Minimum 2-Year Follow-Up Result of Degenerative Spinal Stenosis Treated with Interspinous U (Coflex<sup>TM</sup>

Park, Seong-Cheol; Yoon, Soo Han; Hong, Yong Pyo; Kim, Ki-Jeong; Chung, Sang Ki; Kim, Hyun Jib

doi:10.3340/jkns.2009.46.4.292

Cited by 48 publications

(45 citation statements)

References 21 publications

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“…Some possible complications from ISS implantation are spinous process fracture, implant dislocation, and re operation due to persistent pain (ineffective implant); how ever, these incidences seem to be sporadic and have been related specifically to dynamic ISSs, 15,16 which are not promoted as fusion devices. The selection of an interspinous fusion spacer as a suitable option needs to be carefully evaluated since the incidence of complications may be associated with the device's indication.…”

Section: Clinical Complications Of Interspinous Spacersmentioning

confidence: 99%

Biomechanical analysis of an interspinous fusion device as a stand-alone and as supplemental fixation to posterior expandable interbody cages in the lumbar spine

Gonzalez-Blohm

Doulgeris

Aghayev

et al. 2014

SPI

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Object In this paper the authors evaluate through in vitro biomechanical testing the performance of an interspinous fusion device as a stand-alone device, after lumbar decompression surgery, and as supplemental fixation to expandable cages in a posterior lumbar interbody fusion (PLIF) construct. Methods Nine L3–4 human cadaveric spines were biomechanically tested under the following conditions: 1) intact/control; 2) L3–4 left hemilaminotomy with partial discectomy (injury); 3) interspinous spacer (ISS); 4) bilateral pedicle screw system (BPSS); 5) bilateral hemilaminectomy, discectomy, and expandable posterior interbody cages with ISS (PLIF-ISS); and 6) PLIF-BPSS. Each test consisted of 100 N of axial preload with ± 7.5 Nm of torque in flexion-extension, right/left lateral bending, and right/left axial rotation. Significant changes in range of motion (ROM), neutral zone stiffness (NZS), elastic zone stiffness (EZS), and energy loss (EL) were explored among conditions using nonparametric Friedman test and Wilcoxon signed-rank comparisons (p ≤ 0.05). Results The injury increased ROM in flexion (p = 0.01), left bending (p = 0.03), and right/left rotation (p < 0.01) and also decreased NZS in flexion (p = 0.01) and extension (p < 0.01). Both the ISS and BPSS reduced flexion-extension ROM and increased flexion-extension stiffness (NZS and EZS) with respect to the injury and intact conditions (p < 0.05), but the ISS condition provided greater resistance than BPSS in extension for ROM, NZS, and EZS (p < 0.01). The BPSS increased the rigidity (ROM, NZS, and EZS) of the intact model in lateral bending and axial rotation (p ≤ 0.01), except in EZS for left rotation (p = 0.23, Friedman test). The incorporation of posterior cages marginally increased (p = 0.05) the EZS of the BPSS construct in flexion but these interbody devices provided significant stability to the ISS construct in lateral bending and axial rotation for ROM (p = 0.02), in lateral bending for NZS (p = 0.02), and in flexion/axial rotation for EZS (p ≤ 0.03); however, both PLIF constructs demonstrated equivalent ROM and stiffness (p ≥ 0.16), except in lateral bending where the PLIF-BPSS was more stable (p = 0.02). In terms of EL, the injury increased EL in flexion-extension (p = 0.02), the ISS increased EL for lateral bending and axial rotation (p ≤ 0.03), and the BPSS decreased EL in lateral bending (p = 0.02), with respect to the intact condition. The PLIF-ISS decreased lateral bending EL with respect to the ISS condition (p = 0.02), but not enough to be smaller or, at least, equivalent, to that of the PLIF-BPSS construct (p = 0.02). Conclusions The ISS may be a suitable device to provide immediate flexion-extension balance after a unilateral laminotomy, but the BPSS provides greater immediate stability in lateral bending and axial rotation motions. Both PLIF constructs performed equivalently in flexion-extension and axial rotation, but the PLIF-BPSS construct is more resistant to lateral bending motions. Further biomechanical and clinical evidence is required to strongly support the recommendation of a stand-alone interspinous fusion device or as supplemental fixation to expandable posterior interbody cages.

