<h3>BACKGROUND CONTEXT</h3> Motion preservation devices have become increasingly popular in the treatment of spinal pathologies that require biomechanical support following removal of the degenerated tissue. As these devices continue to be developed to treat multiple adjacent diseased spinal levels, like the use of multiple disc prostheses or placement of a disc prosthesis adjacent to a fused level, in-depth biomechanical data that supports these established surgical methods are needed. <h3>PURPOSE</h3> To assess immediate stability of four cervical disc prostheses under low endurance multidirectional cyclic loading conditions in a cadaveric cervical spine model. <h3>STUDY DESIGN/SETTING</h3> Each prosthesis was implanted in a cervical functional spinal unit (FSU) and cyclically loaded 2000 times under physiological ranges of combined flexion/extension coupled with axial rotation at a rate of 2.5deg/s. <h3>PATIENT SAMPLE</h3> There were 16 (C4-C5) and 16 (C6-C7) FSUs dissected from eight male and eight female cadaveric cervical spines with an average age of 55.9 +/- 9.7 years. Three FSUs were not usable due to poor tissue quality which reduced the sample size to 29 FSUs. <h3>OUTCOME MEASURES</h3> A one-way repeated measures ANOVA with a Student Newman-Keuls test was used to compare differences in the combined motion data. Anteroposterior endplate migration of both the upper and lower implant components was measured after 20, 250, 500, 1,000, 1,500 and 2,000 cycles. Tests were stopped if implant component migration exceeded 3mm or endplate fracture was observed, and migrations less than 0.3mm were defined as clinically stable. <h3>METHODS</h3> Four cervical disc prostheses that had a similar ball and socket type articulation mechanism but varying endplate fixation features were tested: 1. A clinically used and FDA-approved single central keel (SCK). 2. A clinically used (outside the U.S.) low profile teeth (LPT) with domed endplate shape to allow a better fit in case of concave vertebral endplate. 3. A clinically used (outside the U.S.) tripod keel (TK) and 4. Small single keel (SSK). A minimum sample size of six implants per prosthesis type were used. Three additional TK disc prostheses and two additional LPT disc prostheses were implanted. Specimens were cyclically tested 2,000 times at a rate of 2.5deg/s to an end limit of 1.5Nm in flexion or extension coupled with 1.5Nm of right and left axial rotation resulting in a total applied moment of 2.25Nm. A one-way repeated measures ANOVA with a Student Newman-Keuls test was used to compare differences in the combined motion data. Anteroposterior endplate migration of both the upper and lower implant components was measured after 20, 250, 500, 1,000, 1,500, and 2,000 cycles. Tests were stopped if implant component migration exceeded 3mm or endplate fracture was observed, and migrations less than 0.3mm were defined as clinically stable. <h3>RESULTS</h3> No statistical difference was found between the combined (flexion plus extension) sagittal plane range of motion or the combined (left plus right) axial motion. All but one of the specimen migration values were below 0.3mm. Upper prosthesis component migration ranged between 0.02mm and 0.08mm and between 0.01mm and 0.04mm for the lower components. No significant differences occurred between the upper components or the lower prosthesis components of any implant type. <h3>CONCLUSIONS</h3> Three different low profile endplate fixation designs for a cervical disc were found to provide comparable immediate holding strength to an existing FDA-approved central-based keel design. <h3>FDA DEVICE/DRUG STATUS</h3> Prodisc C (Approved for this indication), Prodisc C Vivo (Investigational/Not approved), Prodisc C Nova (Investigational/Not approved), Prodisc C SK (Investigational/Not approved).
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