Clinical trial NCT02018445: Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Changes
Stenosis
Spondylosis
Lead sponsor: SeaSpine, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.
timeFrame: 12 months
Secondary outcomes:
measure: Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan
timeFrame: 12 months
measure: Medical Outcomes: Oswestry Disability Index (ODI)
timeFrame: 12 months
measure: Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS)
timeFrame: 12 months
measure: Medical Outcomes: Back Pain Visual Analog Scale (VAS)
timeFrame: 12 months
measure: Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS).
timeFrame: 12 months
measure: Medical Outcomes: Maintenance of Lower Extremity Neurological Function
timeFrame: 12 months
measure: Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions
timeFrame: 24 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
Study officials:
affiliation: Memorial Orthopaedic Surgical Group
name: Philip Yuan, M.D
role: PRINCIPAL_INVESTIGATOR
References: