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Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

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ClinicalTrials.gov Identifier: NCT00119444
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Periacetabular osteotomy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography
Study Start Date : January 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
periacetabular osteotomy Procedure: Periacetabular osteotomy
osteotomy of the pelvis to increase acetabular coverage
Other Name: PAO



Primary Outcome Measures :
  1. changes in blood flow [ Time Frame: within the first three weeks after operation ]

Secondary Outcome Measures :
  1. fluoride uptake [ Time Frame: within the first three weeks after operation ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00119444     History of Changes
Other Study ID Numbers: 20050606
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: September 2009

Keywords provided by University of Aarhus:
PET
Periacetabular osteotomy

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