Prosthesis design and likelihood of achieving physiological range of motion after cervical disc arthroplasty: Analysis of range of motion data from 1,173 patients from 7 IDE clinical trials

The functional goals of cervical disc arthroplasty (CDA) are to restore enough range of motion (ROM) to reduce the risk of accelerated adjacent segment degeneration but limit excessive motion to maintain a biomechanically stable index segment. This motion-range is termed the “Physiological mobility range.” Clinical studies report postoperative ROM averaged over all study subjects but they do not report what proportion of reconstructed segments yield ROM in the Physiological mobility range following CDA surgery. To calculate the proportion of reconstructed segments that yield flexion-extension ROM (FE-ROM) in the Physiological mobility range (defined as 5-16 degrees) by analyzing the 24-month postoperative data reported by clinical trials of various cervical disc prostheses. Analysis of 24-month postoperative FE-ROM data from clinical trials. Data from 1,173 patients from single-level disc replacement clinical trials of 7 cervical disc prostheses. 24-month postoperative index-level FE-ROM. The FE-ROM histograms reported in Food and Drug Administration-Investigational Device Exemption (FDA-IDE) submissions and available for this analysis were used to calculate the frequencies of implanted levels with postoperative FE-ROM in the following motion-ranges: Hypomobile [0–4 degrees], Physiological [5–16 degrees], and Hypermobile [≥17 degrees]. The ROM histograms also allowed calculation of the average ROM of implanted segments in each of the 3 motion-ranges. Only 762 of 1,173 patients (implanted levels) yielded 24-month post-CDA FE-ROM in the physiological mobility range [5–16 degrees]. The proportions ranged from 60% to 79% across the 7 disc-prostheses, with an average of 65.0%±6.2%. Three-hundred and two (302) of 1,173 implanted levels yielded ROM in the 0–4-degree range. The proportions ranged from 15% to 38% with an average of 25.7%±8.9%. One-hundred and nine (109) of 1,173 implanted levels yielded ROM of ≥17 degrees with a range of 2%-21% and an average proportion of 9.3%±7.9%. The prosthesis with built-in stiffness due to its nucleus-annulus design yielded the highest proportion (103/131, 79%) of implanted segments in the physiological mobility range, compared to the cohort average of 65% (p