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

Tracking Information

First Received Date ^ICMJE

July 5, 2005

Last Updated Date

January 31, 2008

Start Date ^ICMJE

October 2003

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

migration of acetabulum [ Time Frame: six months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

migration of acetabulum
changes in cartilage thickness

Change History

Complete list of historical versions of study NCT00119977 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

BMD in acetabulum [ Time Frame: within two and a half year ] [ Designated as safety issue: No ]
status of labrum [ Time Frame: three years after pelvic osteotomy ] [ Designated as safety issue: No ]
changes in cartilage thickness [ Time Frame: two and half a year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

BMD in acetabulum

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Procedure: 1 Periacetabular osteotomy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00119977

Responsible Party

Inger Mechlenburg, post doc., Aarhus University Hospital

Study ID Numbers ^ICMJE

20050605

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kjeld Søballe, MD Professor

Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark

Information Provided By

University of Aarhus

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP