StenosisNCT01430299

Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion

A study testing Demineralized Bone Matrix and rh-BMP2 in people with Stenosis and Spondylosis, run by SeaSpine, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stenosis, Spondylosis, Degenerative Changes
What is being tested?: Demineralized Bone Matrix and rh-BMP2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Oct 2016
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

Age 18 years of age or older at the time of surgery
Require spinal fusion using posterior Transforaminal Lumbar Interbody Fusion (TLIF), Posterolateral Fusion (PLF) or Posterior Lumber Interbody Fusion (PLIF) in 1 to 3 levels between L3-S1
Follow-up radiographic imaging post surgery

Who cannot join

Long term users of medications known to inhibit fusion,bone metabolism or epidural steroid injections
Immunosuppressive agents, Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs, Growth Factors or Insulin
Treated with radiotherapy since their surgery
Medical conditions known to impact bone metabolism, such as Paget's disease, osteoporosis
Pregnant or lactating women or women wishing to become pregnant
Prisoner
Participating in an investigational drug or another device study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery
Sacramento, California, 95816

Other trials in United States

About this study

Official title: Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion

Read the detailed description

Conditions: Stenosis, Spondylosis, Degenerative Changes
Being tested: Demineralized Bone Matrix, rh-BMP2
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.

Demineralized Bone MatrixDevice
Also called Accell Evo3
Accell Evo3 in posteriolateral fusion (prospective cohort)
rh-BMP2Device
Also called Infuse
rh-BMP2 in posterolateral fusion (retrospective cohort)

Study groups in NCT01430299
Study group	Role	What they receive
Demineralized Bone Matrix	Other	a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space Receives: Device: Demineralized Bone Matrix
rh-BMP2	Other	A retrospective cohort of patients who were age- and sex- matched to the prospective cohort who underwent posterolateral lumbar fusion with use of rh-BMP2 Receives: Device: rh-BMP2

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
Posterolateral fusion by radiographic assessment 12 months post surgery
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Oct 2016

First posted8 Sep 2011 (estimated)
Study startJun 2011
Primary completionMar 2016
Study completionOct 2016

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 StenosisStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01430299
Sponsor's protocol ID: ACC3-US-2010-1
Status last verified: May 2018
First submitted: 30 Aug 2011
Last updated: 7 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion
ClinicalTrials.gov ID: NCT01430299
Acronym / sponsor ID: ACC3-US-2010-1
Conditions: Stenosis, Spondylosis, Degenerative Changes
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: SeaSpine, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Mar 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 8 Sep 2011 (estimated)
Results: Posted 28 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Demineralized Bone Matrix	Other	Device: Demineralized Bone Matrixa prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
rh-BMP2	Other	Device: rh-BMP2A retrospective cohort of patients who were age- and sex- matched to the prospective cohort who underwent posterolateral lumbar fusion with use of rh-BMP2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18 years of age or older at the time of surgery
Require spinal fusion using posterior Transforaminal Lumbar Interbody Fusion (TLIF), Posterolateral Fusion (PLF) or Posterior Lumber Interbody Fusion (PLIF) in 1 to 3 levels between L3-S1
Follow-up radiographic imaging post surgery

Key exclusion criteria (7 listed)

Long term users of medications known to inhibit fusion,bone metabolism or epidural steroid injections
Immunosuppressive agents, Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs, Growth Factors or Insulin
Treated with radiotherapy since their surgery
Medical conditions known to impact bone metabolism, such as Paget's disease, osteoporosis
Pregnant or lactating women or women wishing to become pregnant

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
Demineralized Bone MatrixAlso: Accell Evo3Accell Evo3 in posteriolateral fusion (prospective cohort)	Device	Demineralized Bone Matrix
rh-BMP2Also: Infuserh-BMP2 in posterolateral fusion (retrospective cohort)	Device	rh-BMP2

Primary outcome

Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
Time frame: 12 months
Posterolateral fusion by radiographic assessment 12 months post surgery

Results and safety

Results posted to the registry on 28 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OsteoSurg 300	20	16
rhBMP-2	23	21

Primary outcome: Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery

Time frame: 12 months. Count of units. Unit: radiographic assessments

Measure	OsteoSurg 300 n = 16	rhBMP-2 n = 21
Value	43	74

Population analysed: One to 3 spinal levels between L3 and S1 were treated per patient. Fusion was assessed twice per treated level. There were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels but 46 OsteoSurge assessments and 74 rhBMP-2 assessments.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OsteoSurg 300	5 of 16 (31.3%)	9 of 16 (56.3%)	0 of 16
rhBMP-2	3 of 21 (14.3%)	15 of 21 (71.4%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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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.

Eric Klineberg, M.D. principal investigator

University of CA - Davis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Demineralized Bone Matrix and rh-BMP2 in people with Stenosis and Spondylosis, 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 3 inclusion and 7 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 7 Jun 2018. 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 28 Feb 2018). 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?

Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430299.

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 7 Jun 2018.