ASDafterACDF
The Risk of Adjacent Segment Disease After Anterior Cervical Discectomy With Fusion for Cervical Degenerative Disc Disease
Sponsor study identifier
observational
673
1 country
1
Study Start
March 1, 2020
Actual (reported)Primary Completion
July 1, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)Radiculopathy and/or myelopathy due to cervical degenerative disc disease are increasingly common pathologies in our ageing population. Both can be treated non-surgically or surgically. The most commonly used neurosurgical treatment is anterior cervical discectomy with or without fusion. The goal is to achieve neural decompression of the operated segment in both procedures. However, due to this fusion and reduced mobility of the cervical spine at the level of the intervention, adjacent segment disease may occur. This can lead to new symptoms like radiculopathy and/or myelopathy at an adjacent level which requires reoperation in about 2/3 of patients. Reoperations are burdensome for patients and have a socio-economic impact due to the costs of hospital admissions, operations, and secondary costs such as work-absenteeism. The primary objective of this retrospective study is to determine the occurrence of adjacent segment disease after a single- or multi-level anterior cervical discectomy with fusion procedure for radiculopathy and/or myelopathy in the investigators' centre and to compare this to the incidence in literature. The investigators also look at the risk of adjacent segment disease after different anterior surgical techniques, such as anterior cervical discectomy, anterior cervical discectomy with fusion and plating, and corpectomy. As a secondary outcome they aim to determine risk factors predicting the occurrence of adjacent segment disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2020
Actual (reported)March 11, 2020
Actual (reported)March 24, 2020
Actual (reported)July 1, 2020
Actual (reported)October 1, 2020
Actual (reported)The incidence of re-operation for adjacent segment disease
Assessing whether a patient underwent a re-operation for ASD (yes/no) after the primary intervention for radiculopathy and/or myelopathy due to cervical degenerative disc disease. To determine this, patient records will be analysed.
Available patient records from the primary intervention (10 years in retrospective) until present time will be analysed.
Radiculopathy: the number of patients with a good outcome and the number of patients with a poor outcome among those who underwent an intervention for radiculopathy.
Available patient records from the primary intervention (10 years in retrospective) until present time will be analysed.
Myelopathy: the number of patients with a good outcome and the number of patients with a poor outcome among those who underwent an intervention for myelopathy.
Adult patients who underwent anterior cervical decompression surgery for radiculopathy and/or myelopathy due to cervical degenerative disc disease. Patients underwent one of the following interventions: ACD, ACDF, ACDF with plating or corpectomy.
Any of the following anterior surgical techniques used to decompress the cervical nerve roots or spinal cord; corpectomy, Anterior Cervical Discectomy (ACD), Anterior Cervical Decompression and Fusion (ACDF) or ACDF with Plating
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population consists of adult patients who underwent anterior cervical decompression for radiculopathy and/or myelopathy due to cervical degenerative disc disease in the Zuyderland MC Heerlen or Maastricht UMC+ in the past 10 years. Anterior surgical decompression techniques that will be included are ACD, ACDF, ACDF with plating and corpectomy.
Zuyderland Medisch Centrum
Heerlen, Limburg, 6419 PC, Netherlands
Nouri A, Tetreault L, Singh A, Karadimas SK, Fehlings MG. Degenerative Cervical Myelopathy: Epidemiology, Genetics, and Pathogenesis. Spine (Phila Pa 1976). 2015 Jun 15;40(12):E675-93. doi: 10.1097/BRS.0000000000000913.
McCartney S, Baskerville R, Blagg S, McCartney D. Cervical radiculopathy and cervical myelopathy: diagnosis and management in primary care. Br J Gen Pract. 2018 Jan;68(666):44-46. doi: 10.3399/bjgp17X694361. No abstract available.
Henk van Santbrink, MD, PhD, prof
Maastricht University Medical Centre
673 participants (actual enrollment reported by the registry).
First Submitted
March 11, 2020
First Posted
March 24, 2020
Study Start
March 1, 2020
Actual (reported)Investigation in Integrated Perspective of Radiculomyelopathy Patients
Available patient records from primary intervention (10 years in retrospective) until present time will be analysed.
New symptoms
Available patient records from primary intervention (10 years in retrospective) until present will be analysed.
The occurrence of complications related to surgery
Available patient records from primary intervention (10 years in retrospective) until present or death will be analysed.
Contact the study team to confirm eligibility.
Kuijper B, Tans JT, Beelen A, Nollet F, de Visser M. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial. BMJ. 2009 Oct 7;339:b3883. doi: 10.1136/bmj.b3883.
Saal JS, Saal JA, Yurth EF. Nonoperative management of herniated cervical intervertebral disc with radiculopathy. Spine (Phila Pa 1976). 1996 Aug 15;21(16):1877-83. doi: 10.1097/00007632-199608150-00008.
Fehlings MG, Tetreault LA, Riew KD, Middleton JW, Aarabi B, Arnold PM, Brodke DS, Burns AS, Carette S, Chen R, Chiba K, Dettori JR, Furlan JC, Harrop JS, Holly LT, Kalsi-Ryan S, Kotter M, Kwon BK, Martin AR, Milligan J, Nakashima H, Nagoshi N, Rhee J, Singh A, Skelly AC, Sodhi S, Wilson JR, Yee A, Wang JC. A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression. Global Spine J. 2017 Sep;7(3 Suppl):70S-83S. doi: 10.1177/2192568217701914. Epub 2017 Sep 5.
Fehlings MG, Kwon BK, Tetreault LA. Guidelines for the Management of Degenerative Cervical Myelopathy and Spinal Cord Injury: An Introduction to a Focus Issue. Global Spine J. 2017 Sep;7(3 Suppl):6S-7S. doi: 10.1177/2192568217701714. Epub 2017 Sep 5.
Dowd GC, Wirth FP. Anterior cervical discectomy: is fusion necessary? J Neurosurg. 1999 Jan;90(1 Suppl):8-12. doi: 10.3171/spi.1999.90.1.0008.
Hilibrand AS, Carlson GD, Palumbo MA, Jones PK, Bohlman HH. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am. 1999 Apr;81(4):519-28. doi: 10.2106/00004623-199904000-00009.
Helgeson MD, Bevevino AJ, Hilibrand AS. Update on the evidence for adjacent segment degeneration and disease. Spine J. 2013 Mar;13(3):342-51. doi: 10.1016/j.spinee.2012.12.009. Epub 2013 Feb 15.
Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J. 2004 Nov-Dec;4(6 Suppl):190S-194S. doi: 10.1016/j.spinee.2004.07.007.
Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
Radcliff K, Lerner J, Yang C, Bernard T, Zigler JE. Seven-year cost-effectiveness of ProDisc-C total disc replacement: results from investigational device exemption and post-approval studies. J Neurosurg Spine. 2016 May;24(5):760-8. doi: 10.3171/2015.10.SPINE15505. Epub 2016 Jan 29.
Radcliff K, Davis RJ, Hisey MS, Nunley PD, Hoffman GA, Jackson RJ, Bae HW, Albert T, Coric D. Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C(c) Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017 Nov 28;11(4):31. doi: 10.14444/4031. eCollection 2017.
Joaquim AF, Riew KD. Multilevel cervical arthroplasty: current evidence. A systematic review. Neurosurg Focus. 2017 Feb;42(2):E4. doi: 10.3171/2016.10.FOCUS16354.
Primary Completion
July 1, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)Last Updated
November 18, 2020
Record last verified: 2020-11
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