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Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

Primary Purpose

Cervical Intervertebral Disc Degeneration

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NuNec Cervical Disc
Sponsored by
Pioneer Surgical Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intervertebral Disc Degeneration focused on measuring Total Disc Replacement

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • is at least 21 years of age and skeletally mature
  • must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis;
  • must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
  • must score at least 15/50 (30%) on the Neck Disability Index
  • is willing and able to follow the post-operative management program
  • must understand and sign the informed consent document

Exclusion Criteria:

  • symptomatic cervical DDD at more than one level
  • axial neck pain as the primary diagnosis without evidence of neural compression
  • neck or arm pain of unknown etiology
  • any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible
  • severe spondylosis at the target level
  • prior surgery at the target level
  • fused level adjacent to the target level
  • osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
  • active infection or surgical site infection
  • is using any medication known to interfere with bone/soft tissue healing
  • diabetes mellitus requiring daily insulin management
  • any terminal, systemic, or autoimmune disease
  • medical conditions or mental incompetence which may interfere with study requirements
  • BMI >40 or a weight more than 100 lbs over ideal body weight
  • chemical dependency problem that may interfere with study requirements
  • current smokers
  • history of any invasive malignancy unless treated and in remission for at least two years
  • documented allergies to metal or plastic
  • currently pregnant, or interested in becoming pregnant during the study follow-up

Sites / Locations

  • University Hospital of North Tees

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NuNec Cervical Disc

Arm Description

Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.

Outcomes

Primary Outcome Measures

Neck Disability Index (NDI) Score Improvement of at Least 15 Points
The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score would indicate that the patient had a worse outcome.
Serious Adverse Events Related to the Device
The number of serious adverse events have been recorded
Device Failures or Removals, Revisions, Re-operations
The failures or re-operations or supplemental fixation at the treated level

Secondary Outcome Measures

Patient Satisfaction
As assessed on patient questionnaire.
Absence of Device Migration or Subsidence
Absence of device migration > 3mm; Absence of device subsidence > 3mm

Full Information

First Posted
April 10, 2013
Last Updated
October 1, 2018
Sponsor
Pioneer Surgical Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01832818
Brief Title
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Official Title
A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
This study has been terminated early due to slow enrolment.
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pioneer Surgical Technology, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
Detailed Description
The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled. Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intervertebral Disc Degeneration
Keywords
Total Disc Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NuNec Cervical Disc
Arm Type
Experimental
Arm Description
Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.
Intervention Type
Device
Intervention Name(s)
NuNec Cervical Disc
Other Intervention Name(s)
NuNec Cervical Arthroplasty System
Intervention Description
Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI) Score Improvement of at Least 15 Points
Description
The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.
Time Frame
At 24 months
Title
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
Description
The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score would indicate that the patient had a worse outcome.
Time Frame
At 24 months
Title
Serious Adverse Events Related to the Device
Description
The number of serious adverse events have been recorded
Time Frame
Up to 24 months
Title
Device Failures or Removals, Revisions, Re-operations
Description
The failures or re-operations or supplemental fixation at the treated level
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
As assessed on patient questionnaire.
Time Frame
At 24 months
Title
Absence of Device Migration or Subsidence
Description
Absence of device migration > 3mm; Absence of device subsidence > 3mm
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: is at least 21 years of age and skeletally mature must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis; must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment must score at least 15/50 (30%) on the Neck Disability Index is willing and able to follow the post-operative management program must understand and sign the informed consent document Exclusion Criteria: symptomatic cervical DDD at more than one level axial neck pain as the primary diagnosis without evidence of neural compression neck or arm pain of unknown etiology any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible severe spondylosis at the target level prior surgery at the target level fused level adjacent to the target level osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease active infection or surgical site infection is using any medication known to interfere with bone/soft tissue healing diabetes mellitus requiring daily insulin management any terminal, systemic, or autoimmune disease medical conditions or mental incompetence which may interfere with study requirements BMI >40 or a weight more than 100 lbs over ideal body weight chemical dependency problem that may interfere with study requirements current smokers history of any invasive malignancy unless treated and in remission for at least two years documented allergies to metal or plastic currently pregnant, or interested in becoming pregnant during the study follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tai Friesem, MD
Organizational Affiliation
University Hospital of North Tees
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Tees
City
Stockton-on-Tees
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

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