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Prospective Clinical Evaluation of ASR Resurfacing Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Frederiksberg University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00249054
First received: November 3, 2005
Last updated: July 3, 2007
Last verified: July 2007
History of Changes
  Purpose

This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:

Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.

Biopsies: Metal ions, cytokines and histology. Biomechanics: Streght, gait analysis, range of motion. Scanning: DEXA and MRI


Condition Intervention Phase
Patients Suitable for THA
 Device: ASR (THA)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Frederiksberg University Hospital:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ASA I-II,DEXA-scanning:

  • lower limit for a 55 years old women,
  • MRI normal
  • vitality in caput
  • willing to return for follow-up evaluations.

Exclusion Criteria:

  • collum femoris < 2 cm
  • large cysts in caput (> 1 cm)
  • mismatch between caput and acetabulum
  • caput necrosis
  • treatment with medicine which affects bone metabolism
  • impaired kidney function.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249054

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

No publications provided

ClinicalTrials.gov Identifier: NCT00249054     History of Changes
Other Study ID Numbers: KF11279577
Study First Received: November 3, 2005
Last Updated: July 3, 2007
Health Authority: Denmark: De Videnskabsetiske Komit'eer for Københavns og Frederiksberg Kommune

ClinicalTrials.gov processed this record on May 23, 2013