Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial

Marek Holy, Anna MacDowall, Freyr Gauti Sigmundsson, Claes Olerud, Marek Holy, Anna MacDowall, Freyr Gauti Sigmundsson, Claes Olerud

Abstract

Background: Cervical radiculopathy is the most common disease in the cervical spine, affecting patients around 50-55 year of age. An operative treatment is common clinical praxis when non-operative treatment fails. The controversy is in the choice of operative treatment, conducting either anterior cervical decompression and fusion or posterior foraminotomy. The study objective is to evaluate short- and long-term outcome of anterior cervical decompression and fusion (ACDF) and posterior foraminotomy (PF) METHODS: A multicenter prospective randomized controlled trial with 1:1 randomization, ACDF vs. PF including 110 patients. The primary aim is to evaluate if PF is non-inferior to ACDF using a non-inferiority design with ACDF as "active control." The neck disability index (NDI) is the primary outcome measure, and duration of follow-up is 2 years.

Discussion: Due to absence of high level of evidence, the authors believe that a RCT will improve the evidence for using the different surgical treatments for cervical radiculopathy and strengthen current surgical treatment recommendation.

Trial registration: ClinicalTrials.gov NCT04177849. Registered on November 26, 2019.

Keywords: Anterior cervical decompression; Anterior cervical discectomy; Posterior foraminotomy; Randomized control trial.

Conflict of interest statement

The investigators have no competing interests, financial or non-financial.

© 2021. The Author(s).

