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Establish Implant Accuracy With X-PSI Knee System

NCT03275246 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-10-06

Study results available
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Summary

The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical alignment and compare them with preoperative planning imaging data. Mechanical alignment in the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared with results reported in the literature using a conventional (non-guided) approach.

Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to mechanical alignment as with conventional instrumentation.

Conditions

Interventions

DEVICE

X-PSI Knee System

Patients are operated with X-PSI Knee System guides

Sponsors & Collaborators

  • Zimmer, GmbH

    lead INDUSTRY

Principal Investigators

  • Oliver Schaetti, PhD · Jr. Clinical Project Lead

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-05
Primary Completion
2019-12-20
Completion
2020-11-17

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

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 NCT03275246 on ClinicalTrials.gov