Kinematics Analysis of SIGMA® Partial Knee System

NCT ID: NCT02949336

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-19
• Study Completion Date: 2017-12-11

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.

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.

Conditions

Unicompartmental Knee Arthroplasty

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Observational use of fluoroscopy

Intervention Type: RADIATION

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.

Observational use of fluoroscopy

Intervention Type: RADIATION

Minimal radiation exposure (0.17 mSv) for observational purpose

Interventions

Observational use of fluoroscopy

Minimal radiation exposure (0.17 mSv) for observational purpose

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schulthess Klinik

OTHER

Sponsor Role: collaborator

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

Gelenkzentrum Zurich

UNKNOWN

Sponsor Role: collaborator

Stephen Ferguson

OTHER

Sponsor Role: lead

Responsible Party

Stephen Ferguson

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen Ferguson, Prof. Dr.

Role: STUDY_DIRECTOR

Institute for Biomechanics, ETH Zurich

Locations

Institute for Biomechanics, ETH Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

UKA V 2.4 02.09.2016

Identifier Type: -

Identifier Source: org_study_id