NCT01443975

Brief Summary

The purpose of this study is to clinically evaluate the use of the x-pander device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

2 active sites

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

September 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

September 29, 2011

Last Update Submit

March 28, 2014

Conditions

OsteoarthrosisTotal Hip Arthroplasty

Keywords

Total Hip ArthroplastyOsteoarthritis

Study Arms (1)

All patients

Measurement with x-pander in acetabulum prior to inserting the artificial hip socket.

Procedure: x-pander

Interventions

x-panderPROCEDURE

Measurement of the size and quality of the bony acetabulum before mounting the artificial hip socket.

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients for primary THA

You may qualify if:

  • Clinical diagnosis for hip osteoarthrosis

You may not qualify if:

  • Previous surgery of the actual hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ortopaedic Clinic

Farsoe Hospital, Aalborg University Hospital, 9640, Denmark

Location

Ortopaedic Clinic

Frederikshavn Hospital, Aalborg University Hospital, 9900, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Mogens B. Laursen, MD, PhD

    Orthopaedic Surgery Research Unit, Aalborg Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 29, 2011

First Posted

September 30, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

DK(2)