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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02015247
First received: July 9, 2013
Last updated: August 15, 2014
Last verified: August 2013
  Purpose

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 Intervention
Hip Dysplasia
Procedure: computer-assisted surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Functional Capacity After Computer Assisted Periacetabular Osteotomy in Patients With Hip Dysplasia

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • correction of acetabular fragment in 3D [ Time Frame: 4 months postop ] [ Designated as safety issue: No ]
    position of acetabular fragment measured in three dimensions


Secondary Outcome Measures:
  • functional capacity [ Time Frame: 1 year postop ] [ Designated as safety issue: No ]
    measured in functional tests with inertia-based measurement analysis


Other Outcome Measures:
  • activity [ Time Frame: 4 and 12 months postop ] [ Designated as safety issue: No ]
    activity measured with 3-axial accelerometer


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
computer-assisted surgery
use of computer-assisted navigation during periacetabular osteotomy
Procedure: computer-assisted surgery
use of computer-assisted navigation during periacetabular osteotomy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02015247

Contacts
Contact: Inger Mechlenburg, PhD 51156585 inger.mechlenburg@au.dk
Contact: Kjeld Soballe, D.M.Sc. kjeld@soballe.com

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Inger Mechlenburg, PhD         
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Inger Mechlenburg, PhD       inger.mechlenburg@au.dk   
Principal Investigator: Inger Mechlenburg, PhD         
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Kjeld Søballe, DMSc University of Aarhus
Principal Investigator: Inger Mechlenburg, PhD University of Aarhus
Principal Investigator: Inger Mechlenburg, PhD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02015247     History of Changes
Other Study ID Numbers: Functional capacity PAO
Study First Received: July 9, 2013
Last Updated: August 15, 2014
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on September 15, 2014