Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

Osteoarthritis Clinical Trial

Official title:

Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119444
• Other study ID #: 20050606
• Status: Completed
• Phase: N/A
• First received: July 5, 2005
• Last updated: November 19, 2015
• Start date: January 2004
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• 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 examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET).

Description:

As a consequence of periacetabular osteotomy the blood flow in acetabulum is decreased. After periacetabular osteotomy has been performed there is fine contact between the osteotomised acetabulum and the rest of the pelvis and the potential for healing is good. However, it has not been investigated how much the blood flow in acetabulum is changed after surgery. The blood flow is considered to be vital for how the pelvis heals after surgery. Most likely, the blood flow is important in relation to which degree osteoarthritis can be prevented after periacetabular osteotomy.

It is possible to estimate the blood flow by Positron Emission Tomography of the dysplastic hip joint pre- and postoperatively. In this study the blood flow and fluoride uptake is quantified by Positron emission tomography based on measurements of O-15 water and F-18 fluoride.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2009
• Est. primary completion date: January 2008
• 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.

• Informed consent.

Exclusion Criteria:

• Patients with neurological diseases

• Patients with calvé-Legg-Perthes syndrome.

• Patients where an femoral intertrochanteric osteotomy is necessary.

• Patients with medical sequelae after earlier hip surgery.

• Females who are pregnant.

• Patients with metal implants.

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Periacetabular osteotomy
osteotomy of the pelvis 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	changes in blood flow		within the first three weeks after operation	No
Secondary	fluoride uptake		within the first three weeks after operation	No