Investigation of the Simplify® Cervical Artificial Disc

• ClinicalTrials.gov Identifier: NCT02667067
• Recruitment Status: Active, not recruiting
• First Posted: January 28, 2016
• Last Update Posted: June 18, 2020
• Sponsor: Simplify Medical Inc.
• Information provided by (Responsible Party): Simplify Medical Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Degenerative Disc Disease	Device: Simplify Disc; Device: Anterior Cervical Discectomy & Fusion	Not Applicable

Detailed Description:

The objective of this clinical study is to evaluate the safety and effectiveness of the Simplify® Disc for treatment of DDD compared to conventional ACDF for reconstruction of the disc space at one level between C3 to C7 for 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 that is unresponsive to conservative management.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study Protocol for the Investigation Of The Simplify® Cervical Artificial Disc
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: March 2020
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
Ant cervical discectomy & fusion (ACDF)	Device: Anterior Cervical Discectomy & Fusion; 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.; Other Name: ACDF
Experimental: Simplify Disc; Simplify Disc	Device: Simplify Disc; Simplify Disc at one level in the cervical spine.

Outcome Measures

Primary Outcome Measures :

1. Composite clinical success (CCS) rate of the Simplify® Disc [ Time Frame: 24 Months ]
   Individual success for the investigational Simplify® Disc and control ACDF device is assessed by reviewing NDI score and neurologic status at 24 months compared with baseline and review of any additional index level surgeries and major adverse events within 24 months of index procedure.

Secondary Outcome Measures :

1. Radicular Symptoms or Myelopathy [ Time Frame: Baseline, 12 Months, 24 Months ]
   Clinically significant improvement in one or more radicular symptoms or myelopathy at 12 months compared to baseline for the investigational Simplify™ Disc and 24 months compared to baseline for the control ACDF.
2. Time to Recovery [ Time Frame: Baseline, 3, 12, 24, 36, 48 and 60 Months ]
   Time to first 15-point NDI improvement
3. Patient Questionnaires- Neck and arm pain VAS, Treatment Satisfaction Health Survey, SF-12v2, Dysphagia Handicap Index [ Time Frame: 12 months and/or 24 Months ]
   12 months investigational Simplify® Disc compared to 24 months for the control ACDF.
4. Odom's Criteria Results [ Time Frame: 12 Month and 24 Months ]
   Results at 12 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.
5. Radiographic Assessments [ Time Frame: Baseline or Post-Op, 3, 12, 24, 36, 48 and 60 Months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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;

  1. Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI or;
  2. Disc height decreased by ≥ 1 mm when compared to adjacent levels on radiographic film, CT, or MRI or
  3. Disc herniation on CT or MRI;

• Have at least one of the following radiculopathy or myelopathy symptoms in neck and/or arm;

  1. Pain or paresthesias in a specific nerve root distribution from C3 to C7,
  2. Decreased muscle strength of at least one level on the 0-5 scale, or
  3. Abnormal sensation, including hyperesthesia or hypoesthesia.

• Have at least one of the following:

  1. 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);
  2. The presence of progressive symptoms (e.g., increasing numbness or tingling) or
  3. 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;
• Be likely to return for all follow-up visits and
• Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria:

• 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;
• Active systemic infection;
• Infection at the site of surgery;
• Prior disc space infection or osteomyelitis in the cervical spine;
• Any terminal, systemic or autoimmune disease;
• Metabolic bone disease (e.g., osteoporosis/osteopenia , gout, osteomalacia, Paget's disease);

• Any disease, condition or surgery which might impair healing, such as;

  1. Diabetes mellitus requiring daily insulin management,
  2. Active malignancy,
  3. History of metastatic malignancy.
• Current or extended use (> 6 months) of any drug known to interfere with bone or soft tissue healing;
• Known PEEK, ceramic, titanium allergy;
• Arachnoiditis;
• Significant cervical anatomical deformity at the index level or clinically compromised cervical vertebral bodies at the index level due to current or past trauma (e.g., by radiographic appearance of fracture callus, malunion, or nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis);
• Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin;
• Pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery ;
• Use of spinal stimulator at any cervical level prior to surgery;
• Currently a prisoner;
• Currently involved in spinal litigation which may influence the subjects reporting of symptoms or
• Participation in any other investigational drug, biologic or medical device study within the last 30 days prior to study surgery.

Contacts and Locations

Locations

United States, California

La Jolla, California, United States

Orange, California, United States

Santa Monica, California, United States

United States, Colorado

Thornton, Colorado, United States

United States, Florida

Sarasota, Florida, United States

United States, Illinois

Evanston, Illinois, United States

United States, Indiana

Carmel, Indiana, United States

United States, Kentucky

Paducah, Kentucky, United States

United States, Louisiana

Shreveport, Louisiana, United States

United States, New Jersey

Egg Harbor Township, New Jersey, United States

United States, New York

Lockport, New York, United States

United States, North Carolina

Charlotte, North Carolina, United States

United States, Texas

Addison, Texas, United States

Plano, Texas, United States

Tyler, Texas, United States

United States, Virginia

Reston, Virginia, United States

Sponsors and Collaborators

Simplify Medical Inc.

More Information

• Responsible Party: Simplify Medical Inc.
• ClinicalTrials.gov Identifier: NCT02667067
• Other Study ID Numbers: G140154
• First Posted: January 28, 2016
• Last Update Posted: June 18, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases