Dataset Information

Clinical evaluation of enhanced recovery after surgery protocol for anterior cervical decompression and fusion (ACDF): study protocol for a multicentre randomised controlled trial.

ABSTRACT:

Introduction

To improve the efficacy of anterior cervical decompression and fusion (ACDF) and reduce postoperative complications in degenerative cervical myelopathy, our team established a set of perioperative care of enhanced recovery guidelines of ACDF based on the concept of enhanced recovery after surgery. In addition, a prospective, multicentre, randomised clinical trial was designed.

Methods and analysis

A total of 260 patients aged 18-65 years will be included. Preoperative MRI and CT will be used to confirm the typical manifestations of cervical spondylosis, such as cervical disc herniation and spinal cord compression. The patient presents with neck and shoulder pain, numbness of upper limbs, weakened grip strength and cotton sense of foot tread. Patients received normal conservative treatment for 3 months with no obvious relief or even aggravation of symptoms. Patients will be assigned to the group in strict accordance with the random allocation table. Patients in groups A and B will receive conventional perioperative care and perioperative care for enhanced recovery, respectively. The main outcome indicators are the Karnofsky Performance Scale score and the Japanese Orthopaedic Association scale. Secondary outcome indicators are pain assessment by Numeric Rating Scale, Neck Disability Index, quality of life index (QL-Index) and postoperative complications. Follow-up will be conducted at 3, 6 and 12 months postoperatively.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2020YF034-01). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences.

Trial registration number

ChiCTR2000040508.

SUBMITTER: Zhong GQ

PROVIDER: S-EPMC8444256 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionTo date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term.Methods and analysisIn this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery.DiscussionHigh-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question.Trial registrationClinicalTrials.gov NCT04623593. Registered on 29 September 2020.

Project description:BackgroundNowadays, anterior cervical artificial disc replacement (ACDR) has achieved favorable outcomes in treatment for patients with single-level cervical spondylosis. However, It is still controversial that whether or not it will become a potent therapeutic alternation in treating 2 contiguous levels cervical spondylosis compared with anterior cervical decompression and fusion (ACDF). Therefore, we conducted a systematic review and meta-analysis to compare the efficacy and safety of ACDR and ACDF in patients with 2 contiguous levels cervical spondylosis.MethodsAccording to the computer-based online search, PubMed, Embase, Web of Science, and Cochrane Library for articles published before July 1, 2017 were searched. The following outcome measures were extracted: neck disability index (NDI), visual analog scale (VAS) neck, VAS arm, Short Form (SF)-12 mental component summary (MCS), SF-12 physical component summary (PCS), overall clinical success (OCS), patient satisfaction (PS), device-related adverse event (DRAE), subsequent surgical intervention (SSI), neurological deterioration (ND), and adjacent segment degeneration (ASD). Methodological quality was evaluated independently by 2 reviewers using the Furlan for randomized controlled trial (RCT) and MINORS scale for clinical controlled trials (CCT). The chi-squared test and Higgin I test were used to evaluate the heterogeneity. A P?<?.10 for the chi-squared test or I values exceeding 50% indicated substantial heterogeneity and a random-effect model was applied; otherwise, a fixed-effect model was used. All quantitative data were analyzed by the Review Manager 5.2 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark).ResultsNine RCTs and 2 CCT studies containing 2715 patients were included for this meta-analysis. The pooled analysis indicated that the ACDR group is superior to ACDF in NDI, VAS neck, PCS score, OCS, PS, DRAE, ASD, and SSI. However, the pooled results indicate that there was no significant difference in the ND, VAS arm and in MCS score.ConclusionsThe present meta-analysis suggests that for bi-level cervical spondylosis, ACDR appears to provide superior clinical effectiveness and safety effects than ACDF. In the future, more high-quality RCTs are warranted to enhance this conclusion.

Project description:BackgroundDespite being considered the standard surgical procedure for symptomatic cervical disc disease, anterior cervical decompression and fusion invariably accelerates adjacent segment degeneration. Cervical total disc replacement is a motion-preserving procedure developed as a substitute to fusion. Whether cervical total disc replacement is superior to fusion remains unclear.MethodsWe comprehensively searched PubMed, EMBASE, Medline, and the Cochrane Library in accordance with the inclusion criteria to identify possible studies. The retrieved results were last updated on December 12, 2014. We classified the studies as short-term and midterm follow-up.ResultsNineteen randomized controlled trials involving 4516 cases were identified. Compared with anterior cervical decompression and fusion, cervical total disc replacement had better functional outcomes (neck disability index [NDI], NDI success, neurological success, neck pain scores reported on a numerical rating scale [NRS], visual analog scales scores and overall success), greater segmental motion at the index level, fewer adverse events and fewer secondary surgical procedures at the index and adjacent levels in short-term follow-up (P < 0.05). With midterm follow-up, the cervical total disc replacement group indicated superiority in the NDI, neurological success, pain assessment (NRS), and secondary surgical procedures at the index level (P < 0.05). The Short Form 36 (SF-36) and segmental motion at the adjacent level in the short-term follow-up showed no significant difference between the two procedures, as did the secondary surgical procedure rates at the adjacent level with midterm follow-up (P > 0.05).ConclusionsCervical total disc replacement presented favorable functional outcomes, fewer adverse events, and fewer secondary surgical procedures. The efficacy and safety of cervical total disc replacement are superior to those of fusion. Longer-term, multicenter studies are required for a better evaluation of the long-term efficacy and safety of the two procedures.

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