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Prospective Clinical Evaluation of ASR Resurfacing Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Frederiksberg University Hospital.
Recruitment status was:  Active, not recruiting
Information provided by:
Frederiksberg University Hospital Identifier:
First received: November 3, 2005
Last updated: July 3, 2007
Last verified: July 2007

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:


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

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
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Please refer to this study by its identifier: NCT00249054

Frederiksberg University Hospital
Frederiksberg, Copenhagen, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Study Director: arne borgwardt, M.D. Frederiksberg University Hospital
  More Information Identifier: NCT00249054     History of Changes
Other Study ID Numbers: KF11279577 
Study First Received: November 3, 2005
Last Updated: July 3, 2007 processed this record on February 20, 2017