Skip to main content
OpenTrials
Completed

NCT Number: NCT02949336

Kinematics Analysis of SIGMA® Partial Knee System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Unicompartmental Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Biomechanics, ETH Zurich

Zurich, Canton of Zurich, 8093, Switzerland

About this study

The knee arthroplasty for each patient was implanted more than one year ago as per inclusion criteria of this study with the sole purpose of standard clinical practice of the recruiting surgeons.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(group 1):

  • medial SIGMA® High Performance Partial Knee System due to medial OA
  • Intact/functional ACL
  • BMI ≤ 32
  • good clinical outcome, KOOS >70
  • no or very low pain VAS < 2
  • Follow-up at least one year post-op
  • Standardized general health survey score (SF-12) within the normal range for people in their age group
  • Age ≥ 18 years

Exclusion criteria

(group 1):

  • Actual significant problem on lower extremities
  • Misaligned UKA
  • Deficient / non-functional ACL (Lachman Test)
  • Any other arthroplasty at the lower extremities
  • Patient incapable to understand and sign informed consent
  • Incapable of performing the motion tasks
  • Pregnancy

Inclusion criteria

(group 2):

  • medial SIGMA® High Performance Partial Knee System due to medial OA
  • Deficient / non-functional ACL
  • Central to posterior wear of medial tibial plateau (pre-op MRI)
  • 50% reduced tibial posterior slope after UKA (post-op radiograph)
  • BMI ≤ 32
  • good clinical outcome, KOOS >70
  • no or very low pain VAS < 2
  • Follow-up at least one year post-op
  • Standardized general health survey score (SF-12) within the normal range for people in their age group
  • Age ≥ 18 years

Exclusion criteria

(group 2):

  • Actual significant problem on lower extremities
  • Misaligned UKA / non-reduced posterior tibial slope (post-op radiograph)
  • Intact / functional ACL
  • Any other arthroplasty at the lower extremities
  • Patient incapable to understand and sign informed consent
  • Incapable of performing the motion tasks
  • Pregnancy

Treatment and study plan

Observational use of fluoroscopy

Radiation

Minimal radiation exposure (0.17 mSv) for observational purpose

Primary outcomes

  1. Knee Kinematics

    Time frame: 3 hours

    The primary outcome of this study is the relationship between the knee flexion angle and the medial and lateral anterior-posterior translation of the condyles 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.

Sponsors and collaborators

Lead sponsor

Stephen Ferguson

Other

Collaborators

  • DePuy Synthes
  • Gelenkzentrum Zurich
  • Schulthess Klinik

Registry information

Official study title

Kinematics Analysis: Traditional (ACL Retaining) and ACL Deficient (Reduced Tibial Slope) Medial, Fixed Bearing Primary Unicondylar Knee Arthroplasty With the SIGMA® High Performance Partial Knee System

Acronym: UKA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.