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Dynamic Congruence Total Knee Replacement vs Posterior-stabilized

NCT04524312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-09-29

No results posted yet for this study

Summary

This study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen with posterior stabilization and Bioimplanti K-Mod cruciate-retaining with dynamic congruence

Conditions

  • Osteo Arthritis Knee
  • Surgery
  • Joint Diseases

Interventions

PROCEDURE

Total knee replacement

Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant

DIAGNOSTIC_TEST

Biomechanics

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

DEVICE

NexGen Ps or Bioimplanti K-MOD implant

Participant are randomly allocated to receive one of the NexGen PS or Biomplanti K-MOD total knee implant for treatment of end-stage knee osteoarthritis.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Bartosz M. Maciąg, MD · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-09-26
Completion
2020-09-26

Countries

  • Poland

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 NCT04524312 on ClinicalTrials.gov