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Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

NCT00249054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-03-24

No results posted yet for this study

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

Conditions

  • Patients Suitable for THA

Interventions

DEVICE

ASR hip prosthesis

Implantation of resurfacing prosthesis

DEVICE

ReCap hip prosthesis

Implantation of resurfacing prosthesis

Sponsors & Collaborators

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • arne borgwardt, M.D. · Frederiksberg University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2012-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00249054 on ClinicalTrials.gov