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Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse

Primary Purpose

Intervertebral Disc Displacement

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Anterior cervical discectomy with prosthetic disc replacement / ESP.
Anterior cervical discectomy with prosthetic disc replacement / Rotaio.
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervertebral Disc Displacement

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis

Exclusion Criteria:

  • Radiologic signs of extensive bone degeneration in the affected segment
  • Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software
  • Transversal spine cord lesion
  • Cervical myelopathy
  • Preceding surgery on the cervical spine
  • Traumatic lesions of the cervical spine
  • Radiographic instability in the affected segment: flexion / extension: shift sagittal plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation > 11º
  • signs of instability (Olisthesis) in another segment of the cervical spine
  • Active systemic infection
  • diseases of the rheumatic type and all autoimmune diseases
  • bone metabolic diseases (for example, Paget's disease)
  • skeletal metastases
  • infections in the cervical spine
  • Neurological seizure disorders or other serious neurological disease with risk of falls
  • Severe heart failure (NYHA III-IV)
  • Bleeding disorders or clopidogrel / coumarins - treatment
  • Systemic use of corticosteroids for more than a month in the last 12 months
  • Pregnancy
  • Legally incompetent patient
  • Lactation
  • Deformity, anomalies, not fully developed skeleton
  • Local tumor disease
  • Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy
  • Drug / drug or alcohol dependence

Sites / Locations

  • Uniklinikum DresdenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elastic spine pad

Rotaio

Arm Description

Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy.

Patients, who receive Rotaio (TM) as cervical disc prosthesis after ventral discectomy.

Outcomes

Primary Outcome Measures

Change in Neck disability index compared to baseline

Secondary Outcome Measures

Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline
Change in EuroQOL (EQ-5D) compared to baseline
Change in Core Outcome Measure Index (COMI) compared to baseline
Change in flexion and extension radiographs compared to baseline
Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline
Change in consumption of analgetics compared to baseline
The change in analgetics consumption will be assessed on a scale of increase - stable - reduction.
Return to work
Return to work
Return to work
Return to work
Return to work
Mortality
Mortality
Mortality
Mortality
Mortality
Adverse effects
Adverse effects
Adverse effects
Adverse effects
Adverse effects

Full Information

First Posted
October 13, 2016
Last Updated
October 14, 2016
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT02936739
Brief Title
Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

5. Study Description

Brief Summary
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Displacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elastic spine pad
Arm Type
Experimental
Arm Description
Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy.
Arm Title
Rotaio
Arm Type
Active Comparator
Arm Description
Patients, who receive Rotaio (TM) as cervical disc prosthesis after ventral discectomy.
Intervention Type
Device
Intervention Name(s)
Anterior cervical discectomy with prosthetic disc replacement / ESP.
Intervention Description
Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.
Intervention Type
Device
Intervention Name(s)
Anterior cervical discectomy with prosthetic disc replacement / Rotaio.
Intervention Description
Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement.
Primary Outcome Measure Information:
Title
Change in Neck disability index compared to baseline
Time Frame
6 weeks, 3, 6, 12 and 24 months postoperative
Secondary Outcome Measure Information:
Title
Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline
Time Frame
6 weeks, 3, 6, 12 and 24 months postoperative
Title
Change in EuroQOL (EQ-5D) compared to baseline
Time Frame
6 weeks, 3, 6, 12 and 24 months postoperative
Title
Change in Core Outcome Measure Index (COMI) compared to baseline
Time Frame
6 weeks, 3, 6, 12 and 24 months postoperative
Title
Change in flexion and extension radiographs compared to baseline
Time Frame
6 weeks, 3, 6 and 12 months postoperative
Title
Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline
Time Frame
6 weeks, 3, 6 and 12 months postoperative
Title
Change in consumption of analgetics compared to baseline
Description
The change in analgetics consumption will be assessed on a scale of increase - stable - reduction.
Time Frame
6 weeks, 3, 6, 12 and 24 months postoperative
Title
Return to work
Time Frame
6 weeks postoperative
Title
Return to work
Time Frame
3 months postoperative
Title
Return to work
Time Frame
6 months postoperative
Title
Return to work
Time Frame
12 months postoperative
Title
Return to work
Time Frame
24 months postoperative
Title
Mortality
Time Frame
6 weeks postoperative
Title
Mortality
Time Frame
3 months postoperative
Title
Mortality
Time Frame
6 months postoperative
Title
Mortality
Time Frame
12 months postoperative
Title
Mortality
Time Frame
24 months postoperative
Title
Adverse effects
Time Frame
6 weeks postoperative
Title
Adverse effects
Time Frame
3 months postoperative
Title
Adverse effects
Time Frame
6 months postoperative
Title
Adverse effects
Time Frame
12 months postoperative
Title
Adverse effects
Time Frame
24 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis Exclusion Criteria: Radiologic signs of extensive bone degeneration in the affected segment Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software Transversal spine cord lesion Cervical myelopathy Preceding surgery on the cervical spine Traumatic lesions of the cervical spine Radiographic instability in the affected segment: flexion / extension: shift sagittal plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation > 11º signs of instability (Olisthesis) in another segment of the cervical spine Active systemic infection diseases of the rheumatic type and all autoimmune diseases bone metabolic diseases (for example, Paget's disease) skeletal metastases infections in the cervical spine Neurological seizure disorders or other serious neurological disease with risk of falls Severe heart failure (NYHA III-IV) Bleeding disorders or clopidogrel / coumarins - treatment Systemic use of corticosteroids for more than a month in the last 12 months Pregnancy Legally incompetent patient Lactation Deformity, anomalies, not fully developed skeleton Local tumor disease Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy Drug / drug or alcohol dependence
Facility Information:
Facility Name
Uniklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Rieger, Dr.
Email
bernhard.rieger@uniklinikum-dresden.de

12. IPD Sharing Statement

Learn more about this trial

Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse

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