Interspinous implants to treat spinal stenosis

Gala, Raj J.; Russo, Glenn S.; Whang, Peter G.

doi:10.1007/s12178-017-9413-8

Cited by 40 publications

(39 citation statements)

References 19 publications

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“…This helps to maintain a bigger central spinal and neuroforaminal canal. The concept of interspinous process devices for the treatment of LSS began in the 1950s, at which time metal plugs were inserted between the spinous processes . The therapeutic goal of the current generation of ISS devices is to produce slight lumbar flexion at the treated level(s), thus maximizing the potential space in the spinal canal, while allowing the untreated levels to move freely.…”

Section: Therapies To Consider For the Treatment Algorithmmentioning

confidence: 99%

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

Deer¹,

Grider

Pope

et al. 2018

Pain Practice

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Background Lumbar spinal stenosis (LSS) can lead to compression of neural elements and manifest as low back and leg pain. LSS has traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural spinal injections) and invasive (surgical decompression) options. Recently, several minimally invasive procedures have expanded the treatment options. Methods The Lumbar Spinal Stenosis Consensus Group convened to evaluate the peer‐reviewed literature as the basis for making minimally invasive spine treatment (MIST) recommendations. Eleven consensus points were clearly defined with evidence strength, recommendation grade, and consensus level using U.S. Preventive Services Task Force criteria. The Consensus Group also created a treatment algorithm. Literature searches yielded 9 studies (2 randomized controlled trials [RCTs]; 7 observational studies, 4 prospective and 3 retrospective) of minimally invasive spine treatments, and 1 RCT for spacers. Results The LSS treatment choice is dependent on the degree of stenosis; spinal or anatomic level; architecture of the stenosis; severity of the symptoms; failed, past, less invasive treatments; previous fusions or other open surgical approaches; and patient comorbidities. There is Level I evidence for percutaneous image‐guided lumbar decompression as superior to lumbar epidural steroid injection, and 1 RCT supported spacer use in a noninferiority study comparing 2 spacer products currently available. Conclusions MISTs should be used in a judicious and algorithmic fashion to treat LSS, based on the evidence of efficacy and safety in the peer‐reviewed literature. The MIST Consensus Group recommend that these procedures be used in a multimodal fashion as part of an evidence‐based decision algorithm.

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Section: Therapies To Consider For the Treatment Algorithmmentioning

confidence: 99%

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

Deer¹,

Grider

Pope

et al. 2018

Pain Practice

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“…The non-fusion surgery can minimize the influence on adjacent segments by preserving the motion of the lesion segments to prevent the occurrence of ASDeg. However, when faced with severe clinical situation of lumbar instability, osteoporosis and severe spinal stenosis, fusion is usually needed [5,6,13,18] . The increase of movement and stress of adjacent segments after fusion is the main cause of ASDeg, moreover, for the degenerated adjacent disc , fusion may accelerate degeneration process, even result in symptomatic degeneration [19,20] , especially for those with indications of fusion and moderate degeneration in the superior adjacent disc(Pfirrmann grade II-IV) [21] , the fusion segments should be minimized while achieving good clinical results.…”

Section: Discussionmentioning

confidence: 99%

“…[4] . Although interspinous dynamic internal fixation system, to some extent, can delay the emergence of ASDeg, fusion is often required in order to achieve fully decompression and stability for patients with severe spinal stenosis or lumbar instability [5,6] . The topping-off technique, combining lumbar fusion with the dynamic interspinous internal fixation system (Coflex), can not only provide adequate decompression to achieve good clinical efficacy but also protecting preexisting degenerated adjacent segments [7] .…”

Section: Backgroundsmentioning

confidence: 99%

Biomechanical Changes of Degenerated Adjacent Segment and Intact lumbar Spine after lumbosacral Topping-off surgery: A Three-dimensional Finite Element Analysis

Cao

Liu

Mei

et al. 2020

Preprint

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Background : Previous studies have revealed positive effect of Topping-off technique on upper adjacent segment after fusion surgery, while for the cases with fusion surgery on L5-S1 segment, owning maximal range of motion, and preexisting degenerated upper adjacent disc, it is necessary to clarify the superiority of Topping-ff technique and the effect exerted on the lumbar spine. Methods: A young healthy male volunteer was selected for thin-slice CT scanning. Then the image information was imported into the computer to establish the whole lumbar spine model as the health model. The medium degeneration model of intervertebral disc was established by changing the material properties of L4-S1 disc on the basis of the health model, and the fusion model and Topping-off model were respectively established on the basis of the degenerated model. The variation trend of ROM of L2-L5 and the stress changes of L4-L5 intervertebral disc, nucleus pulposus and facet joints were calculated respectively. Results: The L4-L5 ROM of fusion model increased significantly but the ROM of L2-L3 and L3-L4 segments did not change significantly. Compared with the degenerated model, L4-L5 activity of the Topping-off model decreased, and ROM of the L2-L3 and L3-L4 increased to some extent in the flexion and extension positions. the stress on the disc, nucleus pulposus and facet joint of the fusion model L4-L5 increased in four positions of flexion, extension, rotation and bending compared with the degenerated model, while the fiber stress on the Topping-off model decreased significantly in all four positions. Conclusion: Topping-off technology can decrease the stress and ROM of the adjacent upper degenerated segment, and increase the ROM of other upper segments, thereby protecting the degenerated upper adjacent segments and compensating the lumbar spine mobility.

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“…In the 1990s, Professor Jacques Samani invented the U-shaped interspinous process xation device, and achieved good results in clinical applications [7] . The FDA approved indications for Co ex is one-or twolevel lumbar stenosis from L1 to L5 producing at least moderate impairment in skeletally mature patients [8] . The FDA states that patients receiving this treatment should be those who experienced relief of symptoms with exion of the lumbar spine and had undergone non-surgical treatment for more than 6 months.…”

Section: Discussionmentioning

confidence: 99%

Coflex Interspinous Process Dynamic Stabilization for Lumbar Spinal Stenosis: Long-term Follow-up

Wei

Zhu

et al. 2020

Preprint

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[Objective]To evaluate the long-term efficacy of Coflex interspinous process dynamic stabilization device in the treatment of lumbar spinal stenosis.[Methods]The clinical and imaging data of 73 patients undergoing Coflex interspinous process dynamic stabilization surgery from July 2008 to June 2012 were retrospectively analyzed. Clinical data include: visual analogue scale of pain (VAS), Owestry disability index(ODI) and Japanese Orthopedic Association Scores(JOA) of preoperation, 6 months after surgery, and last follow-up; complications; reoperation rates and incidence of adjacent segment degeneration(ASD). Imaging data including: lumbar range of motion(ROM), intervertebral space height(ISH) and intervertebral foramen height (IFH) of operative and adjacent segment at preoperative, 6 months after operation and the last follow-up.[Results]56 patients were followed up. The follow-up time was 107.6 ± 13.3 months, the operation time was 10.0 ± 3.1 minutes, the intraoperative blood loss was 153.9 ± 80.6 ml, and the hospitalization time was 10.2 ± 3.2 days. The VAS, ODI and JOA scores improved significantly after surgery. At 6 months after surgery and the last follow-up, ROM was significantly lower than that before surgery with statistical significance (P < 0.001). ROM was slightly increased at the last follow-up compared with that 6 months after operation, but the difference was not statistically significant (P > 0.05). The ROM of adjacent segments increased at 6 months and at the last follow-up compared with that before surgery, but the difference was not statistically significant (P > 0.05). At 6 months after surgery, ISH and IFH of implanted segment was significantly higher than that before surgery, and the difference was statistically significant (P < 0.05). At the last follow-up, there was a decrease in ISH and IFH, with no statistical difference compared with that before the operation. During the follow-up period, a total of 11 patients (19.6%) experienced complications and 6 patients (10.7%) underwent secondary surgery.[Conclusion]Coflex interspinous process dynamic stabilization is effective in the treatment of lumbar spinal stenosis in the long term. The surgical segment retains a small range of motion. The incidence of complications and reoperation is low. However, the ISH and IFH of implanted segment can only be maintained for a short period of time.

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Interspinous implants to treat spinal stenosis

Cited by 40 publications

References 19 publications

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

Biomechanical Changes of Degenerated Adjacent Segment and Intact lumbar Spine after lumbosacral Topping-off surgery: A Three-dimensional Finite Element Analysis

Coflex Interspinous Process Dynamic Stabilization for Lumbar Spinal Stenosis: Long-term Follow-up

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