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Prospective Randomized Study of Cementless vs Cemented UKA

NCT05377450 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-03-26

No results posted yet for this study

Summary

To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Engage Partial Knee

Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system with bone cement.

DEVICE

Engage Partial Knee

Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system without bone cement.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    collaborator INDUSTRY

  • JIS Research Institute

    lead OTHER

Principal Investigators

  • David A Crawford, MD · JIS Research Institute

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
2022-08-29
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

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 NCT05377450 on ClinicalTrials.gov