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Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

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ClinicalTrials.gov Identifier: NCT00249054
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Arne Borgwardt, Frederiksberg University Hospital

Brief Summary:

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


Condition or disease Intervention/treatment
Patients Suitable for THA Device: ASR hip prosthesis Device: ReCap hip prosthesis

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
Study Start Date : November 2005
Primary Completion Date : November 2012

Arm Intervention/treatment
Active Comparator: ASR hip prosthesis
DuPuy ASR hip prosthesis
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: ReCap hip prosthesis
Biomet ReCap hip prosthesis
Device: ReCap hip prosthesis
Implantation of resurfacing prosthesis
Other Name: Biomet ReCap hip prosthesis



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Arne Borgwardt, Head of Dpt, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00249054     History of Changes
Other Study ID Numbers: KF11279577
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017