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

January 31, 2008 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Orthopaedic Center, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Procedure: 1 Periacetabular osteotomy
pelvic osteotomy to increase acetabular coverage
Other Names:
  • periacetabular osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
migration of acetabulum
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
BMD in acetabulum
Time Frame: within two and a half year
within two and a half year
status of labrum
Time Frame: three years after pelvic osteotomy
three years after pelvic osteotomy
changes in cartilage thickness
Time Frame: two and half a year
two and half a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Kjeld Søballe, MD Professor, Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 5, 2005

First Submitted That Met QC Criteria

July 5, 2005

First Posted (Estimate)

July 14, 2005

Study Record Updates

Last Update Posted (Estimate)

February 12, 2008

Last Update Submitted That Met QC Criteria

January 31, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on 1 Periacetabular osteotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe