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

NCT01714804 | Completed Results

• 1 other identifier: ACC3-US-2012-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Number of Levels With Posterolateral Fusion

  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

  12 months

Secondary Outcomes (1)

• Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)

  12 months

Study Arms (1)

Prospective

EXPERIMENTAL

Accell Evo3

Device: Accell Evo3 Prospective Use

Interventions

Accell Evo3 Prospective Use DEVICE

Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SeaSpine, Inc.: lead

Study Sites (1)

Spine Colorado

Durango, Colorado, 81301, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic; Spondylosis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Vice President, Orthobiologics Research & Development
• Organization: SeaSpine

frank.vizesi@seaspine.com

760.216.5138

Study Officials

• Jim Youssef, MD

  Spine Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 26, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 23, 2018
• Results First Posted: December 20, 2017

Record last verified: 2017-12

Locations

US (1)