. As a result of the patients' young age, they have had a high physical function and it is the aim, that they will regain this level of function after PAO. It is not yet examined whether PAO patients after surgery attain the functional capacity comparable to the age- and gender-matched population.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Capacity After Computer Assisted Periacetabular Osteotomy in Patients With Hip Dysplasia
Study Start Date : December 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
computer-assisted surgery
use of computer-assisted navigation during periacetabular osteotomy
Procedure: computer-assisted surgery
use of computer-assisted navigation during periacetabular osteotomy

Primary Outcome Measures :
  1. correction of acetabular fragment in 3D [ Time Frame: 4 months postop ]
    position of acetabular fragment measured in three dimensions

Secondary Outcome Measures :
  1. functional capacity [ Time Frame: 1 year postop ]
    measured in functional tests with inertia-based measurement analysis

Other Outcome Measures:
  1. activity [ Time Frame: 4 and 12 months postop ]
    activity measured with 3-axial accelerometer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Radiological diagnosed dysplasia (i.e. centre-edge angle < 25 degrees)
  • osteoarthritis degree ≤ 1 according to the criteria of Tonnis
  • pain from hip
  • minimum 110 degrees flexion in the hip and good rotation
  • closed growth zones in the pelvis

Exclusion Criteria:

  • neuromuscular diseases
  • previously major hip surgery
  • pain in the leg (>3 on VAS) other than from the hip
  • persons with cognitive problems
  • persons unable to speak or understand Danish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02015247

Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Study Director: Kjeld Søballe, DMSc University of Aarhus
Principal Investigator: Inger Mechlenburg, PhD University of Aarhus
Principal Investigator: Inger Mechlenburg, PhD Aarhus University Hospital

Responsible Party: University of Aarhus Identifier: NCT02015247     History of Changes
Other Study ID Numbers: Functional capacity PAO
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: August 2013

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