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Prospective Clinical Evaluation of Three Prosthesis Re-Cap, M2a-Magnum and C2a-Taper.
This study is currently recruiting participants.
Verified by Frederiksberg University Hospital, September 2006
Sponsored by: Frederiksberg University Hospital
Information provided by: Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00284674
  Purpose

This evaluation is being conducted to evaluate the performance of thee prosthesis.


Condition Intervention Phase
Patients Undergoing a THR
Device: Hip prosthesis (re-cap, m2a-magnum and C2a-taper)
Phase IV

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284674

Contacts
Contact: Arne Borgwardt, M.D. 004538163450 arne@borgwardt.com

Locations
Denmark, Frederiksberg
Frederiksberg University Hospital Recruiting
Copenhagen, Frederiksberg, Denmark, 2000
Contact: Arne Borgwardt, M.D.     004538163450     Arne@borgwardt.com    
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
Study Director: Arne Borgwardt, M.D. Frederiksberg University Hospital
  More Information

Study ID Numbers: KF-01-287.591
Study First Received: January 31, 2006
Last Updated: September 14, 2006
ClinicalTrials.gov Identifier: NCT00284674  
Health Authority: Denmark: Ethics Committee

ClinicalTrials.gov processed this record on January 16, 2009