Adjacent Segment Disease After Anterior Cervical Decompression Surgery

NCT04320043 | Completed

• 1 other identifier: METCZ2020004
• Study Type: observational
• Target: 673
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adjacent Segment Disease; Cervical Myelopathy; Cervical Radiculopathy; Degenerative Disc Disease

Keywords

Adjacent Segment Disease; Anterior Cervical Discectomy; Anterior Cervical Discectomy with Fusion; ACD; ACDF; Cervical Radiculopathy; Cervical Myelopathy; Degenerative Disc Disease; Discectomy; Corpectomy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

  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.

Other Outcomes (1)

• The occurrence of complications related to surgery

  Available patient records from primary intervention (10 years in retrospective) until present or death will be analysed.

Study Arms (1)

Anterior cervical decompression surgery

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.

Procedure: Anterior cervical decompression

Interventions

Anterior cervical decompression PROCEDURE

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

Anterior cervical decompression surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients with symptomatic single-level or multi-level radiculopathy and/or myelopathy due to CDDD, which corresponds to the afflicted level on radiologic imaging.
• Neurosurgical technique used: anterior cervical discectomy (simple discectomy, ACD), anterior cervical discectomy with fusion (ACDF) with or without plating, corpectomy.
• Minimum age 18 years.
• Adequately documented treatment.
• Follow up data available in electronic patients records for at least one outpatient follow-up visit weeks post-operative

You may not qualify if:

• Any other cause than degenerative disc disease for radiculopathy and/or myelopathy such as compression by spinal tumours, trauma, infection or rheumatologic pathologies.
• Objection to participate in scientific research.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Maastricht University Medical Center: collaborator

Study Sites (1)

Zuyderland Medisch Centrum

Heerlen, Limburg, 6419 PC, Netherlands

Location

Related Publications (14)

• 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.

  PMID: 25839387 BACKGROUND

• 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.

  PMID: 29284641 BACKGROUND

• 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.

  PMID: 19812130 BACKGROUND

• 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.

  PMID: 8875719 BACKGROUND

• 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.

  PMID: 29164035 BACKGROUND

• 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.

  PMID: 29164034 BACKGROUND

• 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.

  PMID: 10413119 BACKGROUND

• 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.

  PMID: 10225797 BACKGROUND

• 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.

  PMID: 23420004 BACKGROUND

• 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.

  PMID: 15541666 BACKGROUND

• 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.

  PMID: 24010901 BACKGROUND

• 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.

  PMID: 26824587 BACKGROUND

• 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.

  PMID: 29372135 BACKGROUND

• 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.

  PMID: 28142256 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Henk van Santbrink, MD, PhD, prof

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 24, 2020
• Study Start: March 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

NL (1)