Periacetabular Osteotomy.A Prospective Study With Referen... | NCT00119977

Studies
Periacetabular Osteotomy.A Prospective Study With Reference to Cartilage, Migration and Bone Density

NCT00119977

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Feb 12, 2008Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

1 Periacetabular osteotomy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jul 5, 2005

First Submission Date that Met QC Criteria

Jul 5, 2005

First Posted Date

Jul 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2008

Last Update Posted Date

Feb 12, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Procedure: 1 Periacetabular osteotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1 Periacetabular osteotomy	Procedure	pelvic osteotomy to increase acetabular coverage	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
migration of acetabulum		six months

Secondary Outcomes

Measure	Description	Time Frame
BMD in acetabulum		within two and a half year
status of labrum		three years after pelvic osteotomy
changes in cartilage thickness

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kjeld Søballe, MD Professor	Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic Center, Aarhus University Hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided