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Old 11-23-2011, 01:43 AM
ADR seeker ADR seeker is offline
Join Date: Apr 2011
Posts: 120
Default Another Great Implant Made in the USA BUT Americans Can't Have It!

This is an out patient minimally disruptive minimally invasive procedure that appears to be far superior to conventional surgery so I guess we won't be seeing this in the US anytime soon.


Literature indicates that loss of disc tissue from herniation and/or surgery can accelerate degeneration of the disc. The associated loss of disc height may correspond with recurrent back and/or leg pain. A novel hydrogel has been developed to replace lost nucleus pulposus and potentially restore normal disc biomechanics following herniation and surgery. A single-center, non-randomized, prospective feasibility study was undertaken to investigate the use of NuCore® Injectable Nucleus hydrogel (Spine Wave, Inc., Shelton, CT, USA) as a replacement for nuclear tissue lost to herniation and microdiscectomy. Fourteen patients were enrolled at the authors’ hospital as the initial site in a worldwide multicenter pilot study. Subjects who were entered into the study suffered from radicular pain due to single-level herniated nucleus pulposus and were non-respondent to conservative therapy. Following a standard microdiscectomy procedure, the hydrogel material was injected into the nuclear void to replace what tissue had been lost to the herniation and surgery. Leg and back pain, function and disability scores were monitored pre- and post-operatively through 2 years. Neurologic and physical evaluations, blood and serum analyses, and radiographic evaluations of disc height and implant stability were also performed. Results showed significant improvement for leg and back pain, as well as function scores. No complications or device related adverse events were observed. MR controls confirmed stable position of the implants with no reherniations. Radiographic measurements indicated better maintenance of disc height compared to literature data on microdiscectomy alone. The NuCore® material appears to protect the disc from early collapse following microdiscectomy; and therefore, may have the potential to slow the degenerative cascade of the spinal segment over time.
Keywords: Nucleus replacement, Herniation, Hydrogel, Microdiscectomy, NuCore®


Lumbar disc herniation is the most common cause of radicular leg pain in the adult working population. Although the majority of cases will improve with conservative care, surgical intervention is indicated in a significant subgroup of patients. This includes cases with severe neurological compromise, i.e., cauda equina syndrome and progressive motor deficit, as well as the larger group of cases which have failed a minimum of 6 weeks of conservative therapy [1]. If surgical intervention is needed, microdiscectomy and/or sequestrectomy under microscopical vision are recommended treatment options [2, 3].
Unsuccessful surgical results may be associated with two problems: reherniation and disc space narrowing. Reherniation of the operated disc with recurrence of radiculopathy may occur in as many as 27% of cases, particularly when a large posterior annular defect is present [4]. More aggressive removal of disc tissue might reduce the reherniation rate, but also lead to further destabilization of the segment resulting in progressive low back pain. Disc height loss and its associated increase in radial disc bulge occur in proportion to the amount of tissue lost from the disc structure [5]. Patients with lumbar disc herniations show reduced disc height pre-operatively compared to normal, with progressive narrowing over time [6, 7]. Young patients under 35 years of age and cases with advanced disc degeneration before surgery are particularly likely to suffer from accelerated disc deterioration and narrowing over time, resulting not only in discogenic low back pain, but also in spondylotic changes of the facet joints [8]. The reoperation rate after 10 years has been reported to be 25% with a median time to reoperation of 24 months [9]. Therefore, initial surgical treatment of the disc should attempt to preserve as much height and function as possible without increasing the risk for reherniation.
Several attempts have been made to design an efficient implant to replace herniated or surgically removed nucleus tissue in order to restore normal loads and biomechanics at the diseased level. Pre-formed intervertebral spacers have been tested clinically with mixed results, the main problem being migration of the implant and inflammatory reaction of the adjacent endplates [10, 11]. Recently, additional attention has been focused on injectable materials. The flowable nature of these materials allows a void of any size and shape to be filled. Thus, the nucleotomy can be as minimal or aggressive as necessary, and is not dictated by the geometry of the implant.
The present study investigates the safety and performance of the use of a novel injectable protein hydrogel as a nuclear replacement in microdiscectomy cases.


The results of this pilot study indicate that NuCore® Injectable Nucleus can be applied safely into lumbar discs following microdiscectomy. No complications or adverse events related to the material occurred. The material did not migrate from the disc and no extrusion was observed. Additionally, no reherniations were seen. Radiographic data suggest a better maintenance of disc height after 2 years compared to microdiscectomy alone. NuCore® hydrogel seems to protect the disc from early collapse following microdiscectomy and therefore could carry the potential of slowing the degenerative cascade of the spinal segment over time. If so, this treatment may also lead to reduced treatment costs in the long term for these relatively young patients. In light of the results of this study, the authors believe this material merits further investigation of its safety and efficacy in expanded control studies.

Read more here: An injectable nucleus replacement as an adjunct to microdiscectomy: 2*year follow-up in a pilot clinical study
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