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

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ClinicalTrials.gov Identifier: NCT00284674
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital

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

Condition or disease Intervention/treatment Phase
Patients Undergoing a THR Device: Hip prosthesis (re-cap, m2a-magnum and C2a-taper) Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Actual Study Start Date : March 2006
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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
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Denmark
Frederiksberg University Hospital
Copenhagen, Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
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Study Director: Arne Borgwardt, M.D. Frederiksberg University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arne Borgwardt, MD, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00284674    
Other Study ID Numbers: KF-01-287.591
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017