References

    1. Goldstein B. Anatomic issues related to cervical and lumbosacral radiculopathy. Phys Med Rehabil Clin N Am. 2002;13(3):423–437. doi: 10.1016/S1047-9651(02)00017-7.
    1. Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994;117(Pt 2):325–335. doi: 10.1093/brain/117.2.325.
    1. Panych LP, Madore B. The physics of MRI safety. J Magn Reson Imaging. 2018;47(1):28–43. doi: 10.1002/jmri.25761.
    1. Albert TJ, Murrell SE. Surgical management of cervical radiculopathy. J Am Acad Orthop Surg. 1999;7(6):368–376. doi: 10.5435/00124635-199911000-00003.
    1. Hershman SH, Kunkle WA, Kelly MP, Buchowski JM, Ray WZ, Bumpass DB, et al. Esophageal perforation following anterior cervical spine surgery: case report and review of the literature. Global Spine J. 2017;7(1 Suppl):28S-36S, 10.1177/2192568216687535.Hershman SH, Kunkle WA, Kelly MP, Buchowski JM, Ray WZ, Bumpass DBet al. Esophageal perforation following anterior cervical spine surgery: case report and review of the literature. Global Spine J. 2017;7(1 Suppl):28S-36S, DOI: 10.1177/2192568216687535.
    1. Ghobrial GM, Harrop JS, Sasso RC, Tannoury CA, Tannoury T, Smith ZA, et al. Anterior cervical infection: presentation and incidence of an uncommon postoperative complication. Global Spine J. 2017;7(1 Suppl):12S–6S. 10.1177/2192568216687535.
    1. Gokaslan ZL, Bydon M, De la Garza-Ramos R, Smith ZA, Hsu WK, Qureshi SA, et al. Recurrent laryngeal nerve palsy after cervical spine surgery: a multicenter AOSpine clinical research network study. Global Spine J. 2017;7(1 Suppl):53S–57S. doi: 10.1177/2192568216687547.
    1. Tempel ZJ, Smith JS, Shaffrey C, Arnold PM, Fehlings MG, Mroz TE, Riew KD, Kanter AS. A multicenter review of superior laryngeal nerve injury following anterior cervical spine surgery. Global Spine J. 2017;7(1 Suppl):7S–11S. doi: 10.1177/2192568216687296.
    1. Ames CP, Clark AJ, Kanter AS, Arnold PM, Fehlings MG, Mroz TE, et al. Hypoglossal nerve palsy after cervical spine surgery. Global Spine J. 2017;7(1 Suppl):37S–9S. 10.1177/2192568216687307.
    1. Hsu WK, Kannan A, Mai HT, Fehlings MG, Smith ZA, Traynelis VC, et al. Epidemiology and outcomes of vertebral artery injury in 16 582 cervical spine surgery patients: an AOSpine North America multicenter study. Global Spine J. 2017;7(1 Suppl):21S–7S. 10.1177/2192568216686753.
    1. O'Neill KR, Fehlings MG, Mroz TE, Smith ZA, Hsu WK, Kanter AS, et al. A multicenter study of the presentation, treatment, and outcomes of cervical dural tears. Global Spine J. 2017;7(1 Suppl):58S–63S. doi: 10.1177/2192568216688186.
    1. Daniels AH, Hart RA, Hilibrand AS, Fish DE, Wang JC, Lord EL, et al. Iatrogenic spinal cord injury resulting from cervical spine surgery. Global Spine J. 2017;7(1 Suppl):84S–90S. 10.1177/2192568216688188.
    1. Traynelis VC, Malone HR, Smith ZA, Hsu WK, Kanter AS, Qureshi SA, et al. Rare complications of cervical spine surgery: Horner’s syndrome. Global Spine J. 2017;7(1 Suppl):103S–8S. 10.1177/2192568216688184.
    1. Than KD, Mummaneni PV, Smith ZA, Hsu WK, Arnold PM, Fehlings MG, et al. Brachial plexopathy after cervical spine surgery. Global Spine J. 2017;7(1 Suppl):17S–20S. 10.1177/2192568216687297.
    1. Thompson SE, Smith ZA, Hsu WK, Nassr A, Mroz TE, Fish DE, et al. C5 palsy after cervical spine surgery: a multicenter retrospective review of 59 cases. Global Spine J. 2017;7(1 Suppl):64S–70S. 10.1177/2192568216688189.
    1. Derakhshan A, Lubelski D, Steinmetz MP, Corriveau M, Lee S, Pace JR, Smith GA, Gokaslan Z, Bydon M, Arnold PM, Fehlings MG, Riew KD, Mroz TE. Thoracic duct injury following cervical spine surgery: a multicenter retrospective review. Global Spine J. 2017;7(1 Suppl):115S–119S. doi: 10.1177/2192568216688194.
    1. Skeppholm M, Olerud C. Comparison of dysphagia between cervical artificial disc replacement and fusion: data from a randomized controlled study with two years of follow-up. Spine (Phila Pa 1976) 2013;38(24):E1507–E1510. doi: 10.1097/BRS.0b013e3182a516ef.
    1. Anderson PA, Andersson GBJ, Arnold PM. al. e. Terminology. Spine. 2012;37(22S):8–9. doi: 10.1097/BRS.0b013e31826d62ed.
    1. Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J. 2004;4(6 Suppl):190S–194S. doi: 10.1016/j.spinee.2004.07.007.
