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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
  Purpose

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 Intervention
Patients Suitable for THA Device: ASR hip prosthesis Device: ReCap hip prosthesis

Study Type: Interventional
Study Design: 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.

Further study details as provided by Arne Borgwardt, Frederiksberg University Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 46
Study Start Date: November 2005
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Arne Borgwardt, Head of Dpt, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT00249054     History of Changes
Other Study ID Numbers: KF11279577
Study First Received: November 3, 2005
Last Updated: March 22, 2017

ClinicalTrials.gov processed this record on August 23, 2017