CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 673 enrolled
Drug / intervention
Anterior cervical decompressionprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04320043
NCT04320043N/ACompleted

The Risk of Adjacent Segment Disease After Anterior Cervical Discectomy With Fusion for Cervical Degenerative Disc Disease

Zuyderland Medisch Centrum·observational·Posted Mar 24, 2020·Updated Nov 18, 2020

In Brief

An observational study evaluating Anterior cervical decompression for Adjacent Segment Disease and 3 related conditions. Completed, enrolled 673 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 24, 2020
Enrollment StartMar 1, 2020
Primary CompletionJul 1, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.3 years ago

Interventions

Anterior cervical decompressionprocedure

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