    1. Kozak JA, Hanson GW, Rose JR, Trettin DM, Tullos HS. Anterior discectomy, microscopic decompression, and fusion: a treatment for cervical spondylotic radiculopathy. J Spinal Disord. 1989;2(1):43–46. doi: 10.1097/00002517-198903000-00006.
    1. Brigham CD, Tsahakis PJ. Anterior cervical foraminotomy and fusion. Surgical technique and results. Spine (Phila Pa 1976) 1995;20(7):766–770. doi: 10.1097/00007632-199504000-00004.
    1. Jagannathan J, Sherman JH, Szabo T, Shaffrey CI, Jane JA. The posterior cervical foraminotomy in the treatment of cervical disc/osteophyte disease: a single-surgeon experience with a minimum of 5 years’ clinical and radiographic follow-up. J Neurosurg Spine. 2009;10(4):347–356. doi: 10.3171/2008.12.SPINE08576.
    1. Ruetten S, Komp M, Merk H, Godolias G. Full-endoscopic cervical posterior foraminotomy for the operation of lateral disc herniations using 5.9-mm endoscopes: a prospective, randomized, controlled study. Spine (Phila Pa 1976) 2008;33(9):940–948. doi: 10.1097/BRS.0b013e31816c8b67.
    1. Lawton CD, Smith ZA, Lam SK, Habib A, Wong RH, Fessler RG. Clinical outcomes of microendoscopic foraminotomy and decompression in the cervical spine. World Neurosurg. 2014;81(2):422–427. doi: 10.1016/j.wneu.2012.12.008.
    1. Skovrlj B, Gologorsky Y, Haque R, Fessler RG, Qureshi SA. Complications, outcomes, and need for fusion after minimally invasive posterior cervical foraminotomy and microdiscectomy. Spine J. 2014;14(10):2405–2411. doi: 10.1016/j.spinee.2014.01.048.
    1. Kwon YJ. Long-term clinical and radiologic outcomes of minimally invasive posterior cervical foraminotomy. J Korean Neurosurg Soc. 2014;56(3):224–229. doi: 10.3340/jkns.2014.56.3.224.
    1. Branch BC, Hilton DL, Jr, Watts C. Minimally invasive tubular access for posterior cervical foraminotomy. Surg Neurol Int. 2015;6(1):81. doi: 10.4103/2152-7806.157308.
    1. Oertel JM, Philipps M, Burkhardt BW. Endoscopic posterior cervical foraminotomy as a treatment for osseous foraminal stenosis. World Neurosurg. 2016;91:50–57. doi: 10.1016/j.wneu.2016.02.073.
    1. Burkhardt BW, Muller S, Oertel JM. Influence of prior cervical surgery on surgical outcome of endoscopic posterior cervical foraminotomy for osseous foraminal stenosis. World Neurosurg. 2016;95:14–21. doi: 10.1016/j.wneu.2016.07.075.
    1. Peto I, Scheiwe C, Kogias E, Hubbe U. Minimally invasive posterior cervical foraminotomy: Freiburg experience with 34 patients. Clin Spine Surg. 2017;30(10):E1419–E1E25. doi: 10.1097/BSD.0000000000000517.
    1. Dunn C, Moore J, Sahai N, Issa K, Faloon M, Sinha K, et al. Minimally invasive posterior cervical foraminotomy with tubes to prevent undesired fusion: a long-term follow-up study. J Neurosurg Spine. 2018;29(4):358–64. 10.3171/2018.2.SPINE171003.
    1. Kim SJ, Seo JS, Lee SH, Bae J. Comparison of anterior cervical foraminotomy and posterior cervical foraminotomy for treating single level unilateral cervical radiculopathy. Spine (Phila Pa 1976) 2019;44(19):1339–1347. doi: 10.1097/BRS.0000000000003081.
    1. Clarke MJ, Ecker RD, Krauss WE, McClelland RL, Dekutoski MB. Same-segment and adjacent-segment disease following posterior cervical foraminotomy. J Neurosurg Spine. 2007;6(1):5–9. doi: 10.3171/spi.2007.6.1.2.
    1. MacDowall A, Heary RF, Holy M, Lindhagen L, Olerud C. Posterior foraminotomy versus anterior decompression and fusion in patients with cervical degenerative disc disease with radiculopathy: up to 5 years of outcome from the national Swedish spine register. J Neurosurg Spine. 2019:1–9.
    1. Kumar GR, Maurice-Williams RS, Bradford R. Cervical foraminotomy: an effective treatment for cervical spondylotic radiculopathy. Br J Neurosurg. 1998;12(6):563–568. doi: 10.1080/02688699844448.
    1. Grieve JP, Kitchen ND, Moore AJ, Marsh HT. Results of posterior cervical foraminotomy for treatment of cervical spondylitic radiculopathy. Br J Neurosurg. 2000;14(1):40–43. doi: 10.1080/02688690042898.
    1. Schoggl A, Reddy M, Saringer W, Ungersbock K. Social and economic outcome after posterior microforaminotomy for cervical spondylotic radiculopathy. Wien Klin Wochenschr. 2002;114(5-6):200–204.
