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

NCT ID: NCT00119977

Last Updated: 2008-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2007-12-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

1 Periacetabular osteotomy

Intervention Type: PROCEDURE

pelvic osteotomy to increase acetabular coverage

Interventions

1 Periacetabular osteotomy

pelvic osteotomy to increase acetabular coverage

Intervention Type: PROCEDURE

Other Intervention Names

periacetabular osteotomy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Aarhus University Hospital

Principal Investigators

Kjeld Søballe, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark

Locations

Orthopaedic Center, Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

20050605

Identifier Type: -

Identifier Source: org_study_id