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Total Disc Replacement Versus Anterior Cervical Decompression and Fusion (CERVIDISC)

Primary Purpose

Cervical Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgical treatment of cervical degenerative disc disease (CP ESP®)
Surgical treatment of cervical degenerative disc disease (Axelle®)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Degenerative Disc Disease focused on measuring Total Disc Replacement, Anterior Cervical Decompression and Fusion

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-60 years
  • suffering from cervical disc degenerative disease (whatever the grade, level and intervertebral disc height) needing one-level surgical treatment due to either invalidating cervicobrachial nevralgia despite 3-month optimal medical treatment or neurological symptoms, with motion of surgical level at least equal to 2° degrees, and non-degenerative adjacent discs.
  • Being affiliated to health insurance
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)

Exclusion Criteria:

  • Previous cervical traumatism and/or cervical surgery.
  • Cervical degeneration defined as a Grade 4 according to modified Mehren classification and/or a Grade 5 according to Miyazaki et al classification on T2 magnetic resonance imaging (MRI), at symptomatic level and/or its adjacent levels.
  • Myelopathy.
  • Cervical spine instability.
  • Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non-controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
  • Presence of at least one contraindication to either TDR or ACDF procedure.
  • Presence of at least one contraindication to either static/dynamic radiographs or Magnetic Resonance Imaging (MRI).
  • Severe radiological osteoporosis.
  • Bone metabolic disease.
  • Active cancer at time of inclusion into the study.
  • Chronic intake of corticosteroids or any other treatment susceptible to interfere with study conduct and/or assessment (ie, immunosuppressive drugs).
  • Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons.
  • No contraception for women of childbearing age
  • Pregnant or breastfeeding women
  • Being under guardianship or legal supervision.

Sites / Locations

  • Chirurgie Orthopedique
  • CHU Nice - Unité de Chirurgie Rachidienne
  • Chirurgie Orthopedique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Total disc replacement (TDR)

Anterior Cervical Decompression and Fusion (ACDF)

Arm Description

Total disc replacement with preserved segmental motion decreasing load on adjacent levels.

Interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace.

Outcomes

Primary Outcome Measures

To compare efficacy of TDR and ACDF as surgical treatment of cervical degenerative disc disease in term of "success rate" defined as absence of radiological degenerative disease at adjacent levels

Secondary Outcome Measures

Between-group comparison of tolerance
This measure is a composite with : Per- and post-operative surgery parameters Major complication rate Minor complication rate
Between-group comparison of efficacy
This measure is a composite with : Cervical and radicular pain outcome as compared to preoperative status. Functional outcome: Neck Disability Index (NDI) and modified Prolo Economic and Functional scores as compared to preoperative status. Cervical radiological parameters Quality of life outcome as compared to preoperative status.

Full Information

First Posted
January 28, 2015
Last Updated
December 10, 2021
Sponsor
University Hospital, Bordeaux
Collaborators
Ministry for Health and Solidarity, France
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1. Study Identification

Unique Protocol Identification Number
NCT02417272
Brief Title
Total Disc Replacement Versus Anterior Cervical Decompression and Fusion
Acronym
CERVIDISC
Official Title
Comparison of 2 Surgical Approaches in the Treatment of Cervical Degenerative Disc Disease: Total Disc Replacement Versus Anterior Cervical Decompression and Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2015 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Ministry for Health and Solidarity, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background : Cervical degenerative disc disease is frequent and the consequence of aging. Degeneration may lead to disc herniation. Surgery is indicated in the presence of root compression with cervicobrachial neuralgia and/or myelopathy. Purpose: The main objective of the study is the comparison of efficacy between total disc replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment of symptomatic cervical degenerative disc disease in term of "Success" rate, defined as preservation of adjacent segments, 24 months after surgery. In our knowledge, there are no published data about randomized clinical trials comparing these radiological parameters (worsening of degeneration signs on static cervical spine radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery, between these 2 surgical approaches in patients suffering from cervical degenerative disc disease.
Detailed Description
Surgical treatment of cervical degenerative disc disease usually consists in neural decompression followed by intervertebral space reconstruction. ACDF consists in interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace. Fusion is successful in approximately 95% of patients with good to excellent clinical results in most of them. Unfortunately, up to 25% of these patients will develop degenerative changes at adjacent levels after surgery. TDR consists in total disc replacement with preserved segmental motion decreasing load on adjacent levels. Worsening of radiological degeneration signs at adjacent levels seems to be an important long term prognostic factor for reoperation. In this trial, included patients will be randomly assigned to undergo either TDR or ACDF Six visits are planned during the study: pre inclusion visit within 3 months before surgery, inclusion/randomisation the day before surgery, 3 follow up visits (45 days, 6, and 12 months after surgery) and an end of study visit 24 months after surgery (or at time of withdrawal if relevant).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Degenerative Disc Disease
Keywords
Total Disc Replacement, Anterior Cervical Decompression and Fusion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total disc replacement (TDR)
Arm Type
Experimental
Arm Description
Total disc replacement with preserved segmental motion decreasing load on adjacent levels.
Arm Title
Anterior Cervical Decompression and Fusion (ACDF)
Arm Type
Experimental
Arm Description
Interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace.
Intervention Type
Device
Intervention Name(s)
Surgical treatment of cervical degenerative disc disease (CP ESP®)
Intervention Type
Device
Intervention Name(s)
Surgical treatment of cervical degenerative disc disease (Axelle®)
Intervention Description
Axelle®
Primary Outcome Measure Information:
Title
To compare efficacy of TDR and ACDF as surgical treatment of cervical degenerative disc disease in term of "success rate" defined as absence of radiological degenerative disease at adjacent levels
Time Frame
24 months after surgery
Secondary Outcome Measure Information:
Title
Between-group comparison of tolerance
Description
This measure is a composite with : Per- and post-operative surgery parameters Major complication rate Minor complication rate
Time Frame
24 months after surgery
Title
Between-group comparison of efficacy
Description
This measure is a composite with : Cervical and radicular pain outcome as compared to preoperative status. Functional outcome: Neck Disability Index (NDI) and modified Prolo Economic and Functional scores as compared to preoperative status. Cervical radiological parameters Quality of life outcome as compared to preoperative status.
Time Frame
45 days, 6, 12 and 24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-60 years suffering from cervical disc degenerative disease (whatever the grade, level and intervertebral disc height) needing one-level surgical treatment due to either invalidating cervicobrachial nevralgia despite 3-month optimal medical treatment or neurological symptoms, with motion of surgical level at least equal to 2° degrees, and non-degenerative adjacent discs. Being affiliated to health insurance Having signed an informed consent (later than the day of inclusion and before any examination required by research) Exclusion Criteria: Previous cervical traumatism and/or cervical surgery. Cervical degeneration defined as a Grade 4 according to modified Mehren classification and/or a Grade 5 according to Miyazaki et al classification on T2 magnetic resonance imaging (MRI), at symptomatic level and/or its adjacent levels. Myelopathy. Cervical spine instability. Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non-controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection). Presence of at least one contraindication to either TDR or ACDF procedure. Presence of at least one contraindication to either static/dynamic radiographs or Magnetic Resonance Imaging (MRI). Severe radiological osteoporosis. Bone metabolic disease. Active cancer at time of inclusion into the study. Chronic intake of corticosteroids or any other treatment susceptible to interfere with study conduct and/or assessment (ie, immunosuppressive drugs). Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons. No contraception for women of childbearing age Pregnant or breastfeeding women Being under guardianship or legal supervision.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olivier GILLE, Prof
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chirurgie Orthopedique
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Nice - Unité de Chirurgie Rachidienne
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Chirurgie Orthopedique
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

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Total Disc Replacement Versus Anterior Cervical Decompression and Fusion

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