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Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.

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ClinicalTrials.gov Identifier: NCT00284674
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 1, 2006
Last Update Posted Date March 24, 2017
Actual Study Start Date  ICMJE March 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.
Official Title  ICMJE Not Provided
Brief Summary This evaluation is being conducted to evaluate the performance of thee prosthesis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Patients Undergoing a THR
Intervention  ICMJE Device: Hip prosthesis (re-cap, m2a-magnum and C2a-taper)
Study Arms  ICMJE Not Provided
Publications * Borgwardt A, Borgwardt L, Zerahn B, Daugaard H, Borgwardt L, Ribel-Madsen S. A Randomized Seven-Year Study on Performance of the Stemmed Metal M2a-Magnum and Ceramic C2a-Taper, and the Resurfacing ReCap Hip Implants. J Arthroplasty. 2018 May;33(5):1412-1420. doi: 10.1016/j.arth.2017.11.061. Epub 2017 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Good general health of age (ASA I-II)
  • DEXA-scanning: lower limit for a 55 years old man
  • MRI normal vitality in caput
  • Willing to return for follow-up evaluations
  • Exclusion Criteria:
  • Subjects displaying any of the following contra-indications shall be excluded from this evaluation:
  • Inability to co-operate with and complete the study
  • Collum < 2 cm
  • Large cysts in caput
  • Mismatch between caput acetabulum
  • Caput necrosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00284674
Other Study ID Numbers  ICMJE KF-01-287.591
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arne Borgwardt, Frederiksberg University Hospital
Study Sponsor  ICMJE Frederiksberg University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Arne Borgwardt, M.D. Frederiksberg University Hospital
PRS Account Frederiksberg University Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP