Clinical trial NCT01714804: Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
Official title: Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis
Spondylosis
Degenerative Changes
Keywords: 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)
Lead sponsor: SeaSpine, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Number of Levels With Posterolateral Fusion
timeFrame: 12 months
Secondary outcomes:
measure: Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)
timeFrame: 12 months
Other outcomes:
Locations:
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
Study officials:
affiliation: Spine Colorado
name: Jim Youssef, MD
role: PRINCIPAL_INVESTIGATOR
References: