NCT00119444

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 20, 2015

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

July 5, 2005

Last Update Submit

November 19, 2015

Conditions

Osteoarthritis

Keywords

PETPeriacetabular osteotomy

Outcome Measures

Primary Outcomes (1)

  • changes in blood flow

    within the first three weeks after operation

Secondary Outcomes (1)

  • fluoride uptake

    within the first three weeks after operation

Study Arms (1)

periacetabular osteotomy

OTHER
Procedure: Periacetabular osteotomy

Interventions

Periacetabular osteotomyPROCEDURE

osteotomy of the pelvis to increase acetabular coverage

Also known as: PAO
periacetabular osteotomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Søballe, MD, Prof.

    Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2005

First Posted

July 13, 2005

Study Start

January 1, 2004

Primary Completion

January 1, 2008

Study Completion

August 1, 2009

Last Updated

November 20, 2015

Record last verified: 2009-09

Locations

DK(1)