Kinematics Analysis of SIGMA® Partial Knee System (UKA)

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

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.

Study Overview

• Status: Completed
• Conditions: Unicompartmental Knee Arthroplasty
• Intervention / Treatment: Radiation: Observational use of fluoroscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8093
      • Institute for Biomechanics, ETH Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The clinical investigators of the participating clinics (PD Dr. med. Fabian von Knoch, Gelenkzentrum Zürich; and Dr. med. Stefan Preiss, Schulthess Klinik) will identify potential subjects based on clinical records. PD Dr. med. Fabian von Knoch will recruit patients he operated on at the Gelenkzentrum Zürich while Dr. med. Stefan Preiss will recruit subjects from his patient population at the Schulthess Klinik.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Traditional UKA; Patients with a traditional Medial Unicompartmental Knee Arthroplasty, SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) will undergo observational use of fluoroscopy to analyze joint kinematics	Radiation: Observational use of fluoroscopy; Minimal radiation exposure (0.17 mSv) for observational purpose
Group 2: ACL deficient UKA; 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 will undergo observational use of fluoroscopy to analyze joint kinematics.	Radiation: Observational use of fluoroscopy; Minimal radiation exposure (0.17 mSv) for observational purpose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Kinematics	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.	3 hours

Collaborators and Investigators

• Sponsor: Stephen Ferguson
• Collaborators: Schulthess Klinik; DePuy Synthes; Gelenkzentrum Zurich
• Investigators: Study Director: Stephen Ferguson, Prof. Dr., Institute for Biomechanics, ETH Zürich

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2016
• Primary Completion (Actual): September 11, 2017
• Study Completion (Actual): December 11, 2017

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UKA V 2.4 02.09.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided