NCT00119977

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 12, 2008

Status Verified

January 1, 2008

Enrollment Period

4.2 years

First QC Date

July 5, 2005

Last Update Submit

January 31, 2008

Conditions

Osteoarthritis

Keywords

cartilage thicknessRSADEXAultra soundMRIosteoarthritisperiacetabular osteotomy

Outcome Measures

Primary Outcomes (1)

  • migration of acetabulum

    six months

Secondary Outcomes (3)

  • BMD in acetabulum

    within two and a half year

  • status of labrum

    three years after pelvic osteotomy

  • changes in cartilage thickness

    two and half a year

Study Arms (1)

1

ACTIVE COMPARATOR
Procedure: 1 Periacetabular osteotomy

Interventions

1 Periacetabular osteotomyPROCEDURE

pelvic osteotomy to increase acetabular coverage

Also known as: periacetabular osteotomy
1

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 region
  • Informed consent

You may not qualify if:

  • 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

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 Professor

    Orthopaedic Center, Aarhus University Hospital, Aarhus Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2005

First Posted

July 14, 2005

Study Start

October 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 12, 2008

Record last verified: 2008-01

Locations

DK(1)