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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284674
First Posted: February 1, 2006
Last Update Posted: March 24, 2017
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.
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital
  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
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284674


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

Responsible Party: Arne Borgwardt, MD, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00284674     History of Changes
Other Study ID Numbers: KF-01-287.591
First Submitted: January 31, 2006
First Posted: February 1, 2006
Last Update Posted: March 24, 2017
Last Verified: March 2017