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Bimetric-10: Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-Metric Stem

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00192699
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date September 11, 2005
First Posted Date September 19, 2005
Last Update Posted Date March 31, 2014
Study Start Date January 2004
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bimetric-10: Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-Metric Stem
Official Title 10 Year Follow-up Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-metric Stem
Brief Summary This is a 10 year follow-up investigation of patients who have underwent total hip arthroplasty with a cemented Bimetric stem.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with osteoarthrosis in hip who have underwent surgery for 10 years ago using Cemented Bi-Metric femoral stem.
Condition Osteoarthrosis
Intervention Device: Bimetric femoral stem
Cemented Bi-Metric femoral stem
Other Name: Cemented Bi-Metric femoral stem
Study Groups/Cohorts Group 1: Cemented Bi-Metric femoral stem
Cemented Bi-Metric femoral stem
Intervention: Device: Bimetric femoral stem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October¬†17,¬†2012)
80
Original Enrollment Not Provided
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • Osteoarthrosis

Exclusion criteria:

  • Malignancies
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00192699
Other Study ID Numbers ON-04-008b-JPE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Northern Orthopaedic Division, Denmark
Original Responsible Party Not Provided
Current Study Sponsor Northern Orthopaedic Division, Denmark
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Mogens B Laursen, MD, PhD Northern Orthopaedic Division, Aalborg University Hospital, Denmark
PRS Account Northern Orthopaedic Division, Denmark
Verification Date March 2014