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

NCT ID: NCT01832818

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-01-31

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.

Conditions

Cervical Intervertebral Disc Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NuNec Cervical Disc

Intervention Type: DEVICE

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

Interventions

NuNec Cervical Disc

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

Intervention Type: DEVICE

Other Intervention Names

NuNec Cervical Arthroplasty System

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pioneer Surgical Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tai Friesem, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Tees

Locations

University Hospital of North Tees

Stockton-on-Tees, , United Kingdom

Countries

United Kingdom

Other Identifiers

C01

Identifier Type: -

Identifier Source: org_study_id