Investigation of the Simplify® Cervical Artificial Disc

NCT02667067 | Completed Results

• 1 other identifier: G140154
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 16

Brief Summary

This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.

Conditions

Cervical Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Composite Clinical Success (CCS) of Simplify Disc

  Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months. Individual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.

  Baseline, 24 Months

Secondary Outcomes (15)

• Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)

  Baseline, 3 Months

• VAS Neck and Arm Pain

  Baseline, 24 Months

• Neurological Status

  Baseline, 24 Months

• SF-12 Physical Component Score (PCS) Maintenance or Improvement

  Baseline, 24 Months

• SF-12 Mental Component Score (MCS) Maintenance or Improvement

  Baseline, 24 Months

Study Arms (2)

Anterior cervical discectomy & fusion (ACDF)

OTHER

Device: Anterior Cervical Discectomy & Fusion

Simplify Disc

EXPERIMENTAL

Simplify Disc

Device: Simplify Disc

Interventions

Simplify Disc DEVICE

Simplify Disc at one level in the cervical spine.

Simplify Disc

Anterior Cervical Discectomy & Fusion DEVICE

This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\|C Disc trial.

Also known as: ACDF

Anterior cervical discectomy & fusion (ACDF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 18 and 60 years of age;
• Have symptoms of cervical degenerative disc disease (DDD) at one cervical level from C3 to C7 defined as intractable radiculopathy (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space and radiographic evidence of at least one of the following;
• Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI or;
• Disc height decreased by ≥ 1 mm when compared to adjacent levels on radiographic film, CT, or MRI or
• Disc herniation on CT or MRI;
• Have at least one of the following radiculopathy or myelopathy symptoms in neck and/or arm;
• Pain or paresthesias in a specific nerve root distribution from C3 to C7,
• Decreased muscle strength of at least one level on the 0-5 scale, or
• Abnormal sensation, including hyperesthesia or hypoesthesia.
• Have at least one of the following:
• At least six weeks of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose);
• The presence of progressive symptoms (e.g., increasing numbness or tingling) or
• Signs of nerve root compression.
• Have a Neck Disability Index (NDI) greater than or equal to 40 on a scale of 100 (moderate disability);
• Be appropriate for treatment using an anterior surgical approach;

You may not qualify if:

• Marked cervical instability on resting lateral or flexion/ extension X-ray (translation \> 3 mm or \> 11 degrees rotation to that of either adjacent non-treatment level);
• Non discogenic neck pain or non discogenic source of symptoms (e.g., tumor, rotator cuff injury, etc.);
• Radiographic confirmation of severe facet disease or facet degeneration;
• Bridging osteophytes;
• Less than 2 degrees of motion at index level;
• Prior surgery at the level to be treated, except laminotomy without accompanying facetectomy;
• Prior fusion at any cervical level;
• More than one neck surgery via anterior approach;
• Previous trauma to the C3-C7 levels resulting in compression or bursting;
• Documented presence of a free nuclear fragment at cervical levels other than the study level;
• Axial neck pain only (no radicular or myelopathy symptoms);
• Symptomatic DDD at more than one cervical level;
• Severe myelopathy (less than 3/5 muscle strength);
• Any paralysis;
• Recent history (within previous six months) of chemical or alcohol dependence;

Sponsors & Collaborators

• NuVasive: lead

Study Sites (16)

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Thornton, Colorado, United States

Location

Unknown Facility

Sarasota, Florida, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Carmel, Indiana, United States

Location

Unknown Facility

Paducah, Kentucky, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Egg Harbor, New Jersey, United States

Location

Unknown Facility

Lockport, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Addison, Texas, United States

Location

Unknown Facility

Plano, Texas, United States

Location

Unknown Facility

Tyler, Texas, United States

Location

Unknown Facility

Reston, Virginia, United States

Location

Limitations and Caveats

ACDF data is presented as a historical control fusion group from the Kineflex®\|C Disc trial

Results Point of Contact

• Title: Nicole Czaplewski
• Organization: NuVasive, Inc.

nczaplewski@nuvasive.com

308-660-2021

Study Officials

• Kyle Malone

  NuVasive

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: January 28, 2016
• Study Start: November 1, 2015
• Primary Completion: March 23, 2020
• Study Completion: July 29, 2021
• Last Updated: January 8, 2026
• Results First Posted: June 6, 2022

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)