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Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion

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: NCT02018445
Recruitment Status : Completed
First Posted : December 23, 2013
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
SeaSpine, Inc.

Brief Summary:
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.

Condition or disease Intervention/treatment Phase
Degenerative Changes Stenosis Spondylosis Procedure: Posterolateral Fusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : November 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Accell Evo3 DBM & Local Autograft
Accell Evo3 DBM (posterolateral gutter symptomatic side) and Local Autograft (posterolateral gutter contralateral non-symptomatic side)
Procedure: Posterolateral Fusion



Primary Outcome Measures :
  1. Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays. [ Time Frame: 12 months ]
    There were 29 patients and 43 total spinal levels (unit) treated at baseline. Time to arthodesis was measured as the mean time to achieve fusion. At each time point fusion was evaluated, the first time point fusion was achieved was considered fusion.


Secondary Outcome Measures :
  1. Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan [ Time Frame: 12 months ]
  2. Medical Outcomes: Oswestry Disability Index (ODI) [ Time Frame: 12 months ]
    The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.

  3. Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS) [ Time Frame: 12 months ]
    The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the worst leg pain. A lower score represents a better score.

  4. Medical Outcomes: Back Pain Visual Analog Scale (VAS) [ Time Frame: 12 months ]
    The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100- mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the back pain. A lower score represents a better score.

  5. Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS). [ Time Frame: 12 months ]
    EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Only the EQ VAS Score was analyzed in the study. The EQ VAS scored from 0-100 and a lower score represents a better score.

  6. Medical Outcomes: Maintenance of Lower Extremity Neurological Function [ Time Frame: 12 months ]

    Posterolateral fusion study in which one spinal level is treated with both the study and control arm. One posterolateral spinal side is Evo3 and the other posterolateral spinal side is local autograft.

    NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between left and right side neurological function. Neurological function is indistinguishable between the right and left side of the lower extremities using the methods in the protocol and analysis of neurological function therefore would have made no impact on the outcome of the study.


  7. Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are 18 (eighteen) years of age or older at the time of surgery.
  2. Require spinal fusion using Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Fusion (PLF) or Posterior Lumbar Interbody Fusion (PLIF), with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1.
  3. Willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 4 time points between 2 weeks and 12 months post-surgery (3 months ± 2 weeks, 6±1 months, 12±2 months and if required 24±3 months post-surgery), including one CT-scan at 12±2 months.
  4. Unresponsive to conservative care over a period of at least 6 months or has signs and/or symptoms that mandate urgent surgical intervention.
  5. Willing and able to sign study specific informed consent.

Exclusion Criteria:

  1. Are long term users of medications (i.e. steroids greater than 8 days) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. subjects on inhaled steroids are allowed), or epidural steroid injections.
  2. Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery.
  3. Are being treated with radiotherapy.
  4. Are having medical conditions, known to impact bone metabolism, such as Paget's disease, osteoporosis, severe degenerative bone disease.
  5. Are smokers and/or nicotine/tobacco users.
  6. Have a Body Mass Index (BMI) ≥ 40
  7. Are pregnant, lactating or women wishing to become pregnant.
  8. Are a prisoner.
  9. Are currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
  10. Prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures.
  11. Use of any other bone graft or bone graft substitute in addition to or in place of Accell Evo3 and/or local autograft.
  12. Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).
  13. Have a known sensitivity Polymyxin Sulfate B, Bacitracin, Gentamycin and/or Iodine.
  14. Severe vascular or neurological disease.
  15. Uncontrolled diabetes.
  16. Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol.
  17. Renal impairment.
  18. Active or latent infection in or around the surgical site.
  19. Accell Evo3 is contraindicated when there is significant vascular impairment proximal to the implantation site and when there are metabolic or systemic bone disorders that affect bone or wound healing, or when stabilization of the defect is not possible.
  20. The use of Accell Evo3 is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible and in infected or contaminated wounds.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018445


Locations
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United States, California
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806
Sponsors and Collaborators
SeaSpine, Inc.
Investigators
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Principal Investigator: Philip Yuan, M.D Memorial Orthopaedic Surgical Group
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Responsible Party: SeaSpine, Inc.
ClinicalTrials.gov Identifier: NCT02018445    
Other Study ID Numbers: ACC3-US-2012-2
First Posted: December 23, 2013    Key Record Dates
Results First Posted: February 18, 2020
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases