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.

Tracking Information

• First Submitted Date: October 8, 2015
• First Posted Date: January 28, 2016
• Last Update Posted Date: June 18, 2020
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2017)

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.

Original Primary Outcome Measures (submitted: January 25, 2016)

Composite clinical success (CCS) rate of the Simplify® Disc [ Time Frame: 24 Months ]

The Month 24 composite clinical success (CCS) rate of the Simplify™ Disc will be no worse than conventional ACDF when success of ACDF is evaluated at Month 24. Individual success for the investigational Simplify™ Disc 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 of index procedure; and the absence of major adverse events within 24 months. Individual success for the control ACDF device 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 with 24 months; and the absence of major adverse events within 24 months

Current Secondary Outcome Measures (submitted: April 3, 2017)

• 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.
• Time to Recovery [ Time Frame: Baseline, 3, 12, 24, 36, 48 and 60 Months ]
  Time to first 15-point NDI improvement
• 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.
• 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.
• Radiographic Assessments [ Time Frame: Baseline or Post-Op, 3, 12, 24, 36, 48 and 60 Months ]

Original Secondary Outcome Measures (submitted: January 25, 2016)

• 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.
• Disc Height [ Time Frame: 24 Months ]
  Compared baseline for the investigational Simplify® Disc and at 24 months compared to baseline for the control ACDF, as measured by standard lateral radiograph (spot film, distance of 6 feet, centered at C5 with patient upright).
• Time to Recovery [ Time Frame: Baseline, 3, 12, 24, 36, 48 and 60 Months ]
  Time to first 15-point NDI improvement
• Adjacent Level of Deterioration, radiograph [ Time Frame: 24 Months ]
  Compared to baseline for the investigational Simplify® Disc and at 24 months compared to baseline for the control ACDF.
• Displacement or migration of the device [ Time Frame: Baseline, 3, 12, 24, 36, 48 and 60 Months ]
  Only changes of > 3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.
• Treatment Satisfaction, patient questionnaire [ Time Frame: 12 months and 24 Months ]
  12 months investigational Simplify® Disc compared to 24 months for the control ACDF.
• Health Survey, SF-12v2 patient questionnaire [ Time Frame: Baseline, 12 Months and 24 Months ]
  12 months investigational Simplify® Disc compared to 24 months for the control ACDF.
• Dysphagia Handicap Index, DHI scale [ Time Frame: 24 Months ]
  Compared to baseline.
• Facet deterioration, radiograph [ Time Frame: 24 Months ]
  Compared to baseline.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of the Simplify® Cervical Artificial Disc
• Official Title: Clinical Study Protocol for the Investigation Of The Simplify® Cervical Artificial Disc
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cervical Degenerative Disc Disease

Intervention

• Device: Simplify Disc
  Simplify Disc at one level in the cervical spine.
• 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

Study Arms

• Ant cervical discectomy & fusion (ACDF)
  Intervention: Device: Anterior Cervical Discectomy & Fusion
• Experimental: Simplify Disc
  Simplify Disc
  Intervention: Device: Simplify Disc

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 25, 2016): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2023
• Actual Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02667067
• Other Study ID Numbers: G140154
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Simplify Medical Inc.
• Study Sponsor: Simplify Medical Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Simplify Medical Inc.
• Verification Date: June 2020