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Trial record 1 of 4 for:    seaspine
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Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02018445
First Posted: December 23, 2013
Last Update Posted: June 29, 2017
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.
Information provided by (Responsible Party):
SeaSpine, Inc.
  Purpose
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 Intervention
Degenerative Changes Stenosis Spondylosis Device: Accell Evo3 Demineralized Bone Matrix

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Integra Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion

Further study details as provided by SeaSpine, Inc.:

Primary Outcome Measures:
  • Time to arthrodesis (fusion) in the posterolateral space for the Accell Evo3, as measured by X-rays at 3, 6, 12 and 24 months [ Time Frame: up to 24 months ]

Secondary Outcome Measures:
  • Extent of posterolateral arthrodesis (fusion), as measured by CT [ Time Frame: 12 months ]
  • Interbody fusion as determined by X-ray, at 3, 6, 12 and 24 months [ Time Frame: upto 24 months ]
  • Interbody fusion as determined by CT [ Time Frame: 12 months ]
  • Medical Outcomes: Measure of Health Outcome EQ-5D™, at all available time-points. [ Time Frame: upto 24 months ]
  • Medical Outcomes: Oswestry Disability Index, all available time-points. [ Time Frame: upto 24 months ]
  • Medical Outcomes: Leg pain VAS at all available time-points. [ Time Frame: upto 24 months ]
  • Medical Outcomes: Back pain VAS, at all available time-points. [ Time Frame: upto 24 months ]
  • Medical Outcomes: Maintenance of lower extremity neurological function at all available time-points. [ Time Frame: upto 24 months ]
  • • Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions [ Time Frame: upto 24 months ]

Enrollment: 36
Study Start Date: November 2013
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accell Evo3 Demineralized Bone Matrix Device: Accell Evo3 Demineralized Bone Matrix

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
United States, California
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806
Sponsors and Collaborators
SeaSpine, Inc.
Investigators
Principal Investigator: Philip Yuan, M.D Memorial Orthopaedic Surgical Group
  More Information

Responsible Party: SeaSpine, Inc.
ClinicalTrials.gov Identifier: NCT02018445     History of Changes
Other Study ID Numbers: ACC3-US-2012-2
First Submitted: December 17, 2013
First Posted: December 23, 2013
Last Update Posted: June 29, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases