Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion

NCT02018445 | Completed Results

• 1 other identifier: ACC3-US-2012-2
• Study Type: interventional
• Target: 36
• 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 posterolateral spine fusion, as compared to local autograft.

Conditions

Degenerative Changes; Stenosis; Spondylosis

Outcome Measures

Primary Outcomes (1)

• Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.

  There were 29 patients and 43 total spinal levels (unit) treated at baseline. Time to arthodesis was measured as the mean time to achieve fusion. At each time point fusion was evaluated, the first time point fusion was achieved was considered fusion.

  12 months

Secondary Outcomes (7)

• Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan

  12 months

• Medical Outcomes: Oswestry Disability Index (ODI)

  12 months

• Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS)

  12 months

• Medical Outcomes: Back Pain Visual Analog Scale (VAS)

  12 months

• Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS).

  12 months

Study Arms (1)

Accell Evo3 DBM & Local Autograft

OTHER

Accell Evo3 DBM (posterolateral gutter symptomatic side) and Local Autograft (posterolateral gutter contralateral non-symptomatic side)

Procedure: Posterolateral Fusion

Interventions

Posterolateral Fusion PROCEDURE

Accell Evo3 DBM & Local Autograft

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SeaSpine, Inc.: lead

Study Sites (1)

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, 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: Sara Tish Mikoczi
• Organization: SeaSpine

tish.mikoczi@seaspine.com

760-216-5652

Study Officials

• Philip Yuan, M.D

  Memorial Orthopaedic Surgical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: May 1, 2017
• Last Updated: February 18, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-02

Locations

US (1)