The Changes in Range of Motion after a Lumbar Spinal Arthroplasty with Charite (TM) in the Human Cadaveric Spine under Physiologic Compressive Follower Preload : A Comparative Study between Load Control Protocol and Hybrid Protocol

Abstract

Objective: To compare two testing protocols for evaluating range of motion (ROM) changes in the preloaded cadaveric spines implanted with a mobile core type Charite (TM) lumbar artificial disc. Methods: Using five human cadaveric lumbosacral spines (L2-S2), baseline ROMs were measured with a bending moment of 8 Nm for all motion modes (flexion/extension, lateral bending, and axial rotation) in intact spine. The ROM was tracked using a video-based motion-capturing system. After the Charite (TM) disc was implanted at the L4-L5 level, the measurement was repeated using two different methods : 1) loading up to 8 Nm with the compressive follower preload as in testing the intact spine (Load control protocol), 2) loading in displacement control until the total ROM of L2-S2 matches that when the intact spine was loaded under load control (Hybrid protocol). The comparison between the data of each protocol was performed. Results: The ROMs of the L4-L5 arthroplasty level were increased in all test modalities (p < 0.05) in bending and rotation) under both load and hybrid protocols. At the adjacent segments, the ROMs were increased in all modes except flexion under load control protocol. Under hybrid protocol, the adjacent segments demonstrated decreased ROMs in all modalities except extension at the inferior segment. Statistical significance between load and hybrid protocols was observed during bending and rotation at the operative and adjacent levels (p < 0.05). Conclusion: In hybrid protocol, the Charite (TM) disc provided a relatively better restoration of ROM, than in the load control protocol, reproducing clinical observations in terms of motion following surgery.