Dataset Information

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

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.

SUBMITTER: Holy M

PROVIDER: S-EPMC8425018 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Posterior cervical decompression and fusion (PCF) is a common surgical technique used to treat various cervical spine pathologies. However, there are various complications associated with PCF that can negatively impact patient outcome. We performed a comprehensive literature review to identify the most common complications following PCF using PubMed, Cochrane Database of Systematic Reviews, and Google Scholar. The overall complication rates of PCF are estimated to range from about 15% to 25% in the current literature. The most common immediate complications include acute blood loss anemia, surgical site infection (SSI), C5 palsy, and incidental durotomy; the most common long-term complications include adjacent segment degeneration, junctional kyphosis, and pseudoarthrosis. Three principal mechanisms are thought to contribute to complications. First, higher number of fusion levels, obesity, and more complex pathologies can increase the invasiveness of the planned procedure, thus increase complications. Second, wound healing and arthrodesis may be impaired due to poor blood flow due to various patient factors such as smoking, diabetes, increased frailty, steroid use, and other medical comorbidities. Finally, increased biomechanical stress on the upper instrumented vertebra (UIV) and lowest instrumented vertebra (LIV) may predispose patient to chronic degeneration and result in adjacent level degeneration and/or junctional problems. Reducing the modifiable risk factors pre-operatively can decrease the overall complication rate. Neurologic deficits may be reduced with adequate intraoperative decompression of neural elements. SSI may be reduced with meticulous wound closure that minimizes dead space, drain placement, and the use of intra-wound antibiotics. Careful design of the fusion construct with consideration in spinal alignment and biomechanics can help to reduce the rate of junctional problems. Spine surgeons should be aware of these complications associated with PCF and the corresponding prevention strategies optimize patient outcomes.