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

Rheumatoid Arthritis Clinical Trial

— ROCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102829
• Other study ID #: ROCC
• Status: Completed
• Phase: N/A
• First received: April 9, 2010
• Last updated: April 12, 2010
• Start date: September 2007
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration	Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.	24 months post-operatively	No
Secondary	anterior-posterior translation patterns	Fluoroscopy was used to determine the anterior-posterior translation patterns of the femoral component with respect to the tibial component.	6 months post-operatively	No
Secondary	Axial rotation patterns	Fluoroscopy was used to determine the axial rotation patterns of both the insert and the femoral component with respect to the tibial component	6 months post-operatively	No
Secondary	Muscle activity	Bipolar surface EMG data of the flexor and extensor muscles is collected.	6 months post-operatively	No
Secondary	Shear forces	A force plate is used to measure the ground reaction forces which can be used to calculate the shear forces.	6 months post-operatively	No