Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

Aggarwal, Nitish; Chow, Robert M.

doi:10.17085/apm.20093

Cited by 6 publications

(4 citation statements)

References 13 publications

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“…Some authors have also optimized the structure of Coflex by means of topological optimization to reduce the concentration of spinous stress and reduce the incidence of complications [29,30]. The results of our study showed that the maximum spinous stresses occurred during extension and that the maximum contact forces on the spinous process occurred at the L4 spinous process in all fixation models, with the highest in the X-Stop model, which is consistent with the clinical findings of spinous fractures reported in a systematic review [31], where up to 14 spinous fractures cases were reported in the X-Stop, significantly higher than the 5 cases in the Coflex, with the difference being statistically significant. It is possible that the spine disruption load may be reduced if under repeated loading, leading to the occurrence of spine fractures.…”

Section: Discussionsupporting

confidence: 88%

Biomechanical comparison of different interspinous process devices in the treatment of lumbar spinal stenosis: a finite element analysis

Liu

Zhang

et al. 2022

BMC Musculoskelet Disord

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Background Lumbar spinal stenosis (LSS) is a common disease among elderly individuals, and surgery is an effective treatment. The development of minimally invasive surgical techniques, such as the lumbar interspinous process device (IPD), has provided patients with more surgical options. Objective To investigate the biomechanical properties of different IPDs, including BacFuse, X-Stop and Coflex, in the treatment of LSS. Methods Based on the computed tomography images of a patient with LSS, four finite element (FE) models of L3-S5 were created in this study. The FE models included a surgical model of the intact lumbar spine and surgical models of the lumbar IPDs BacFuse, X-Stop, and Coflex. After validating the models, they were simulated for four physiological motions: flexion, extension, lateral bending and axial rotation, and range of motion (ROM). Stress distribution of discs and facet joints in each segment, stress distribution of the spinous process in the operated section, and stress distribution of the internal fixation were compared and analysed. Results Compared to the model of the intact lumbar spine, the other three models showed a decrease in ROM and disc and facet joint stresses in the surgical segment during movement and an increase in ROM and disc and facet joint stresses in the adjacent segments. These effects were greater for the proximal adjacent segment with BacFuse and more pronounced for the distal adjacent segment with Coflex, while X-Stop had the greatest stress effect on the spinous process in the surgical segment. Conclusion BacFuse, Coflex and X-Stop could all be implemented to effectively reduce extension and disc and facet joint stresses, but they also increase the ROM and disc and facet joint stresses in adjacent segments, which may cause degeneration.

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Section: Discussionsupporting

confidence: 88%

Biomechanical comparison of different interspinous process devices in the treatment of lumbar spinal stenosis: a finite element analysis

Liu

Zhang

et al. 2022

BMC Musculoskelet Disord

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“…It was found that the probability of Coflex loosening is 60%. Previous research has reported Coflex loosening probability of 4.7–20.5% during long-term follow-up [ 18 – 21 ]. Our findings indicated a higher incidence of Coflex loosening and found no effect on clinical outcomes.…”

Section: Discussionmentioning

confidence: 99%

Complications and radiographic changes after implantation of interspinous process devices: average eight-year follow-up

Li,

Chen

et al. 2023

BMC Musculoskelet Disord

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Purpose This study aims to evaluate complications, clinical outcomes, and radiographic results following Coflex implantation. Methods We retrospectively studied 66 patients who had decompressive surgery combined with Coflex implantation to treat lumbar spinal stenosis. All imaging data were collected and examined for imaging changes. Clinical outcomes, included Oswestry Disability Index (ODI), back and leg visual analog scale (VAS) scores, were evaluated before surgery, six months after surgery and at the last follow-up. The number of complications occurring after five years of follow-up was counted. All reoperation cases were meticulously recorded. Results 66 patients were followed up for 5–14 years. The VAS and ODI scores were significantly improved compared with baseline. Heterotopic Ossification (HO) was detectable in 59 (89.4%). 26 (39.4%) patients had osteolysis at the contact site of Coflex with the spinous process. Coflex loosening was detected in 39 (60%) patients. Spinous process anastomosis was found in 34 (51.5%) patients. There was a statistically significant difference in the VAS score of back pain between patients with and without spinous process anastomosis. Nine cases of lumbar spinal restenosis were observed, and prosthesis fracture was observed in one case. Conclusion Our study identified various imaging changes after Coflex implantation, and majority of them did not affect clinical outcomes. The majority of patients had HO, but osteolysis and Coflex loosening were relatively rare. The VAS score for back pain of these patients was higher if they have spinous process anastomosis. After five-year follow-up, we found lumbar spinal restenosis and prosthesis fracture cases.

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“…Device manufacturers and device user facilities are required to report any device malfunction and any suspected device-related serious injury or death. The MAUDE database has been used previously to describe complications associated with multiple chronic pain devices 10–15. As such, it has become an important source of real-world information to analyze large cohorts of device-related complications.…”

mentioning

confidence: 99%

“…The MAUDE database has been used previously to describe complications associated with multiple chronic pain devices. [10][11][12][13][14][15] As such, it has become an important source of real-world information to analyze large cohorts of device-related complications. It is important to note that there are limitations to utilizing the MAUDE database as it is not intended to evaluate rates of adverse events (AEs) or to perform comparative analyses across different devices.…”

mentioning

confidence: 99%

Adverse Events Associated With 10-kHz Dorsal Column Spinal Cord Stimulation

D’Souza¹,

Olatoye²,

Butler³

et al. 2022

The Clinical Journal of Pain

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Background: High-frequency (10-kHz) spinal cord stimulation (SCS) continues to be an emerging therapy in chronic pain management. The same complications that plagued earlier SCS systems may affect newer stimulation technologies, although there is limited data on the type of complications and surgical management of these complications. Objective: The aim of this study was to systematically examine real-world complications associated with 10-kHz SCS reported on the Manufacturer and User Facility Device Experience (MAUDE) database. Materials and Methods: The MAUDE database was queried for entries reported between January 1, 2016 and December 31, 2020. Entries were classified into procedural complications, device-related complications, patient complaints, surgically managed complications, serious adverse events, and/or other complications. Primary outcomes included type and frequency of complications, and surgical management of complications. Results: A total of 1651 entries were analyzed. Most entries were categorized as procedural complications (72.6%), followed by serious adverse events (10.5%), device-related complications (10.5%), and patient complaints (9.9%). Most complications were managed surgically with explant (50.9%) rather than revision (5.0%) or incision/drainage (6.6%). Of procedural complications, the most common entries included non-neuraxial infection (52.9%), new neurological symptoms (14.7%), and dural puncture (9.5%). Of device-related complications, the most common entries included lead damage (41.6%), erosion (18.5%), and difficult insertion (11.5%). Conclusion: This retrospective 5-year analysis of complications from10-kHz SCS provides a real-world assessment of safety data unique for this stimulation modality. This analysis may help inform future clinical decisions, lead to device enhancement and optimization, and improve mitigation of risks to provide safe and efficacious use of 10-kHz SCS.

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Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

Cited by 6 publications

References 13 publications

Biomechanical comparison of different interspinous process devices in the treatment of lumbar spinal stenosis: a finite element analysis

Biomechanical comparison of different interspinous process devices in the treatment of lumbar spinal stenosis: a finite element analysis

Complications and radiographic changes after implantation of interspinous process devices: average eight-year follow-up

Adverse Events Associated With 10-kHz Dorsal Column Spinal Cord Stimulation

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