Investigation of the Two Level Simplify® Cervical Artificial Disc

NCT03123549 | Completed Results FDA Device

• 1 other identifier: G150206
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 18

Brief Summary

This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management.

Conditions

Cervical Degenerative Disc Disorder

Outcome Measures

Primary Outcomes (1)

• Composite Clinical Success (CCS) Rate of the Simplify® Disc

  Individual success 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 additional surgical procedure at the index level within 24 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated 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.

  24 Months

Secondary Outcomes (15)

• Neurological Status

  Baseline, 24mos

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

  Baseline, 3mos

• Neck Pain Intensity Questionnaire

  Baseline, 24mos.

• Arm Pain Intensity Questionnaire

  Baseline, 24mos.

• Patient Questionnaires- Treatment Satisfaction Survey

  Baseline, 24mos.

Study Arms (2)

Simplify Disc

EXPERIMENTAL

Simplify Disc at two levels of the cervical spine

Device: Simplify Disc

Historical Control

NO INTERVENTION

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 of a previously completed two level cervical disc trial.

Interventions

Simplify Disc DEVICE

Simplify Disc at two levels of the cervical spine

Simplify Disc

Eligibility Criteria

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

You may qualify if:

• Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy, or both;
• Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck pain with arm pain, functional deficit and/or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
• Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management;
• Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s);
• Must be at least 18 years of age and be skeletally mature at the time of surgery;
• Has a preoperative Neck Disability Index (NDI) ≥ 30;
• Has a preoperative neck pain score \> 8 based on the preoperative Neck and Arm Pain Questionnaire;
• If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;
• Is willing to comply with the study plan and sign the Patient Informed Consent Form.

You may not qualify if:

• Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
• Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
• Sagittal plane translation \> 3.5 mm, or
• Sagittal plane angulation \> 20°;
• Has more than two cervical levels requiring surgical treatment;
• Has a fused level (or artificial disc replacement) adjacent to the levels to be treated;
• Has severe pathology of the facet joints of the involved vertebral bodies;
• Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels;
• Axial neck pain only (no radicular or myelopathy symptoms);
• Has been previously diagnosed with osteopenia or osteomalacia;
• Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility):
• Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds;
• Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture;
• Male over the age of 70;
• Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.

Sponsors & Collaborators

• NuVasive: lead

Study Sites (18)

Orthopaedic Education and Research Institute of Southern California

Orange, California, 92868, United States

Location

The Spine Institute for Spine Restoration

Santa Monica, California, 90403, United States

Location

Spine Education and Research Foundation

Thornton, Colorado, 80229, United States

Location

Connecticut Orthopaedic Specialists

Hamden, Connecticut, 06518, United States

Location

Kennedy-White orthopedic Center

Sarasota, Florida, 34232, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42003, United States

Location

Spine institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Buffalo Spine Surgery

Lockport, New York, 14094, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Oregon Neurosurgery

Springfield, Oregon, 97477, United States

Location

Texas Spine Consultants

Addison, Texas, 75001, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

The Disc Replacement Center

West Jordan, Utah, 84088, United States

Location

Virginia Spine Institute

Reston, Virginia, 20191, United States

Location

Related Links

• Simplify Medical Website for the Simplify Disc Trial

Limitations and Caveats

ACDF data is presented as a historical control fusion group from a previously completed IDE trial.

Results Point of Contact

• Title: Jessica Fulwider
• Organization: NuVasive, Inc.

jfulwider@nuvasive.com

7037721455

Study Officials

• Kyle Malone

  NuVasive

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 21, 2017
• Study Start: April 1, 2017
• Primary Completion: November 12, 2020
• Study Completion: March 24, 2022
• Last Updated: January 8, 2026
• Results First Posted: January 6, 2023

Record last verified: 2025-12

Locations

US (18)