Kinematics Analysis of SIGMA® Partial Knee System

NCT02949336 | Completed

• 1 other identifier: UKA V 2.4 02.09.2016
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Observational use of fluoroscopy RADIATION

Minimal radiation exposure (0.17 mSv) for observational purpose

Group 1: Traditional UKA; Group 2: ACL deficient UKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• % 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

Sponsors & Collaborators

• Stephen Ferguson: lead
• Schulthess Klinik: collaborator
• DePuy Synthes: collaborator
• Gelenkzentrum Zurich: collaborator

Study Sites (1)

Institute for Biomechanics, ETH Zurich

Zurich, Canton of Zurich, 8093, Switzerland

Location

Study Officials

• Stephen Ferguson, Prof. Dr.

  Institute for Biomechanics, ETH Zurich

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 31, 2016
• Study Start: December 19, 2016
• Primary Completion: September 11, 2017
• Study Completion: December 11, 2017
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

CH (1)