Standard Test Method for Determination of Total Knee Replacement Constraint
|Publication Date:||10 April 2003|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
The purpose of this test method is to establish a database of total knee replacement (TKR) motion characteristics with the intent of developing guidelines for the assignment of constraint criteria to TKR designs. (See the Rationale in Appendix X1.)
This test method covers the means by which a TKR constraint may be quantified according to motion delineated by the inherent articular design as determined while under specific loading conditions in an in vitro environment.
Tests deemed applicable to the constraint determination are antero-posterior draw, medio-lateral shear, rotary laxity, valgus-varus rotation, and distraction, as applicable. Also covered is the identification of geometrical parameters of the contacting surfaces which would influence this motion and the means of reporting the test results. (See Practices E 4.)
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.