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Section: Clinical Complications Of Interspinous Spacersmentioning

confidence: 99%

Biomechanical analysis of an interspinous fusion device as a stand-alone and as supplemental fixation to posterior expandable interbody cages in the lumbar spine

Gonzalez-Blohm

Doulgeris

Aghayev

et al. 2014

SPI

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“…Since then, the device has been used in various degenerative spinal conditions [21][22][23][24][36][37][38]. Although it was initially developed as a motion-preserving alternative used to treat various lumbar degenerative disorders, long-term studies from Europe suggested that the subset of patients with spinal stenosis and Grade I spondylolisthesis experienced the most significant improvement.…”

Section: Discussionmentioning

confidence: 99%

Is the Interspinous Device (Coflex) Outdated in the Treatment of Lumbar Spinal Stenosis? A Seven-Year Follow-up

Yin¹,

Zheng²,

Gu³

et al. 2018

Spine Research

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Background: Coflex, a kind of dynamic interspinous spacer, has been widely used for the treatment of lumbar spinal stenosis in the past a few years. However, controversy remains as to whether dynamic interspinous spacer use is superior to traditional decompression and fusion surgery. High complication, reoperation rate, and costs with poor outcomes were also mentioned in the literature. The aim of the present study is to evaluate whether Coflex implantation following spinal decompression provided better clinical outcomes compared with traditional decompression and fusion for symptomatic lumbar spinal stenosis through midterm follow-up.

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“…However, bone erosion around the Coflex, especially around spikes, was found in 57 % of all patients treated with the interspinous process device [9]; therefore, its use in the elderly, especially in severe osteoporotic patients, should be carefully considered.…”

Section: Coflex Device-related Complicationsmentioning

confidence: 99%

“…Besides that, some scholars [9,[25][26][27] recommend application of Coflex to elderly patients for its shorter operation time and minimally invasive merits. However, bone erosion around the Coflex, especially around spikes, was found in 57 % of all patients treated with the interspinous process device [9]; therefore, its use in the elderly, especially in severe osteoporotic patients, should be carefully considered.…”

Section: Coflex Device-related Complicationsmentioning

confidence: 99%

“…Recently, the encouraging results of Coflex have been widely reported. However, the complications were rarely reported [8,9]. Although some case reports have shown a few complications such as prosthesis loosening, prosthesis breakage and spinous process fracture [7,10], none of them has systematically analysed its incidence and therapeutic measures.…”

Section: Introductionmentioning

confidence: 99%

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Complications in degenerative lumbar disease treated with a dynamic interspinous spacer (Coflex)

Tian

et al. 2013

International Orthopaedics (SICOT)

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Purpose The purpose of this study was to quantify the intraand postoperative complications of an interspinous process device (Coflex) in managing degenerative lumbar diseases and to investigate corresponding therapeutic strategies. Methods Between January 2008 and December 2012, we retrospectively analysed a total of 131 patients who underwent decompressive surgery along with the Coflex system for the treatment of degenerative lumbar diseases. The related complications were reported, and appropriate measures were taken. Clinical outcomes and radiological data were collected and analysed, and clinical outcomes were evaluated with pairedsamples T test. Results Related complications occurred in 11 patients. Among them, six cases were found with surgical technique-related complications, including device-related complications in three cases: spinal process fracture (n=1), Coflex loosening (n=1), fixedwing breakage (n=1), dura mater tear in two cases and superficial wound infection in one case. All of them received corresponding conservative treatment and obtained a good result. The other five cases had non-device-related complications and required additional spinal surgery. The conservative therapy group had apparent improvement of VAS score and ODI, and remained well to final follow-up (P<0.05). The second operation group also improved postoperatively (each P<0.05). Conclusion The Coflex dynamic interspinous process device shows a low complication and re-operation rate. Standard operation and strict follow-up observation can effectively avoid surgical technique-related complications. The key points to ensure surgical effect and to reduce non-devicerelated complications are mastering surgical indications and thorough intra-operative decompression.

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Minimum 2-Year Follow-Up Result of Degenerative Spinal Stenosis Treated with Interspinous U (Coflex^TM

Cited by 48 publications

References 21 publications

Biomechanical analysis of an interspinous fusion device as a stand-alone and as supplemental fixation to posterior expandable interbody cages in the lumbar spine

Biomechanical analysis of an interspinous fusion device as a stand-alone and as supplemental fixation to posterior expandable interbody cages in the lumbar spine

Is the Interspinous Device (Coflex) Outdated in the Treatment of Lumbar Spinal Stenosis? A Seven-Year Follow-up

Complications in degenerative lumbar disease treated with a dynamic interspinous spacer (Coflex)

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Minimum 2-Year Follow-Up Result of Degenerative Spinal Stenosis Treated with Interspinous U (CoflexTM

Cited by 48 publications

References 21 publications

Biomechanical analysis of an interspinous fusion device as a stand-alone and as supplemental fixation to posterior expandable interbody cages in the lumbar spine

Biomechanical analysis of an interspinous fusion device as a stand-alone and as supplemental fixation to posterior expandable interbody cages in the lumbar spine

Is the Interspinous Device (Coflex) Outdated in the Treatment of Lumbar Spinal Stenosis? A Seven-Year Follow-up

Complications in degenerative lumbar disease treated with a dynamic interspinous spacer (Coflex)

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Minimum 2-Year Follow-Up Result of Degenerative Spinal Stenosis Treated with Interspinous U (Coflex^TM