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

This study has been completed.
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00284674
First received: January 31, 2006
Last updated: March 17, 2015
Last verified: September 2006
  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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

ClinicalTrials.gov Identifier: NCT00284674     History of Changes
Other Study ID Numbers: KF-01-287.591 
Study First Received: January 31, 2006
Last Updated: March 17, 2015
Health Authority: Denmark: Ethics Committee

ClinicalTrials.gov processed this record on July 21, 2016