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Clinical Trials/NCT00249054
NCT00249054
Completed
N/A

Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.

Frederiksberg University Hospital1 site in 1 country46 target enrollmentNovember 2005
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ConditionsPatients Suitable for THA

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patients Suitable for THA
Sponsor
Frederiksberg University Hospital
Enrollment
46
Locations
1
Primary Endpoint
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
November 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Frederiksberg University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Arne Borgwardt

Head of Dpt

Frederiksberg University Hospital

Eligibility 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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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