Clinical Evaluation on the Use of the X-pander Device (X-Pander)

This study is currently recruiting participants.
Verified May 2013 by Northern Orthopaedic Division, Denmark
Sponsor:
Collaborator:
Company Medichanical Engineering
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01443975
First received: September 29, 2011
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Osteoarthrosis
Total Hip Arthroplasty
Procedure: x-pander

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation on the Use of the X-pander Device

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients
Measurement with x-pander in acetabulum prior to inserting the artificial hip socket.
Procedure: x-pander
Measurement of the size and quality of the bony acetabulum before mounting the artificial hip socket.

Detailed Description:

Clinical evaluation on the use of the x-pander device during THA-surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all patients for primary THA

Criteria

Inclusion Criteria:

  • Clinical diagnosis for hip osteoarthrosis

Exclusion Criteria:

  • Previous surgery of the actual hip
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443975

Locations
Denmark
Ortopaedic Clinic Recruiting
Farsoe Hospital, Aalborg University Hospital, Denmark, 9640
Contact: Mogens B Laursen, M.D., PhD     +4520946846     mogens.berg.laursen@rn.dk    
Ortopaedic Clinic Recruiting
Frederikshavn Hospital, Aalborg University Hospital, Denmark, 9900
Contact: Mogens B Laursen, M.D., PhD     +4520946846     mogens.berg.laursen@rn.dk    
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Company Medichanical Engineering
Investigators
Principal Investigator: Mogens B. Laursen, MD, PhD Orthopaedic Surgery Research Unit, Aalborg Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01443975     History of Changes
Other Study ID Numbers: N-20110043
Study First Received: September 29, 2011
Last Updated: May 1, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Northern Orthopaedic Division, Denmark:
Total Hip Arthroplasty
Osteoarthritis

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013