Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion

SeaSpine

Status

Completed

Conditions

Degenerative Changes

Spondylosis

Stenosis

Treatments

Procedure: Posterolateral Fusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT02018445

ACC3-US-2012-2

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are 18 (eighteen) years of age or older at the time of surgery.
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.
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.
Unresponsive to conservative care over a period of at least 6 months or has signs and/or symptoms that mandate urgent surgical intervention.
Willing and able to sign study specific informed consent.

Exclusion criteria

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.
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, severe degenerative bone disease.
Are smokers and/or nicotine/tobacco users.
Have a Body Mass Index (BMI) ≥ 40
Are pregnant, lactating or women wishing to become pregnant.
Are a prisoner.
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.
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 and/or local autograft.
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).
Have a known sensitivity Polymyxin Sulfate B, Bacitracin, Gentamycin and/or Iodine.
Severe vascular or neurological disease.
Uncontrolled diabetes.
Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol.
Renal impairment.
Active or latent infection in or around the surgical site.
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.
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.