NCT01102829
Completed
N/A
Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA
Leiden University Medical Center1 site in 1 country11 target enrollmentSeptember 2007
ConditionsRheumatoid Arthritis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Leiden University Medical Center
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Migration
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Migration
Time Frame: 24 months post-operatively
Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.
Secondary Outcomes
- anterior-posterior translation patterns(6 months post-operatively)
- Axial rotation patterns(6 months post-operatively)
- Muscle activity(6 months post-operatively)
- Shear forces(6 months post-operatively)
Study Sites (1)
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