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Kinematics Analysis of SIGMA® Partial Knee System

NCT02949336 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2019-01-23

No results posted yet for this study

Summary

The proposed study is a prospective collection of health related personal data (observational study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich. The UKA subjects are recruited based on the inclusion and exclusion criteria.

The primary objective is to quantify and describe the three-dimensional kinematics for patients with a traditional medial SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) during these daily activities.

The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee.

Conditions

  • Unicompartmental Knee Arthroplasty

Interventions

RADIATION

Observational use of fluoroscopy

Minimal radiation exposure (0.17 mSv) for observational purpose

Sponsors & Collaborators

  • Schulthess Klinik

    collaborator OTHER

  • DePuy Synthes

    collaborator INDUSTRY

  • Gelenkzentrum Zurich

    collaborator UNKNOWN

  • Stephen Ferguson

    lead OTHER

Principal Investigators

  • Stephen Ferguson, Prof. Dr. · Institute for Biomechanics, ETH Zurich

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2017-09-11
Completion
2017-12-11

Countries

  • Switzerland

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 NCT02949336 on ClinicalTrials.gov