We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00249054
First Posted: November 7, 2005
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital
November 3, 2005
November 7, 2005
March 24, 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
Not Provided
Complete list of historical versions of study NCT00249054 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
Not Provided
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
Not Provided
Not Provided
Not Provided
Arne Borgwardt, Frederiksberg University Hospital
Frederiksberg University Hospital
Not Provided
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