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

This study has been completed.
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital Identifier:
First received: January 31, 2006
Last updated: March 22, 2017
Last verified: March 2017
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Further study details as provided by Arne Borgwardt, Frederiksberg University Hospital:

Actual Study Start Date: March 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00284674

Frederiksberg University Hospital
Copenhagen, Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Study Director: Arne Borgwardt, M.D. Frederiksberg University Hospital
  More Information

Responsible Party: Arne Borgwardt, MD, Frederiksberg University Hospital Identifier: NCT00284674     History of Changes
Other Study ID Numbers: KF-01-287.591
Study First Received: January 31, 2006
Last Updated: March 22, 2017 processed this record on September 19, 2017