Clinical Trial: Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

This study is currently recruiting patients.

Sponsored by: University of Aarhus
Information provided by: University of Aarhus

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

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: changes in blood flow
Secondary Outcomes: fluoride uptake
Expected Total Enrollment:  14

Study start: January 2004;  Expected completion: July 2007
Last follow-up: July 2006;  Data entry closure: August 2006

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   -   60 Years,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00119444

Inger B Mechlenburg, MScience      65371093  Ext. 45    INGER.MECHLENBURG@KI.AU.DK
Kjeld Søballe, MD, Prof.      89497425  Ext. 45    OVL09@as.aaa.dk

Denmark
      Orthopaedic Center, Aarhus University Hospital, Aarhus,  8000,  Denmark; Recruiting
Inger B Mechlenburg, MScience  65371093  Ext. 45    INGER.MECHLENBURG@KI.AU.DK 
Inger B Mechlenburg, MScience,  Sub-Investigator
Kjeld Søballe, MD, Prof.,  Principal Investigator
Flemming Hermansen, MD,  Sub-Investigator
Jørgen Baas, MD,  Sub-Investigator

Study chairs or principal investigators

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

More Information

Study ID Numbers:  20050606
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 12, 2005
ClinicalTrials.gov Identifier:  NCT00119444
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2005-07-26

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