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

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: NCT00119977
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : February 12, 2008
Information provided by:
University of Aarhus

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

Condition or disease Intervention/treatment
Osteoarthritis Procedure: 1 Periacetabular osteotomy

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Periacetabular Osteotomy. A Prospective Study With Reference to Cartilage, Migration and Bone Density
Study Start Date : October 2003
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Procedure: 1 Periacetabular osteotomy
pelvic osteotomy to increase acetabular coverage
Other Name: periacetabular osteotomy

Primary Outcome Measures :
  1. migration of acetabulum [ Time Frame: six months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00119977

Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Kjeld Søballe, MD Professor Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark

Responsible Party: Inger Mechlenburg, post doc., Aarhus University Hospital Identifier: NCT00119977     History of Changes
Other Study ID Numbers: 20050605
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: February 12, 2008
Last Verified: January 2008

Keywords provided by University of Aarhus:
cartilage thickness
ultra sound
periacetabular osteotomy

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases