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Roentgen Stereophotogrammetric Analysis (RSA) to Evaluate Fixation of Biofoam Advance Total Knee Arthroplasty Components

NCT00657956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-03-31

No results posted yet for this study

Summary

Hip and knee replacement arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a hip or knee arthroplasty is finite. This fact has largely been responsible for the continued development of new devices and techniques for joint arthroplasty surgery. Unfortunately, the introduction of new technologies and devices is not a benign process, and even subtle changes to existing implants can have a disastrous effect on patient outcome. The fact that new technologies and devices can lead to poor results has led some authors to advocate a phased introduction of new technologies. A key component of the phased introduction approach advocates the use of roentgen stereophotogrammetric analysis (RSA) early in the testing process. RSA is a highly accurate radiographic technique developed in Lund, Sweden and has for some time been the gold standard in Europe for assessing the stability of implants within bone. The purpose of this study is to utilize RSA to elucidate the migration patterns of the foam metal backed Advance Knee Arthroplasty components during the first 2 years postoperatively and to determine in what proportion of cases adequate fixation is achieved. In addition outcome measures will be recorded to quantify changes in functional status of subjects after surgery and bone mineral density will be monitored to quantify bone in-growth around the implant. Migration patterns will be compared to results obtained from previous studies of uncemented and cemented total knee arthroplasty components conducted at this centre.

Conditions

Interventions

DEVICE

Advance Biofoam porous metal backed tibial component with or without screw augmentation

total knee arthroplasty tibial component that has a backing of porous titanium metal to facilitate bone in-growth

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    collaborator INDUSTRY

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Michael Gross, MD · Dalhousie University

  • Michael J Dunbar, MD PhD · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Canada

Study Locations

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Entities

Diseases

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 NCT00657956 on ClinicalTrials.gov