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

Cervical Intervertebral Disc Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01832818
• Other study ID #: C01
• Status: Terminated
• Phase: N/A
• Start date: March 2012
• Est. completion date: January 2016

Study information

• Verified date: October 2018
• Source: Pioneer Surgical Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intervertebral Disc Degeneration
• Intervertebral Disc Degeneration

Intervention

Device:
• NuNec Cervical Disc
Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.

Locations

Country	Name	City	State
United Kingdom	University Hospital of North Tees	Stockton-on-Tees

Sponsors (1)

Lead Sponsor	Collaborator
Pioneer Surgical Technology, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Serious Adverse Events Related to the Device	The number of serious adverse events have been recorded	Up to 24 months
Primary	Device Failures or Removals, Revisions, Re-operations	The failures or re-operations or supplemental fixation at the treated level	Up to 24 months
Secondary	Patient Satisfaction	As assessed on patient questionnaire.	At 24 months
Secondary	Absence of Device Migration or Subsidence	Absence of device migration > 3mm; Absence of device subsidence > 3mm	Up to 24 months