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

NCT03950349 | Unknown

• 1 other identifier: PO18157
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Radiculopathy; Cervical Spinal Fusion; Cervical Myelopathy

Keywords

Radiculopathy; myelopathy; anterior cervical fusion; stand-alone cage; pseudoarthrosis; stabilization; HRCC

Outcome Measures

Primary Outcomes (2)

• Pseudarthrosis

  Pseudarthrosis diagnosis is comfirmed if : * CT-scan documents an absence of bone bridging in the extra-graft area * measurement of the spinous process shift which is the difference between the inter-spinous process distance on the flexion image and the inter-spinous process distance on the extension image. It is positive when it is more than 1mm at the arthrodesis level associated with a more than 4mm spine process shift at adjacent superior and inferior levels on dynamic cervical X-Ray.

  6 months

• Pseudarthrosis

  Pseudarthrosis diagnosis is comfirmed if : * CT-scan documents an absence of bone bridging in the extra-graft area * measurement of the spinous process shift which is the difference between the inter-spinous process distance on the flexion image and the inter-spinous process distance on the extension image. It is positive when it is more than 1mm at the arthrodesis level associated with a more than 4mm spine process shift at adjacent superior and inferior levels on dynamic cervical X-Ray.

  12 months

Study Arms (1)

"Anterior cervical discectomy" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who consult the neurosurgical team of the REIMS University Hospital Center with diagnosis of one level cervical discopathy causing cervical radiculopathy or myelopathy with non-surgical treatment failure needing a one level anterior cervical discectomy and fusion.

You may qualify if:

• Diagnosis of one level cervical discopathy causing cervical radiculopathy or myelopathy with non-surgical treatment failure needing a one level anterior cervical discectomy and fusion
• Age \> 18 years old
• Agree to take part at this study

You may not qualify if:

• More than one intervertebral level needs to be fused
• Antecedent of spine cervical fracture
• Active cervical malignancy
• Antecedent of cervical spine surgery

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Klippel-Feil Syndrome; Spinal Cord Diseases; Pseudarthrosis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Central Nervous System Diseases; Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Central Study Contacts

Claude-Fabien LITRE

CONTACT

03 26 78 76 59; flitre@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: January 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2021
• Last Updated: May 15, 2019

Record last verified: 2019-04

Locations

FR (1)