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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

November 3, 2005
July 3, 2007
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Complete list of historical versions of study NCT00249054 on ClinicalTrials.gov Archive Site
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Prospective Clinical Evaluation of ASR Resurfacing Arthroplasty
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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

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Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Patients Suitable for THA
Device: ASR (THA)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00249054
KF11279577
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Frederiksberg University Hospital
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Study Director: arne borgwardt, M.D. Frederiksberg University Hospital
Frederiksberg University Hospital
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP