Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of the Two Level Simplify® Cervical Artificial Disc

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123549
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Simplify Medical Inc.

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date March 16, 2021
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date November 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
Composite clinical success (CCS) rate of the Simplify® Disc [ Time Frame: 24 Months ]
Individual success is assessed by reviewing improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, and review of any additional index level surgeries and serious adverse events classified as implant associated or implant/surgical procedure associated within 24 months of index procedure.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
Composite clinical success (CCS) rate of the Simplify® Disc [ Time Frame: 24 Months ]
Individual success for both the investigational and control groups is assessed by reviewing improvement in NDI Score and neurological status at 24 months compared with baseline, maintenance or improvement in 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • Radicular Symptoms or Myelopathy [ Time Frame: Baseline, 6 wks., 3mos., 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Clinically significant improvement in one or more radicular symptoms or myelopathy
  • Radiographic Assessments [ Time Frame: Baseline, 6 wks., 3mos., 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Radiographic imaging to assess treatment status.
  • Time to Recovery [ Time Frame: Baseline, 6 wks., 3mos., 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Time to first 15-point NDI improvement
  • Neck and Arm Pain [ Time Frame: Baseline, 6 wks., 3mos., 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Assessment by the patient of their post-operative neck and arm pain according to the using a questionnaire.
  • Treatment Satisfaction [ Time Frame: Baseline, 6 wks., 3mos., 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Assessment by the patient of their treatment satisfaction using a questionnaire.
  • SF-36v2 Health Survey [ Time Frame: Baseline, 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Assessment of post-operative health status according to the patient using the SF36v2 questionnaire.
  • Dysphagia Handicap Index (DHI) [ Time Frame: Baseline, 6 wks., 3mos., 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Assessment of post-operative status according to the patient using the DHI.
  • Physician's Perception of Results [ Time Frame: Baseline, 6 wks., 3mos., 6mos., 12mos., 24mos., 36mos., 48 mos. and 60 mos. ]
    Assessment of post-operative status according to the treatment physician.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • Radicular Symptoms or Myelopathy [ Time Frame: 24 Month ]
    Clinically significant improvement in one or more radicular symptoms or myelopathy
  • Time to Recovery [ Time Frame: Baseline, 3, 12, 24, 36, 48 and 60 Months ]
    Time to first 15-point NDI improvement
  • Neck and arm pain VAS [ Time Frame: 12 and 24 Months ]
    Assessment of post-operative status according to VAS scale
  • Treatment Satisfaction Health Survey SF-12v2 [ Time Frame: 12 and 24 Months ]
    Assessment of post-operative status according to the subject
  • Dysphagia Handicap Index [ Time Frame: 12 and 24 Months ]
    Assessment of post-operative status according to Dysphagia Handicap Index
  • Odom's Criteria Results [ Time Frame: 12 and 24 Months ]
    Assessment of post-operative status 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  ICMJE Investigation of the Two Level Simplify® Cervical Artificial Disc
Official Title  ICMJE Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc
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.
Detailed Description The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Simplify® Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of 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 that are unresponsive to conservative management.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Degenerative Disc Disorder
Intervention  ICMJE Device: Simplify Disc
Simplify Disc at two levels of the cervical spine
Study Arms  ICMJE
  • Experimental: Simplify Disc
    Simplify Disc at two levels of the cervical spine
    Intervention: Device: Simplify Disc
  • No Intervention: Historical Control
    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=188) of a previously completed two level cervical disc trial.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2017)
200
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
300
Estimated Study Completion Date  ICMJE August 2021
Actual Primary Completion Date November 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
    • If the level of bone mineral density is a T score of -1.5 or lower (i.e., -1.6, 1.7, etc.), then the patient is excluded from the study
  • Has presence of spinal metastases;
  • Has overt or active bacterial infection, either local or systemic;
  • Has insulin-dependent diabetes;
  • Has chronic or acute renal failure or prior history of renal disease;
  • Known PEEK, ceramic, titanium allergy;
  • Is mentally incompetent (if questionable, obtain psychiatric consult);
  • Is a prisoner;
  • Is pregnant;
  • Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;
  • Is involved with current or pending litigation regarding a spinal condition;
  • Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;
  • Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
  • Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs);
  • Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03123549
Other Study ID Numbers  ICMJE G150206
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Simplify Medical Inc.
Study Sponsor  ICMJE Simplify Medical Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Simplify Medical Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP