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Completed

NCT Number: NCT00119977

Periacetabular Osteotomy.A Prospective Study With Reference to Cartilage, Migration and Bone Density

The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Center, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

The cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint contact pressures secondary to decreased acetabular coverage of the femoral head and/or incongruity of the articular surfaces. The investigators' hypothesis is that when periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has happened at the time periacetabular osteotomy is performed. Hence, the purposes of this study are:

  • to develop an unbiased and precise method for measurement of the thickness of the articular cartilage in the hip joint because such a method can be used to evaluate the effect of periacetabular osteotomy and also to give a more precise indication/contraindication for surgery;
  • to evaluate the migration of the acetabulum postoperatively and 6 months after surgery by use of RSA to examine the stability of the osteotomy; and
  • to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to find out whether the change in load distribution will affect bone density of the acetabulum over time in a way that in the area where more load is applied, bone density will increase, and in areas with less load, bone density will decrease;
  • to examine the labrum in the hip joint.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with radiologically diagnosed hip dysplasia (CE-angle < 25°)
  • Patients with osteoarthritis graded 0, 1 or 2 defined according to Tönnis' classification
  • Patients with pain from hip
  • Age > 18 years
  • Minimum 110° flexion in hip joint and closed growth zones in the pelvic region
  • Informed consent

Exclusion criteria

  • Patients with neurological diseases
  • Patients with calvé-Legg-Perthes syndrome
  • Patients where a femoral intertrochanteric osteotomy is necessary
  • Patients with medical sequelae after earlier hip surgery
  • Females who are pregnant
  • Patients with metal implants

Treatment and study plan

1 Periacetabular osteotomy

Procedure

pelvic osteotomy to increase acetabular coverage

Other names: periacetabular osteotomy

Primary outcomes

  1. migration of acetabulum

    Time frame: six months

Secondary outcomes

  1. BMD in acetabulum

    Time frame: within two and a half year

  2. status of labrum

    Time frame: three years after pelvic osteotomy

  3. changes in cartilage thickness

    Time frame: two and half a year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Periacetabular Osteotomy. A Prospective Study With Reference to Cartilage, Migration and Bone Density

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jul 14, 2005
Registry last updated
Feb 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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