Periacetabular Osteotomy.A Prospective Study With Reference to Cartilage, Migration and Bone Density - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00119977

Purpose

The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia.

Condition	Intervention
Osteoarthritis	Procedure: 1 Periacetabular osteotomy

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Periacetabular Osteotomy. A Prospective Study With Reference to Cartilage, Migration and Bone Density

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

migration of acetabulum [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BMD in acetabulum [ Time Frame: within two and a half year ] [ Designated as safety issue: No ]
status of labrum [ Time Frame: three years after pelvic osteotomy ] [ Designated as safety issue: No ]
changes in cartilage thickness [ Time Frame: two and half a year ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	October 2003
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Procedure: 1 Periacetabular osteotomy pelvic osteotomy to increase acetabular coverage

Detailed Description:

The cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint contact pressures secondary to decreased acetabular coverage of the femoral head and/or incongruity of the articular surfaces. The investigators' hypothesis is that when periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has happened at the time periacetabular osteotomy is performed. Hence, the purposes of this study are:

to develop an unbiased and precise method for measurement of the thickness of the articular cartilage in the hip joint because such a method can be used to evaluate the effect of periacetabular osteotomy and also to give a more precise indication/contraindication for surgery;
to evaluate the migration of the acetabulum postoperatively and 6 months after surgery by use of RSA to examine the stability of the osteotomy; and
to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to find out whether the change in load distribution will affect bone density of the acetabulum over time in a way that in the area where more load is applied, bone density will increase, and in areas with less load, bone density will decrease;
to examine the labrum in the hip joint.

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 region
Informed consent

Exclusion Criteria:

Patients with neurological diseases
Patients with calvé-Legg-Perthes syndrome
Patients where a 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: NCT00119977

Locations

Denmark
Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Kjeld Søballe, MD Professor

Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark

More Information

No publications provided

Responsible Party:	Aarhus University Hospital ( Inger Mechlenburg, post doc. )
Study ID Numbers:	20050605
Study First Received:	July 5, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00119977 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

cartilage thickness
RSA
DEXA
ultra sound

MRI
osteoarthritis
periacetabular osteotomy

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 02, 2009