Degenerative Disc Disease Clinical Trial
— ASDafterACDFOfficial title:
The Risk of Adjacent Segment Disease After Anterior Cervical Discectomy With Fusion for Cervical Degenerative Disc Disease
NCT number | NCT04320043 |
Other study ID # | METCZ2020004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | October 1, 2020 |
Verified date | November 2020 |
Source | Zuyderland Medisch Centrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 673 |
Est. completion date | October 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Zuyderland Medisch Centrum | Heerlen | Limburg |
Lead Sponsor | Collaborator |
---|---|
Zuyderland Medisch Centrum | Maastricht University Medical Center |
Netherlands,
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. — View Citation
Dowd GC, Wirth FP. Anterior cervical discectomy: is fusion necessary? J Neurosurg. 1999 Jan;90(1 Suppl):8-12. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017 Nov 28;11:31. doi: 10.14444/4031. eCollection 2017. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The occurrence of complications related to surgery | Assessing whether complications related to surgery occurred, classified as none/failure of treatment/death. | Available patient records from primary intervention (10 years in retrospective) until present or death will be analysed. | |
Primary | 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 | 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. | Measured in patients that underwent primary intervention for cervical radiculopathy due to cervical degenerative disc disease. Assessing whether radiculopathy improved (good outcome) or deteriorated/stabilized (poor outcome), as described by a neurosurgeon or neurosurgical resident in patient records. | Available patient records from the primary intervention (10 years in retrospective) until present time will be analysed. | |
Secondary | 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. | Measured in patients that underwent primary intervention for cervical myelopathy due to cervical degenerative disc disease. Assessing whether myelopathy improved/stabilized (good outcome) or deteriorated (poor outcome), as described by a neurosurgeon or neurosurgical resident in patient records. | Available patient records from primary intervention (10 years in retrospective) until present time will be analysed. | |
Secondary | New symptoms | Assessing whether patients developed new symptoms (yes/no) after the primary treatment, radiculopathy or myelopathy and the affected level. | Available patient records from primary intervention (10 years in retrospective) until present will be analysed. |
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