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Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion

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ClinicalTrials.gov Identifier: NCT01714804
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : December 20, 2017
Last Update Posted : January 23, 2018
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 lumbar spine fusion with a retrospective comparison to a historical patient cohort.

Condition or disease Intervention/treatment Phase
Stenosis Spondylosis Degenerative Changes Device: Accell Evo3 Prospective Use Not Applicable

Detailed Description:
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion in comparison to a retrospective cohort of Infuse subjects. Infuse subjects were not enrolled in the current study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Prospective
Accell Evo3
Device: Accell Evo3 Prospective Use



Primary Outcome Measures :
  1. Number of Levels With Posterolateral Fusion [ Time Frame: 12 months ]
    Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg) [ Time Frame: 12 months ]


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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:

  • Are 18 (eighteen) years of age or older at the time of surgery.
  • Require spinal fusion using TLIF, PLF or PLIF, with the use of an interbody spacer, at 1 to 3 levels between L3-S1.
  • 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 3 time points between 6 months and 24 months post-surgery (6±2 months, 12±3 months and 24±4 months post-surgery), including one CT-scan at 12±3 months.
  • Unresponsive to conservative care over a period of at least 6 months or has signs and/or symptoms that mandate urgent surgical intervention.

Exclusion Criteria:

  • Are long term users of medications (i.e. steroids greater than 2-weeks) 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. patients on inhaled steroids are allowed), or epidural steroid injections.
  • 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.
  • Are being treated with radiotherapy.
  • Are having medical conditions, known to impact bone metabolism, such as Paget's disease, osteoporosis.
  • Are smokers and/or nicotine/tobacco users.
  • Are pregnant, lactating or women wishing to become pregnant.
  • Are a prisoner.
  • Are currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
  • 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.
  • Use of any other bone graft or bone graft substitute in addition to or in place of Accell Evo3® with the exception of local autograft and/or cancellous bone chips.
  • 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).

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): NCT01714804


Locations
United States, Colorado
Spine Colorado
Durango, Colorado, United States, 81301
Sponsors and Collaborators
SeaSpine, Inc.
Investigators
Principal Investigator: Jim Youssef, MD Spine Colorado

Responsible Party: SeaSpine, Inc.
ClinicalTrials.gov Identifier: NCT01714804     History of Changes
Other Study ID Numbers: ACC3-US-2012-1
First Posted: October 26, 2012    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: January 23, 2018
Last Verified: December 2017

Keywords provided by SeaSpine, Inc.:
Bone Morphogenetic Protein (BMP)
Demineralized bone matrix (DBM)
Fusion rates
Interbody fusion
Lumbar spine
Transverse lumbar interbody fusion (TLIF)
Patient reported outcomes
Posterolateral lumbar fusion (PLF)

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