Clinical trial NCT01832818: 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
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Intervertebral Disc Degeneration
Keywords: Total Disc Replacement
Lead sponsor: Pioneer Surgical Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-16
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neck Disability Index (NDI) Score Improvement of at Least 15 Points
timeFrame: At 24 months
measure: Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
timeFrame: At 24 months
measure: Serious Adverse Events Related to the Device
timeFrame: Up to 24 months
measure: Device Failures or Removals, Revisions, Re-operations
timeFrame: Up to 24 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: At 24 months
measure: Absence of Device Migration or Subsidence
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Stockton-on-Tees
country: United Kingdom
facility: University Hospital of North Tees
Study officials:
affiliation: University Hospital of North Tees
name: Tai Friesem, MD
role: PRINCIPAL_INVESTIGATOR
References: