Degenerative ChangesNCT02018445
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
A study testing Posterolateral Fusion in people with Degenerative Changes and Stenosis, run by SeaSpine, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Changes, Stenosis, Spondylosis
- What is being tested?
- Posterolateral Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
About this study
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
- Being tested
- Posterolateral Fusion
- Medical subject headings
- Constriction, Pathologic, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterolateral FusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Accell Evo3 DBM & Local Autograft | Other | Accell Evo3 DBM (posterolateral gutter symptomatic side) and Local Autograft (posterolateral gutter contralateral non-symptomatic side) Receives: Procedure: Posterolateral Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan
Measured: 12 months
Medical Outcomes: Oswestry Disability Index (ODI)
The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.
Measured: 12 months
Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS)
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the worst leg pain. A lower score represents a better score.
Measured: 12 months
Medical Outcomes: Back Pain Visual Analog Scale (VAS)
The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100- mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the back pain. A lower score represents a better score.
Measured: 12 months
Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS).
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Only the EQ VAS Score was analyzed in the study. The EQ VAS scored from 0-100 and a lower score represents a better score.
Measured: 12 months
Medical Outcomes: Maintenance of Lower Extremity Neurological Function
Posterolateral fusion study in which one spinal level is treated with both the study and control arm. One posterolateral spinal side is Evo3 and the other posterolateral spinal side is local autograft.
NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between left and right side neurological function. Neurological function is indistinguishable between the right and left side of the lower extremities using the methods in the protocol and analysis of neurological function therefore would have made no impact on the outcome of the study.
Measured: 12 months
Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaSpine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Yuan, M.D, Principal investigator, Memorial Orthopaedic Surgical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018445
- Sponsor's protocol ID
- ACC3-US-2012-2
- Status last verified
- Feb 2020
- First submitted
- 17 Dec 2013
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
- ClinicalTrials.gov ID
- NCT02018445
- Acronym / sponsor ID
- ACC3-US-2012-2
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SeaSpine, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accell Evo3 DBM & Local Autograft | Other | Procedure: Posterolateral FusionAccell Evo3 DBM (posterolateral gutter symptomatic side) and Local Autograft (posterolateral gutter contralateral non-symptomatic side) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterolateral Fusion | Procedure or surgery | Accell Evo3 DBM & Local Autograft |
Primary outcome
Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.
Time frame: 12 months
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.
7 secondary outcomes
Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan
Time frame: 12 months
Medical Outcomes: Oswestry Disability Index (ODI)
Time frame: 12 months
Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS)
Time frame: 12 months
Medical Outcomes: Back Pain Visual Analog Scale (VAS)
Time frame: 12 months
Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS).
Time frame: 12 months
Medical Outcomes: Maintenance of Lower Extremity Neurological Function
Time frame: 12 months
Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Yuan, M.D principal investigator
Memorial Orthopaedic Surgical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterolateral Fusion in people with Degenerative Changes and Stenosis, run by SeaSpine, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.