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

A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Intervertebral Disc Degeneration
• Intervention / Treatment: Device: NuNec Cervical Disc

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Stockton-on-Tees, United Kingdom
    • University Hospital of North Tees

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NuNec Cervical Disc; 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.	Device: NuNec Cervical Disc; Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.; Other Names: NuNec Cervical Arthroplasty System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 24 months
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.	At 24 months
Serious Adverse Events Related to the Device	The number of serious adverse events have been recorded	Up to 24 months
Device Failures or Removals, Revisions, Re-operations	The failures or re-operations or supplemental fixation at the treated level	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	As assessed on patient questionnaire.	At 24 months
Absence of Device Migration or Subsidence	Absence of device migration > 3mm; Absence of device subsidence > 3mm	Up to 24 months

Collaborators and Investigators

• Sponsor: Pioneer Surgical Technology, Inc.
• Investigators: Principal Investigator: Tai Friesem, MD, University Hospital of North Tees

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (ESTIMATE): April 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Total Disc Replacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: C01 (Other Identifier: CSWOG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED