NCT01657357

Brief Summary

Follow up study of patients, who despite periacetabular osteotomy, need a total hip arthroplasty, to see outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

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, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

March 13, 2012

Last Update Submit

January 30, 2013

Conditions

Hip DysplasiaOsteotomy of PelvisTotal Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Does previous PAO compromise the function of a secondary THA

    To describe the radiographic status (ex. cup positioning, calcifications, signs of loosing etc) of the THA, the physical function of the THA ( Harris Hip Score), and pt reported outcome measurements (SF36 and WOMAC).

    Up to 10 years after THA surgery

Study Arms (1)

PAO, osteoarhritis, THA

Other: Routine followup

Interventions

Routine followupOTHER

questionnaires

PAO, osteoarhritis, THA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients, who despite a joint preserving procedure(periacetabular osteotomy PAO) ended up with a total hip arthroplasty (THA).

You may qualify if:

  • PAO and THA

You may not qualify if:

  • time since THA less than 4 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department, Aarhus Universityhospital

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Study Officials

  • Kjeld Soballe, Prof. D.Msc

    Orthopedic Research Unit, Aarhus University Hospital

    STUDY CHAIR

  • Charlotte Hartig-Andreasen, MD

    Orthopedic Research Unit, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

August 6, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

DK(1)