RecruitingACTRN12618000882224

Does metal plating reduce the degree of disc collapse following anterior spinal surgery

Subsidence after plating in anterior cervical discectomy and fusion for cervical spondylosis: A phase 3, single-blinded randomised control trial.


Sponsor

Mr. Nova Thani

Enrollment

200 participants

Start Date

Sep 11, 2018

Study Type

Interventional

Conditions

Summary

The Anterior Cervical Discectomy and Fusion (ACDF) is one of the most common operations utilised in treating cervical degenerative disc disease. This involves removal of an intervertebral disc and cartilage with surrounding bone removal to release compressed spinal nerves. Once the disc has been removed, an implant known as an ‘inter-body cage’ is introduced into the disc space to restore disc height with restoration of physiological alignment and create an environment to achieve bony fusion. Overall, this procedure aims to improve neck pain and nerve pain via neural decompression and improved stabilisation. One of the inherent problems with introducing an implant that is more resistant to compressive forces (i.e. an increased bulk modulus) when compared to vertebral bodies is subsidence. Subsidence involves the ‘sinking’ of an implant postoperatively into vertebral bodies over time. Radiologically, this is the distance measured between two vertebral bodies at the segment of interest. This can result in narrowing if the neural exit foramen and development of pathological alignment leading to recurrence of symptoms. Furthermore, adjacent levels are subjected to abnormal biomechanical stresses, ultimately leading to development of further issues. Early subsidence can also lead to increased mobility in the segment and lead to failure in fusion. Currently, there lacks consensus on the definition of subsidence, with reported parameters of radiological subsidence varying amongst publications, thus making comparison between studies difficult. Generally, it is accepted that subsidence has occurred when there is an absolute loss of 2-4mm in interbody height, or a 10% reduction in interbody height, when compared to cervical x-rays performed immediately postoperatively. Subsequent to the introduction of the ACDF utilising a standalone cage, the operation has been augmented by the addition of a metal, anterior cervical plate. By bridging the anterior aspect of a fused segment, this was shown to supplement the cage leading to increased fusion rates and better stability. However, some of the disadvantages associated with use of a plate included post-operative dislodgement, soft-tissue injury and dysphagia. Currently, there is no consensus over whether anterior cervical plating offers any added benefit, hence the need for this trial.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at a common neck surgery called Anterior Cervical Discectomy and Fusion (ACDF), which removes a damaged disc between the bones of the neck to relieve pressure on spinal nerves. After the disc is taken out, a small implant called an inter-body cage is placed in the gap to restore normal spacing and allow the bones to fuse together. The goal is to reduce neck and arm pain by stabilising the spine. One of the challenges with this surgery is "subsidence" — where the cage slowly sinks into the surrounding bone over time, potentially causing the disc space to narrow again and symptoms to return. Surgeons sometimes add a metal plate across the front of the spine to help prevent this, but there is disagreement about whether the plate actually makes a meaningful difference. This trial is comparing outcomes between patients who receive the cage alone versus those who also get the metal plate. You may be eligible if you are 18 or older and your surgeon has recommended a one- or two-level ACDF procedure for cervical disc disease. People who have had previous neck surgery or whose surgery is for a traumatic injury are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

All eligible patients will undergo an anterior cervical discetomy and fusion based on the Smith-Robinson technique, which is well described in the literature. Arm 1 (Exposure) = Anterior Cervical Pl

All eligible patients will undergo an anterior cervical discetomy and fusion based on the Smith-Robinson technique, which is well described in the literature. Arm 1 (Exposure) = Anterior Cervical Plate (ACP) group Arm 2 (Control) = Standalone Cage (ASA) group Arm 1: - All patients receive information regarding the clinical trial, including an information sheet regarding operative details. - Patients will all undergo preoperative and postoperative assessment, including the completion of clinical metrics that evaluate preoperative disability. This activity is delivered via an electronic survey and paper-based checklists. This occurs once pre-operatively, as well as at the 3, 6 and 12 month mark post-operatively. - Patients will then undergo an ACDF as per the technique described above. Intraoperatively, patients in Arm 1 will have an anterior cervical metallic plate placed. This procedure is completed by a consultant neurosurgeon who is a fellow with the Royal Australasian College of Surgeons (RACS). - All interventions will occur at Calvary Healthcare Lenah Valley, a private hospital. - Monitoring fidelity to the intervention is not applicable because the intervention is delivered intra-operatively with regards to whether or not a patient receives the surgical implant described. Patient follow up will be facilitated by email/phone call reminders to attend outpatient clinics.


Locations(1)

Calvary Health Care Tasmania - Hobart - Lenah Valley

TAS, Australia

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ACTRN12618000882224


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