Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

November 19, 2015 updated by: University of Aarhus
The purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Orthopaedic Center, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: periacetabular osteotomy
Procedure: Periacetabular osteotomy
osteotomy of the pelvis to increase acetabular coverage
Other Names:
  • PAO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in blood flow
Time Frame: within the first three weeks after operation
within the first three weeks after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
fluoride uptake
Time Frame: within the first three weeks after operation
within the first three weeks after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Kjeld Søballe, MD, Prof., Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 5, 2005

First Submitted That Met QC Criteria

July 5, 2005

First Posted (Estimate)

July 13, 2005

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050606

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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