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

Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01102829

Acronym

ROCC

Enrollment

Registered

2010-04-13

Start date

2007-09-30

Completion date

2010-04-30

Last updated

2010-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Knee Joint, Arthroplasty, Replacement, Knee

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Netherlands

Outcome results