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Serologic Characterization of Bone-healing

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: NCT00377884
Recruitment Status : Withdrawn (Lack of patients, lack of funding for analysis)
First Posted : September 19, 2006
Last Update Posted : April 3, 2014
Sponsor:
Collaborator:
CCBR Clinical Research Center, Aalborg, Denmark
Information provided by:
Northern Orthopaedic Division, Denmark

Tracking Information
First Submitted Date September 18, 2006
First Posted Date September 19, 2006
Last Update Posted Date April 3, 2014
Study Start Date January 2004
Actual Primary Completion Date June 2009   (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 Serologic Characterization of Bone-healing
Official Title Serologic Based Molecular Characterization of Bone-healing After Cementless Total Hip Arthroplasty
Brief Summary Investigation of serologic bone markers in patients undergoing hip arthroplasty
Detailed Description Investigation of serologic bone markers in patients undergoing hip arthroplasty. Measured by frequent blood- and urine samples pre-operative and during the first post-operative year.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients planned for cementless THR for OA in the hip
Condition Arthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
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Recruitment Status Withdrawn
Actual Enrollment
 (submitted: October 29, 2013)
0
Original Enrollment
 (submitted: September 18, 2006)
30
Estimated Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Ages 40-80 years
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (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 NCT00377884
Other Study ID Numbers ON-04-018-MBL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Northern Orthopaedic Division, Orthopaedic Research Unit, Aarhus University - Aalborg Hospital, Denmark
Study Sponsor Northern Orthopaedic Division, Denmark
Collaborators CCBR Clinical Research Center, Aalborg, Denmark
Investigators
Principal Investigator: Mogens B Laursen, MD, Phd Northern Orthopaedic Division
PRS Account Northern Orthopaedic Division, Denmark
Verification Date April 2014