Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01102829
• Lead Sponsor: Leiden University Medical Center

Brief Summary

The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-12
• Last Update Submitted: 2010-04-12
• Study First Posted: 2010-04-13
• Last Update Posted: 2010-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Patient is diagnosed with osteoarthritis and requiring primary arthroplasty
• Patient is capable of giving informed consent and expressing a willingness to comply with this study
• Patient has no major deformities
• The ability to perform a lunge and step-up motion without the help of bars or a cane.
• No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989)

Exclusion Criteria

• The patient is unable or unwilling to sign the Informed Consent specific to this study
• The individual has a functional impairment of any other lower extremity joint besides the operated knee
• Patient has a flexion contracture of more than 15°
• Patient has a varus/valgus contracture of more than 15°
• Patients requiring revision arthroplasty
• The patient does not understand the Dutch or English language good enough to participate.
• The use of walking aids
• The inability to walk more than 500 meters

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Migration	24 months post-operatively	Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.

Secondary Outcome Measures

Name	Time	Method
anterior-posterior translation patterns	6 months post-operatively	Fluoroscopy was used to determine the anterior-posterior translation patterns of the femoral component with respect to the tibial component.
Axial rotation patterns	6 months post-operatively	Fluoroscopy was used to determine the axial rotation patterns of both the insert and the femoral component with respect to the tibial component
Muscle activity	6 months post-operatively	Bipolar surface EMG data of the flexor and extensor muscles is collected.
Shear forces	6 months post-operatively	A force plate is used to measure the ground reaction forces which can be used to calculate the shear forces.

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands