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A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement

NCT01194817 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-24

No results posted yet for this study

Summary

The purpose of this study is to compare the the Nexgen knee replacement system using cementless fixation with the same system using cemented fixation. At minimum 2-year follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and cemented fixation will demonstrate no differences in clinical outcome based on Oxford and Knee Society scores, patient-assessed visual analog pain, clinical complications, radiographic fixation and implant survivorship.

Conditions

Interventions

DEVICE

High-Flexion Knee Replacement System using Cemented Fixation

DEVICE

High-Flexion Knee Replacement System using Cementless Fixation

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Anderson Orthopaedic Research Institute

    lead OTHER

Principal Investigators

  • Kevin B Fricka, MD · Anderson Orthopaedic Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2026-12-31
Completion
2026-12-31

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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 NCT01194817 on ClinicalTrials.gov