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Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT00249054
First received: November 3, 2005
Last updated: March 22, 2017
Last verified: March 2017
November 3, 2005
March 22, 2017
November 2005
November 2012   (Final data collection date for primary outcome measure)
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up. [ Time Frame: 10 year follow up ]
follow with intervals of 1 to 3 years for determination of function and prosthesis survival
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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 and ReCap Resurfacing Arthroplasty
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.

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: Strength, gait analysis, range of motion. Scanning: DEXA and MRI

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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Patients Suitable for THA
  • Device: ASR hip prosthesis
    Implantation of resurfacing prosthesis
    Other Name: DuPuy ASR hip prosthesis
  • Device: ReCap hip prosthesis
    Implantation of resurfacing prosthesis
    Other Name: Biomet ReCap hip prosthesis
  • Active Comparator: ASR hip prosthesis
    DuPuy ASR hip prosthesis
    Interventions:
    • Device: ASR hip prosthesis
    • Device: ReCap hip prosthesis
  • Active Comparator: ReCap hip prosthesis
    Biomet ReCap hip prosthesis
    Intervention: Device: ReCap hip prosthesis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
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November 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00249054
KF11279577
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Arne Borgwardt, Frederiksberg University Hospital
Frederiksberg University Hospital
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Study Director: arne borgwardt, M.D. Frederiksberg University Hospital
Frederiksberg University Hospital
March 2017

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