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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119977
• Other study ID #: 20050605
• Status: Completed
• Phase: N/A
• First received: July 5, 2005
• Last updated: January 31, 2008
• Start date: October 2003
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• 1 Periacetabular osteotomy
pelvic osteotomy to increase acetabular coverage

Locations

Country	Name	City	State
Denmark	Orthopaedic Center, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	migration of acetabulum		six months	No
Secondary	BMD in acetabulum		within two and a half year	No
Secondary	status of labrum		three years after pelvic osteotomy	No
Secondary	changes in cartilage thickness		two and half a year	No