Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00119444
First received: July 5, 2005
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET).


Condition Intervention
Osteoarthritis
Procedure: Periacetabular osteotomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • changes in blood flow [ Time Frame: within the first three weeks after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fluoride uptake [ Time Frame: within the first three weeks after operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: January 2004
Study Completion Date: August 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
periacetabular osteotomy Procedure: Periacetabular osteotomy
osteotomy of the pelvis to increase acetabular coverage
Other Name: PAO

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119444

Locations
Denmark
Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kjeld Søballe, MD, Prof. Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Inger Mechlenburg, PhD, Aarhus Universityhospital
ClinicalTrials.gov Identifier: NCT00119444     History of Changes
Other Study ID Numbers: 20050606
Study First Received: July 5, 2005
Last Updated: September 16, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
PET
Periacetabular osteotomy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014