Tag: PCM

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Longitudinal assessment of segmental motion of the cervical spine following total disc arthroplasty: a comparative analysis of devices

J Neurosurg Spine 37:556–562, 2022

Total disc arthroplasty (TDA) has been shown to be an effective and safe treatment for cervical degenerative disc disease at short- and midterm follow-up. However, there remains a paucity of literature reporting the differences between individual prosthesis designs with regard to device performance. In this study, the authors evaluated the longterm maintenance of segmental range of motion (ROM) at the operative cervical level across a diverse range of TDA devices.

METHODS In this study, the authors retrospectively evaluated all consecutive patients who underwent 1- or 2-level cervical TDA between 2005 and 2020 at a single institution. Patients with a minimum of 6 months of follow-up and lateral flexion/extension radiographs preoperatively, 2 months postoperatively, and at final follow-up were included. Radiographic measurements included static segmental lordosis, segmental range of motion (ROM) on flexion/extension, global cervical (C2–7) ROM on flexion/extension, and disc space height. The paired t-test was used to evaluate improvement in radiographic parameters. Subanalysis between devices was performed using one-way ANCOVA. Significance was determined at p < 0.05.

RESULTS A total of 85 patients (100 discs) were included, with a mean patient age of 46.01 ± 8.82 years and followup of 43.56 ± 39.36 months. Implantations included 22 (22.00%) M6-C, 51 (51.00%) Mobi-C, 14 (14.00%) PCM, and 13 (13.00%) ProDisc-C devices. There were no differences in baseline radiographic parameters between groups. At 2 months postoperatively, PCM provided significantly less segmental lordosis (p = 0.037) and segmental ROM (p = 0.039). At final follow-up, segmental ROM with both the PCM and ProDisc-C devices was significantly less than that with the M6-C and Mobi-C devices (p = 0.015). From preoperatively to 2 months postoperatively, PCM implantation led to a significant loss of lordosis (p < 0.001) and segmental ROM (p = 0.005) relative to the other devices. Moreover, a significantly greater decline in segmental ROM from 2 months postoperatively to final follow-up was seen with ProDiscC, while segmental ROM increased significantly over time with Mobi-C (p = 0.049).

CONCLUSIONS Analysis by TDA device brand demonstrated that motion preservation differs depending on disc design. Certain devices, including M6-C and Mobi-C, improve ROM on flexion/extension from preoperatively to postoperatively and continue to increase slightly at final follow-up. On the other hand, devices such as PCM and ProDisc-C contributed to greater segmental stiffness, with a gradual decline in ROM seen with ProDisc-C. Further studies are needed to understand how much segmental ROM is ideal after TDA for preservation of physiological cervical kinematics.

 

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Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion”

PCM vs ACDF

Spine 2015;40:674–683

Study Design. Prospective, multicenter, randomized clinical trial.

Objective. To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single- level degenerative spondylosis between C3–C4 and C7–T1 with or without prior cervical fusion.

Summary of Background Data. The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.

Methods. Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.

Results. At 5 years postoperative, all patient-reported outcomes— neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)—were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P = 0.001), neck pain (P = 0.002), general health (Pphysical component summary= 0.014; P mental component summary= 0.004), and patient satisfaction (P = 0.005).
PCM patients trended toward fewer 2- to 7-year device-related
serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P = 0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.

Conclusion. The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.
Level of Evidence: 1

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