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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
History of Changes

July 5, 2005
September 16, 2009
January 2004
January 2008   (final data collection date for primary outcome measure)
changes in blood flow [ Time Frame: within the first three weeks after operation ] [ Designated as safety issue: No ]
changes in blood flow
Complete list of historical versions of study NCT00119444 on ClinicalTrials.gov Archive Site
fluoride uptake [ Time Frame: within the first three weeks after operation ] [ Designated as safety issue: No ]
fluoride uptake
Not Provided
Not Provided
 
Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography
Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

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

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
Procedure: Periacetabular osteotomy
osteotomy of the pelvis to increase acetabular coverage
Other Name: PAO
periacetabular osteotomy
Intervention: Procedure: Periacetabular osteotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2009
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00119444
20050606
No
Inger Mechlenburg, PhD, Aarhus Universityhospital
University of Aarhus
Not Provided
Principal Investigator: Kjeld Søballe, MD, Prof. Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
University of Aarhus
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP