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

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

This study has been completed.

Study NCT00119977. Last updated on January 31, 2008. Information provided by University of Aarhus

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Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Osteoarthritis

Intervention ^†

Procedure: 1 Periacetabular osteotomy

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2003

Completion Date

December 2007

Eligibility Criteria ^†

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 ^††

Location Countries ^†

Denmark

Administrative Information Fields

NCT ID ^†

NCT00119977

Organization ID

20050605

Secondary IDs ^††

Study Sponsor ^†

University of Aarhus

Collaborators ^††

Investigators ^†

Principal Investigator:

Kjeld Søballe, MD Professor

Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark

Information Provided By

University of Aarhus

Verification Date

January 2008

First Received Date ^†

July 5, 2005

Last Updated Date

January 31, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.