Does an interspinous device (Coflex™) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients

Richter, A.; Schütz, Christian; Hauck, Michael; Halm, H.

doi:10.1007/s00586-009-1229-9

Cited by 80 publications

(59 citation statements)

References 17 publications

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“…While the research group was planning to perform a randomized controlled trial (RCT), such a prospective comparative study of this implant is not available in Pubmed. After the introduction of this implant by Senegas, the development of other IPDs followed, such as Minns, X-stop and Coflex [13][14][15][16]. Cadaveric studies did not show any biomechanical difference between the various IPDs, and they were therefore considered as interchangeable, although differences in clinical effectiveness were not investigated [15].…”

Section: Interspinous Process Devices Versus Microdecompressionmentioning

confidence: 99%

Minimally invasive surgery for lumbar spinal stenosis

Moojen

Gaag

2016

Eur J Orthop Surg Traumatol

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Recent trends in spine surgery, such as endoscopic and other ''micro'' techniques, promise less invasive procedures with better outcomes compared to conventional open techniques for decompressing nerves. Minimally invasive surgery (MIS), highly promoted by commercial parties for instrumented cases in particular, is popular with patients and physicians [1]. Widespread adoption of these techniques should always be preceded by careful evaluation to ensure safety and determine added value of such so-called surgical innovation [2,3]. Actual and controversial topics concerning MIS for lumbar spinal stenosis (LSS) were recently addressed in high-quality studies: open laminectomy versus microdecompression by Nerland et al. and decompression versus interspinous process implant by our group [4,5]. In some way, the opposite of MIS was addressed in a recent landmark study by Försth et al.; does decompression versus decompression plus instrumented fusion for LSS yield better outcomes [6]? The three studies address very relevant issues of the neurosurgical daily practice and will be discussed hereafter. The authors analyze data from a large, well-maintained and comprehensive national registry in Norway (the Norwegian Registry for Spine Surgery, NORspine). Thirty six out of 40 centers performing lumbar spine surgery in Norway record data prospectively in NORspine, making it a one of the unique national resource for spine research. Nerland and colleagues identified 885 eligible patients (out of 2745 screened) of whom 81 % completed the 1-year follow-up. Open laminectomy versus microdecompressionOpen laminectomy and microdecompression were associated with similar and statistically equivalent improvements in Oswestry disability scores and quality of life (EuroQol EQ-5D) at 1-year follow-up. Furthermore, the techniques did not differ in older people and obese patients in predefined subgroup analyses. The number of patients with complications was higher in the open laminectomy group (15.0 vs. 9.8 %, P = 0.018), but this difference did not hold after propensity matching (P = 0.23). Patients in the microdecompression group had shorter hospital stays, both for single-level decompression (difference 1.5 days, 95 % confidence interval 1.7-2.6, P \ 0.001) and two-level decompression (0.8 days, 1.0-2.2, P = 0.003).The authors concluded that microdecompression is the treatment of choice for patients with stenosis of the lumbar spine for the technique shows good clinical results, equal to open laminectomy at 1-year follow-up. Theoretically,

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Section: Interspinous Process Devices Versus Microdecompressionmentioning

confidence: 99%

Minimally invasive surgery for lumbar spinal stenosis

Moojen

Gaag

2016

Eur J Orthop Surg Traumatol

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“…There were no late neurological complications related to the device and no cases of Coflex penetration inside the canal or infection. Richter et al reported 3.3 % hardware related complications (spinal process fracture and prosthesis loosening) in 2010 [7]. An international multicenter retrospective study [23] that included 209 patients who underwent Coflex fixation surgery reported a 3.4 % device-related complication rate, most of which were fixed-wing breakage and prosthesis loosening.…”

Section: Coflex Device-related Complicationsmentioning

confidence: 99%

“…Furthermore, there is some evidence that fusion may increase the biomechanical stresses imposed on the adjacent segments leading to transitional diseases [1][2][3], and may be related to other problems such as serious trauma, transfusion requirement, higher morbidity and mortality for elderly patients as well as pseudarthrosis and fusion mass fracture [4,5]. In order to overcome these deficiencies associated with fusion surgery, the interspinous process device-Coflex system (Paradigm Spine Inc.®, Germany) was developed as a possible alternative to spinal decompression with a posterolateral fusion and instrumentation for the treatment of symptomatic degenerative lumbar disease including mild segmental instability, degenerative disc disease, and lumbar spinal stenosis [6,7]. Recently, the encouraging results of Coflex have been widely reported.…”

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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“…Basing upon strong research and clinical evidences, the X-STOP device has been recognized as having a role in the surgical treatment of lumbar spinal stenosis causing Neurogenic Intermittent Claudication (NIC), particularly if compared with non-operative therapy and decompressive surgery [3]. The Coflex U-shaped titanium implant has been used in same clinical scenarios [4] and in its latest version it is used as an adjunct to interbody fusion.…”

Section: Introductionmentioning

confidence: 99%

The BACJACTM Interspinous Device in the Treatment of Lumbar Spine Degenerative Disorders: A Prospective Study and 2-Year Follow-Up Results

Irace¹

2013

J Spine

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Does an interspinous device (Coflex™) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients

Abstract: A number of interspinous process devices have recently been introduced to the lumbar spinal market as an alternative to conventional surgical procedures in the treatment of symptomatic lumbar stenosis.

Cited by 80 publications

References 17 publications

Minimally invasive surgery for lumbar spinal stenosis

Minimally invasive surgery for lumbar spinal stenosis

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

The BACJACTM Interspinous Device in the Treatment of Lumbar Spine Degenerative Disorders: A Prospective Study and 2-Year Follow-Up Results

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