NCT03950349

FUSION EVALUATION AFTER ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH STAND ALONE LOCKING CAGE WITH BLADE HRCC®

Status unknown Last updated 15 May 2019

What this trial tests

trial in Cervical Radiculopathy in 50 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
1 July 2019

1 January 2021

Quick facts

Lead sponsor	CHU de Reims
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	50
Start date	1 January 2019
Primary completion	1 July 2019
Estimated completion	1 January 2021
Sites	1 location across France

Conditions studied

• Cervical Radiculopathy — all drugs for Cervical Radiculopathy →
• Cervical Spinal Fusion — all drugs for Cervical Spinal Fusion →
• Cervical Myelopathy — all drugs for Cervical Myelopathy →

Sponsor

CHU de Reims — full company profile →

Who can join

18 and older, any sex, with Cervical Radiculopathy or Cervical Spinal Fusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cervical degenerative disease is an almost universal concomitant of human aging. Over half of the middle aged population has cervical spondylosis. This condition is often asymptomatic, but in 10% to 15% of the cases, it is associated with, or progresses to, neural compression. Cervical spondylotic radiculopathy is a condition due to a root nerve compression while cervical spondylotic myelopathy is a condition due to a medullar cord compression. Root nerve or medullar cord can be compressed either by a soft disc extrusion or by arthrosis due to a degenerative disc. Anterior cervical discectomy and fusion is the standard surgical treatment of the cervical radiculopathy or cervical myelopathy when non-surgical treatment failed. The aim of this surgery is to provide a neurologic decompression associated to spine stabilization. Decompression is achieved by removal the disc and soft disc extrusion if present. Stabilization is supported by implantation of material in the interbody space like bone or cage with bone substitute. This cage provides a bone fusion matrix and an intervertebral height and stability support at the same time. To enforce the stabilization, a plate can be screwed on the anterior cervical vertebral wall. The HRCC® cage is a stand-alone cage with two rotary blades which penetrate into vertebral bone so there is no need to implant plate. One of the reasons why treatment can fail is the pseudarthrosis that is fusion failure. It mays occur as an increase of axial pain or radicular pain. The aim of this study is to demonstrate similar results on bone fusion in the surgical treatment of cervical radiculopathy or myelopathy with HRCC cage used in anterior cervical discectomy and fusion compared with other technics based on a prospective cohort study and a literature review. As secondary outcomes we will search to correlate pseudarthrosis and quality of life impact, to identify complications and to describe the sagittal balance evolution of the cervical spine. To this end, in the context of standard practices, patients who consult the neurosurgical team of the REIMS University Hospital Center with a diagnosis of a cervical radiculopathy or myelopathy with non-surgical treatment failure needing a one level anterior cervical discectomy and fusion will be proposed to be included during this pre-operative consultation. There will be pre-operative collected data about demographic data, pseudarthrosis risk factors, pre-operative symptomatology, quality of life data and pre-operative imagery data. Per-operative and hospitalization data are collected as well with surgery duration, blood lost, surgical technic, pain measurement and hospitalization duration. Next, follow-up starts with consultations at 6 weeks, 6 months and 12 months and pain, quality of life and classic X-Ray data are collected to be compared with pre-operative data. And Imagery data are collected in order to identify presence or absence of pseudarthrosis with dynamic X-Ray and CT-scan at 6 months and 12 months. A statistical analysis of the data is next performed to found significant results.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Complication and Infection Risk Using Bone Substitute Materials to Treat Long Bone Defects in Geriatric Patients: An Observational Study.
   Pawelke J, Vinayahalingam V, El Khassawna T, Heiss C, et al · · 2023 · cited 8× · PMID 36837565 · DOI 10.3390/medicina59020365