Text Size

Prospective Clinical Evaluation of Three Prosthesis Re-Cap, M2a-Magnum and C2a-Taper.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Frederiksberg University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00284674
First received: January 31, 2006
Last updated: September 14, 2006
Last verified: September 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Further study details as provided by Frederiksberg University Hospital:

  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 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

No publications provided

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

ClinicalTrials.gov processed this record on May 22, 2013