Abstract
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.
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References
McCulloch JA (1996) Focus issue on lumbar disc herniation: macro- and microdiscectomy. Spine 21:45S–56S
Koebbe CJ, Maroon JC, Abla A, El-Kadi H, Bost J (2002) Lumbar microdiscectomy: a historical perspective and current technical considerations. Neurosurg Focus 13:1–6
Wenger M, Mariani L, Kalbarczyk A, Gröger U (2001) Long-term outcome of 104 patients after lumbar sequestrectomy according to Williams. Neurosurgery 49:329–334
Carragee EJ, Spinnickie AO, Alamin TF, Paragioudakis S (2006) A prospective controlled study of limited versus subtotal posterior discectomy: short-term outcomes in patients with herniated lumbar intervertebral discs and large posterior annular defect. Spine 31:653–657
Brinckmann P, Grootenboer H (1991) Change of disc height, radial disc bulge, and intradiscal pressure from discectomy: an in vitro investigation on human lumbar discs. Spine 16:641–646
Thome C, Barth MB, Diepers M, Schmiedek P (2006) A prospective randomized comparison of clinical and radiological outcome after lumbar sequestrectomy versus microdiscectomy. Eur Spine J 15:S477–S478
Tibrewal SB, Pearcy MJ (1985) Lumbar intervertebral disc heights in normal subjects and patients with disc herniation. Spine 10:452–454
Yorimitsu E, Chiba K, Toyama Y, Hirabayashi K (2001) Long-term outcomes of standard discectomy for lumbar disc herniation. Spine 26:652–657
Atlas SJ, Keller RB, Wu YA, Deyo R, Singer D (2005) Long-term outcome of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Main lumbar spine study. Spine 30:927–935
Korge A, Nydegger T, Polard JL, Mayer H, Husson J (2002) A spiral implant as nucleus prosthesis in the lumbar spine. Eur Spine J 11:S149–S153
Bertagnoli R, Schönmayr R (2002) Surgical and clinical results with the PDN® prosthetic disc-nucleus device. Eur Spine J 11:S143–S148
Walkenhorst J, Lee D, Spenciner D (2004) Extrusion resistance of an injectable nucleus replacement in the human cadaver spine. Poster IMAST
Kitchel S, Capello J (2003) Injectable biomaterials for augmentation of the nucleus pulposus. Poster IMAST
Dewing CB, Provencher MT, Riffenburgh RH, Kerr S, Manos RE (2008) The outcomes of lumbar microdiscectomy in a young, active population: correlation by herniation type and level. Spine 33:33–38
Fountas KN, Kapsalaki EZ, Feltes CH, Smisson HF, Johnston KW, Vogel RL et al (2004) Correlation of the amount of disc removed in a lumbar microdiscectomy with long-term outcome. Spine 29:2521–2524
Ray CD (2002) The PDN® prosthetic disc-nucleus device. Eur Spine J 11:S137–S142
Ahrens M, Donkersloot P, Martens F, Sherman J, Le Huec JC, Tsantrizos A et al (2007) Nucleus replacement using an in situ cured, balloon contained, injectable polyurethane device: clinical results from two prospective multicenter European studies. Spine J 7:S103
Nachemson A (1962) Some mechanical properties of the lumbar intervertebral disc. Bull Hosp Joint Dis 23:130–132
Bao QB, Yuan HA (2002) New technologies in Spine: nucleus replacement. Spine 27:1245–1247
Chenite A, Chaput C, Wang D, Combes C, Buschmann MD, Hoemann CD et al (2000) Novel injectable neutral solutions of chitosan form biodegradable gels in situ. Biomaterials 21:2155–2161
Ferrari FA, Richardson C, Chambers J, Causey S, Pollock T, Cappello J et al (2002) Peptides comprising repetitive units of amino acids and DNA sequences encoding the same. US Patent 6,355,776
Hubbell JA, Wetering Pvd, Cowling DSP (2002) Novel polymer compounds. US Patent 2002/0177680
Olsen DR, Chang R, McMullin H, Hitzeman R, Chisholm G (2002) Recombinant gelatin and full-length triple helical collagen. US Patent 6,413,742
Urry DW (1991) Polynanopeptide bioelastomers having an increased elastic modulus. US Patent 5,064,430
Di Martino A, Vaccaro AR, Lee JY, Denaro V, Lim M (2005) Nucleus pulposus replacement: basic science and indications for clinical use. Spine 30:S16–S22
DeLustro F, Dasch J, Keefe J, Ellingsworth L (1990) Immune response to allogeneic and xenogeneic implants of collagen and collagen derivatives. Clin Orthop 260:263–279
Mogues T, Junzhi L, Coburn J, Kuter D (2005) IgG antibodies against bovine serum albumin in humans–their prevalence and response to exposure to bovine serum albumin. J Immunol Methods 300:1–11
Findlay GF, Hall BI, Musa BS, Oliveira MD, Fear SC (1998) A 10-year follow-up of the outcome of lumbar microdiscectomy. Spine 23:1168–1171
Pearson AM, Blood EA, Frymoyer JW, Herkowitz H, Abdu W, Woodward R et al (2008) SPORT lumbar intervertebral disk herniation and back pain—does treatment, location, or morphology matter? Spine 33:428–435
Kuisma M, Karppinen J, Niinimäki J, Kurunlahti M, Haapea M, Vanharanta H et al (2006) A 3-year follow-up of lumbar spine endplate (Modic) changes. Spine 31:1714–1718
Mitra D, Cassar-Pullicino VN, McCall IW (2004) Longitudinal study of vertebral type-1 endplate changes on MR of the lumbar spine. Eur Radiol 14:1574–1581
Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H (1994) Vertebral bone-marrow changes in degenerative lumbar disc disease: an MRI study of 74 patients with low back pain. J Bone Joint Surg Br 76B:757–764
Mochida J, Toh E, Nomura T, Nishimura K (2001) The risks and benefits of percutaneous nucleotomy for lumbar disc herniation: a 10-year longitudinal study. J Bone Joint Surg Br 83B:501–505
Gorensek M, Vilendecic M, Eustacchio S, Trummer M, Eskinja N, Ledic D et al (2007) Early clinical results with the intrinsic therapeutics Barricaid® annular repair device—comparison to a prospective control group. Proceedings of the 7th annual global symposium on motion preservation technology, Berlin
Kitano T, Zerwekh JE, Usui Y, Edwards M, Flicker P, Mooney V (1993) Biochemical changes associated with the symptomatic human intervertebral disk. Clin Orthop 293:372–377
Iatridis JC, Weidenbaum M, Setton LA, Mow VC (1996) Is the nucleus pulposus a solid or a fluid? Mechanical behaviors of the nucleus pulposus of the human intervertebral disc. Spine 21:1174–1184
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Spine Wave Inc. provided implants and support for this study. Approval for this study was obtained through the Bern Ethics Committee and SwissMedic.
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Berlemann, U., Schwarzenbach, O. An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study. Eur Spine J 18, 1706–1712 (2009). https://doi.org/10.1007/s00586-009-1136-0
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DOI: https://doi.org/10.1007/s00586-009-1136-0