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

NCT01832818 | Terminated Results

• 1 other identifier: C01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intervertebral Disc Degeneration

Keywords

Total Disc Replacement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Patient Satisfaction

  At 24 months

• Absence of Device Migration or Subsidence

  Up to 24 months

Study Arms (1)

NuNec Cervical Disc

EXPERIMENTAL

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

Interventions

NuNec Cervical Disc DEVICE

Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.

Also known as: NuNec Cervical Arthroplasty System

NuNec Cervical Disc

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pioneer Surgical Technology, Inc.: lead

Study Sites (1)

University Hospital of North Tees

Stockton-on-Tees, United Kingdom

Location

Results Point of Contact

• Title: Robin Waite
• Organization: RTI Surgical

rwaite@rtix.com

386-418-8888

Study Officials

• Tai Friesem, MD

  University Hospital of North Tees

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 16, 2013
• Study Start: March 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-10

Locations

GB (1)