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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01714804
First received: October 22, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Stenosis
Spondylosis
Degenerative Changes
Device: Accell Evo3 Prospective Use

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion

Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Posterolateral fusion by radiographic assessment at 12 months post surgery. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes at 12 months post-surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posterolateral fusion by radiographic assessment at 6 and 24 months post surgery [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
  • Interbody fusion by radiographic assessment at 6, 12, and 24 months post surgery [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes at 6 and 24 months post-surgery [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prospective
Accell Evo3
Device: Accell Evo3 Prospective Use

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714804

Locations
United States, Colorado
Spine Colorado
Durango, Colorado, United States, 81301
Sponsors and Collaborators
Integra LifeSciences Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01714804     History of Changes
Other Study ID Numbers: ACC3-US-2012-1
Study First Received: October 22, 2012
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014