The Spine Journal
In Press, Corrected Proof, Available online 11 December 2009

Determination of the in vivo posterior loading environment of the Coflex interlaminar-interspinous implant

Frank T. Trautwein Dipl-Ing(FH)a, Gary L. Lowery MD, PhDb, Nicholas D. Wharton MSc, John A. Hipp PhDc and Robert J. Chomiak MSa. a Paradigm Spine, GmbH, Eisenbahnstrasse 84, D-78573 Wurmlingen, Germany. b Paradigm Spine, LLC, 505 Park Ave., 14th Floor, New York, NY 10022, USA. c Medical Metrics, Inc., Houston, TX 77027, USA. Copyright © 2009 Published by Elsevier Inc.

Background Context

The in vivo loading environment of load-bearing implants is generally largely unknown. Loads are typically approximated from cadaver tests or biomechanical calculations for the preclinical assessment of a device's safety and efficacy.

Purpose

To determine the actual in vivo loading environment of an elastic interlaminar-interspinous implant (Coflex).

Study Design

A retrospective radiographic study to noninvasively measure the in vivo implant loads of 176 patients.

Methods

For this study, neutral, flexion, and extension radiographs were quantitatively analyzed using validated image analysis technology. The angle between the Coflex arms was measured for each radiograph and statistically evaluated. Separately, the Coflex implant was characterized using mechanical test data and finite element analysis, which resulted in a load-deformation formula that describes the implant load as a function of its size and elastic deformation. Using the formula and the elastic implant deformation data obtained from the radiographic analysis, the exact implant load was calculated for each patient and each posture. For statistical analysis, the patients were grouped by indication and procedure, which resulted in 12 different groups. The determined loads were compared with the strength of the posterior lumbar spinal elements obtained from the literature and with the static and dynamic mechanical limits of the Coflex interlaminar-interspinous implant.

Results

The force data were independent of implant size, diagnosis (with one exception), number of levels of the decompression procedure, number of levels of implantations (one or two), and follow-up time. The median compressive force acting on the Coflex implant was found to be 45.8 N. The maximum load change between flexion and extension was 140 N; the maximum overall load exceeded 239 N in extension.

Conclusions

The average loads exerted by the Coflex implant on the spinous process and lamina are 11.3% and 7.0% of their respective static failure load. The implant fatigue strength is significantly higher than the measured median force, which explains the extremely rare observation of a Coflex fatigue failure.

Coflex; Interlaminar-interspinous; In vivo load; Strength; FEA