Degenerative ChangesNCT01873586
OsteoStrux™ Collagen Ceramic Scaffold 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's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate 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
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 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
- Are 18 (eighteen) years of age or older at the time of surgery.
- Require spinal fusion using TLIF, PLF or PLIF, with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1.
- Are 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 3 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.
- Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
- Are 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. 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, or has established osteoporosis (i.e. has had one or more fragility fractures).
- Are pregnant, lactating or women wishing to become pregnant.
- Are a prisoner.
Show all 11Show fewer
- BMI ≥ 40
- Are smokers and/or nicotine/tobacco users
- 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.
- Had 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 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sherban Orthopaedic and Spine Surgery, PLLC
Kenmore, New York, 14217
About this study
Official title: Efficacy and Safety of OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate 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 |
|---|---|---|
| OsteoStrux Collagen Ceramic Scaffold | Experimental | OsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side) Receives: Procedure: Posterolateral Fusion |
| Local autograft | Active comparator | Local autograft (posterolateral gutter at the contralateral side) Receives: Procedure: Posterolateral Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.
Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Measured: up to 24 months
Secondary outcomes (9)
Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT
Each posterolateral gutter was assessed for extent of fusion using computed tomography (CT) scan.
Measured: 12 months
Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months
NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was indistinguishable per arms, data were not collected due to a limitation in the method of analysis per protocol. Therefore data was not analyzed and outcome is NA.
Measured: upto 24 months
Interbody Fusion as Determined by CT Post-surgery at Available Time-points
NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.
Measured: 12 months
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points
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 descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which results in a 1-5 level selected for that dimension. The level when added together describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Score is 0-100 and a lower score represents a better score.
Measured: upto 24 months
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan
Correlation of x-ray with computed tomography scan analysis at the 12 month follow-up time point.
Measured: 12 months
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.
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: upto 24 months
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.
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: upto 24 months
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.
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 back pain. A lower score represents a better score.
Measured: upto 24 months
Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.
Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral 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 posterolateral sides in a neurological function assessment. Neurological function is indistinguishable between the right and left posterolateral sides of the lower extremities using the methods in the protocol. Therefore, this outcomes measure was not applicable.
Measured: upto 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionOct 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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaSpine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ross Sherban, DO, Principal investigator, Sherban Orthopaedic and Spine Surgery, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873586
- Sponsor's protocol ID
- OSX-US-2012-1
- Status last verified
- Mar 2019
- First submitted
- 24 May 2013
- Last updated
- 17 Jun 2019
- 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 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
- ClinicalTrials.gov ID
- NCT01873586
- Acronym / sponsor ID
- OSX-US-2012-1
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- SeaSpine, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Posted 17 Jun 2019
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's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsteoStrux Collagen Ceramic Scaffold | Experimental | Procedure: Posterolateral FusionOsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side) |
| Local autograft | Active comparator | Procedure: Posterolateral FusionLocal autograft (posterolateral gutter at the contralateral 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 TLIF, PLF or PLIF, with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1.
- Are 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 3 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.
- Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
- Are willing and able to sign study specific informed consent.
Key exclusion criteria (11 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. 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, or has established osteoporosis (i.e. has had one or more fragility fractures).
- Are pregnant, lactating 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 |
|---|---|---|
| Posterolateral Fusion | Procedure or surgery | Local autograft, OsteoStrux Collagen Ceramic Scaffold |
Primary outcome
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.
Time frame: up to 24 months
Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
9 secondary outcomes
Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT
Time frame: 12 months
Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months
Time frame: upto 24 months
Interbody Fusion as Determined by CT Post-surgery at Available Time-points
Time frame: 12 months
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points
Time frame: upto 24 months
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan
Time frame: 12 months
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.
Time frame: upto 24 months
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.
Time frame: upto 24 months
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.
Time frame: upto 24 months
Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.
Time frame: upto 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- 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.
Ross Sherban, DO principal investigator
Sherban Orthopaedic and Spine Surgery, PLLC
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 11 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 17 Jun 2019. 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 17 Jun 2019). 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 Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. (time frame: up to 24 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 17 Jun 2019.