1.1 This practice is intended to provide guidance for the static and dynamic testing of spinous process plates (SPPs). The implants consist of parallel plates that are clamped around adjacent spinous processes and are intended to stabilize the motion segment for fusion. 1.2 This practice is not intended to address interspinous spacer devices for non-fusion. 1.3 This practice is intended to provide a basis for the mechanical comparison of past, present, and future SPPs. These test methods are intended to enable the user to compare devices mechanically and do not purport to provide performance standards for them. 1.4 This practice describes static and dynamic tests by specifying load types and specific methods of applying these loads. The tests for characterizing the performance of SPPs can include static and dynamic axial compression, static and dynamic torsion, static pull-off testing, and static and dynamic plate dissociation testing. 1.5 These test methods do not purport to address all clinically relevant failure modes for SPPs, some of which will be device specific. For example, these test methods do not fully address failures at the bone/implant interface (that is, spinous process fractures). 1.6 Multiple test methods are included in this practice. However, note that the user is not obligated to use all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In some instances, only a subset of the herein described test methods will be required. 1.7 Units--The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians. No other units of measurement are included in this standard. 1.8 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.
Keywordsspinous process plate; static test methods; fatigue test methods; pull-off test methods; plate dissociation test methods;
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top