    1. Spurling RG, Segerberg LH. Lateral intervertebral disk lesions in the lower cervical region. J Am Med Assoc. 1953;151(5):354–359.
    1. Frykholm R. Deformities of dural pouches and strictures of dural sheaths in the cervical region producing nerve-root compression; a contribution to the etiology and operative treatment of brachial neuralgia. J Neurosurg. 1947;4(5):403–413. doi: 10.3171/jns.1947.4.5.0403.
    1. Thome C, Leheta O, Krauss JK, Zevgaridis D. A prospective randomized comparison of rectangular titanium cage fusion and iliac crest autograft fusion in patients undergoing anterior cervical discectomy. J Neurosurg Spine. 2006;4(1):1–9. doi: 10.3171/spi.2006.4.1.1.
    1. Smith GW, Robinson RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958;40-A(3):607–624. doi: 10.2106/00004623-195840030-00009.
    1. Vernon H. The neck disability index: state-of-the-art, 1991-2008. J Manip Physiol Ther. 2008;31(7):491–502. doi: 10.1016/j.jmpt.2008.08.006.
    1. Burstrom K, Johannesson M, Diderichsen F. Swedish population health-related quality of life results using the EQ-5D. Qual Life Res. 2001;10(7):621–635. doi: 10.1023/A:1013171831202.
    1. Strömqvist B, Jönsson B, Froitzell P, Hägg O, Larsson B-E, Lind B. The Swedish national register for lumbar spine surgery: Swedish society for spinal surgery. Acta Orthop Scand. 2001;72(2):99–106. doi: 10.1080/000164701317323327.
    1. Parai C, Hagg O, Lind B, Brisby H. ISSLS prize in clinical science 2020: the reliability and interpretability of score change in lumbar spine research. Eur Spine J. 2020;29(4):663–669. doi: 10.1007/s00586-019-06222-8.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586. 10.1136/bmj.e7586.
    1. Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, Group CN CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167(1):40–47. doi: 10.7326/M17-0046.
    1. Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck disability index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010;10(6):469–474. doi: 10.1016/j.spinee.2010.02.007.
    1. Young IA, Cleland JA, Michener LA, Brown C. Reliability, construct validity, and responsiveness of the neck disability index, patient-specific functional scale, and numeric pain rating scale in patients with cervical radiculopathy. Am J Phys Med Rehabil. 2010;89(10):831–839. doi: 10.1097/PHM.0b013e3181ec98e6.
    1. Parker SL, Godil SS, Shau DN, Mendenhall SK, McGirt MJ. Assessment of the minimum clinically important difference in pain, disability, and quality of life after anterior cervical discectomy and fusion: clinical article. J Neurosurg Spine. 2013;18(2):154–160. doi: 10.3171/2012.10.SPINE12312.
    1. White AA, 3rd, Johnson RM, Panjabi MM. Southwick WO Biomechanical analysis of clinical stability in the cervical spine. Clin Orthop Relat Res. 1975;109:85–96. doi: 10.1097/00003086-197506000-00011.
    1. Stromqvist B, Fritzell P, Hagg O, Jonsson B, Swedish Society of Spinal S. The Swedish spine register: development, design and utility, Eur spine J. 2009;18(Suppl 3):294–304.
    1. Tyson JE, Pedroza C, Wallace D, D'Angio C, Bell EF, Das A. Stopping guidelines for an effectiveness trial: what should the protocol specify? Trials. 2016;17(1):240. doi: 10.1186/s13063-016-1367-4.
    1. White IR, Royston P, Wood AM. Multiple imputation using chained equations: issues and guidance for practice. Stat Med. 2011;30(4):377–399. doi: 10.1002/sim.4067.
    1. Sahai N, Changoor S, Dunn CJ, Sinha K, Hwang KS, Faloon M, et al. Minimally invasive posterior cervical foraminotomy as an alternative to anterior cervical discectomy and fusion for unilateral cervical radiculopathy: a systematic review and meta-analysis. Spine (Phila Pa 1976). 2019.
    1. MacDowall A, Canto Moreira N, Marques C, Skeppholm M, Lindhagen L, Robinson Y, et al. Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes. J Neurosurg Spine. 2019;30(3):323–31. 10.3171/2018.9.SPINE18659.
    1. Delamarter RB, Zigler J. Five-year reoperation rates, cervical total disc replacement versus fusion, results of a prospective randomized clinical trial. Spine (Phila Pa 1976) 2013;38(9):711–717. doi: 10.1097/BRS.0b013e3182797592.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