StenosisNCT00254852
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
A study testing Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF) and Transforaminal lumbar interbody fusion (TLIF) in people with Stenosis and Spondylolisthesis, run by Exactech at 6 sites in United States.
Trial summary
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- What is being tested?
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF) and Transforaminal lumbar interbody fusion (TLIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2005to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is indicated for primary lumbar fusion of 1 or 2 segments, L2 to S1
- Patient is willing to be blindly randomized to treatment or control and remain blinded for 2 years of follow-up
- Patient is at least twenty-one (21) years of age
- Patient is expected to survive at least 2 years beyond surgery
- Patient is willing to participate by complying with pre- and postoperative visit requirements, including: completion of questionnaires, functional performance tests, and radiographs/CT scan
- Patient is willing and able to review and sign a study Informed Consent form
Who cannot join
- Patient has a mental or physical condition that would invalidate evaluation results
- Patient is pregnant
- Patient is a prisoner
- Patient has a systemic infection or infection at the proposed surgical site
- Patient has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- Patient has a disease of bone metabolism
Show all 9Show fewer
- Patient is undergoing chemotherapy or radiation treatment
- Patient is currently involved in a study of another product for a similar purpose
- Patient requires post-op management with nonsteroidal anti-inflammatory drugs (NSAIDs)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NeuroSpine Solutions, P.C.
Bristol, Tennessee, 37620
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
Slocum Dickson Medical Group
New Hartford, New York, 13413
University of California, San Diego
San Diego, California, 92103
State University of New York, Upstate Medical University
Syracuse, New York, 13202
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below.
The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded to the type of treatment each patient has received.
Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative (post-op). Questionnaires and x-rays will be completed at each visit and a computed tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of bridging bone, where appropriate).
Read the detailed description
Autograft (bone taken from one part of the body and placed in another site on the same individual) has long been considered the gold standard for lumbar spine fusion procedures. Unfortunately, there are complications involved with autograft harvest such as donor site morbidity, increased operating time, and limited supply. Therefore, the use of allograft (bone taken from one body and placed into another individual) as a graft extender has become an acceptable practice, especially in fusions of more than one level where larger quantities of graft material are needed.
In this study, comparisons will be made between patients who are randomized to having fusion with an allograft material (Optecure, Exactech, Inc.) mixed with an autograft to those patients who are randomized to having fusion with autograft alone.
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Being tested
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF), Posterior lumbar interbody fusion (PLIF), Extreme lateral interbody fusion (XLIF)
- Keywords
- Primary lumbar fusion, Demineralized Bone Matrix, DBM, Optecure, Allograft, Autograft, Lumbar fusion, Interbody fusion, Instrumented fusion, Non-instrumented fusion, Exactech, Spinal fusion
- Medical subject headings
- Constriction, Pathologic, Spondylolisthesis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Lateral Fusion (PLF)Procedure or surgery
Also called PLF
Posterior lateral fusion (PLF) of the lumbar spine
Anterior Lumbar Interbody Fusion (ALIF)Procedure or surgery
Also called ALIF
Anterior lumbar interbody fusion (ALIF)
Transforaminal lumbar interbody fusion (TLIF)Procedure or surgery
Also called TLIF
Transforaminal lumbar interbody fusion (TLIF)
Posterior lumbar interbody fusion (PLIF)Procedure or surgery
Also called PLIF
Posterior lumbar interbody fusion (PLIF)
Extreme lateral interbody fusion (XLIF)Procedure or surgery
Also called XLIF
Extreme lateral interbody fusion (XLIF)
| Study group | Role | What they receive |
|---|---|---|
| O | Active comparator | This treatment arm includes autograft harvested from local bone and / or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure. Receives: Procedure: Posterior Lateral Fusion (PLF); Procedure: Anterior Lumbar Interbody Fusion (ALIF); Procedure: Transforaminal lumbar interbody fusion (TLIF); Procedure: Posterior lumbar interbody fusion (PLIF); Procedure: Extreme lateral interbody fusion (XLIF) |
| A | Active comparator | This treatment arm includes autograft harvested from local bone and / or the iliac crest. Receives: Procedure: Posterior Lateral Fusion (PLF); Procedure: Anterior Lumbar Interbody Fusion (ALIF); Procedure: Transforaminal lumbar interbody fusion (TLIF); Procedure: Posterior lumbar interbody fusion (PLIF); Procedure: Extreme lateral interbody fusion (XLIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evidence of fusion on x-rays taken at each post-op visit
Measured: Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year
Secondary outcomes (3)
Oswestry Disability Index (ODI) completed at each visit
Measured: pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
SF-12 patient health surveys completed at each visit
Measured: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
Perceived pain noted on visual analog scales (VAS) at each visit
Measured: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies of the same condition, open and under way.
- More trials run by ExactechThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Fayyazi, MD, Principal investigator, VSAS Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254852
- Sponsor's protocol ID
- CR04-004
- Status last verified
- Nov 2013
- First submitted
- 15 Nov 2005
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine
- ClinicalTrials.gov ID
- NCT00254852
- Acronym / sponsor ID
- CR04-004
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Keywords
- Primary lumbar fusion, Demineralized Bone Matrix, DBM, Optecure, Allograft, Autograft, Lumbar fusion, Interbody fusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 94 participants (actual)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below.
The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded to the type of treatment each patient has received.
Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative (post-op). Questionnaires and x-rays will be completed at each visit and a computed tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of bridging bone, where appropriate).
Detailed description
Autograft (bone taken from one part of the body and placed in another site on the same individual) has long been considered the gold standard for lumbar spine fusion procedures. Unfortunately, there are complications involved with autograft harvest such as donor site morbidity, increased operating time, and limited supply. Therefore, the use of allograft (bone taken from one body and placed into another individual) as a graft extender has become an acceptable practice, especially in fusions of more than one level where larger quantities of graft material are needed.
In this study, comparisons will be made between patients who are randomized to having fusion with an allograft material (Optecure, Exactech, Inc.) mixed with an autograft to those patients who are randomized to having fusion with autograft alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O | Active comparator | Procedure: Posterior Lateral Fusion (PLF), Procedure: Anterior Lumbar Interbody Fusion (ALIF), Procedure: Transforaminal lumbar interbody fusion (TLIF), Procedure: Posterior lumbar interbody fusion (PLIF), Procedure: Extreme lateral interbody fusion (XLIF)This treatment arm includes autograft harvested from local bone and / or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure. |
| A | Active comparator | Procedure: Posterior Lateral Fusion (PLF), Procedure: Anterior Lumbar Interbody Fusion (ALIF), Procedure: Transforaminal lumbar interbody fusion (TLIF), Procedure: Posterior lumbar interbody fusion (PLIF), Procedure: Extreme lateral interbody fusion (XLIF)This treatment arm includes autograft harvested from local bone and / or the iliac crest. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is indicated for primary lumbar fusion of 1 or 2 segments, L2 to S1
- Patient is willing to be blindly randomized to treatment or control and remain blinded for 2 years of follow-up
- Patient is at least twenty-one (21) years of age
- Patient is expected to survive at least 2 years beyond surgery
- Patient is willing to participate by complying with pre- and postoperative visit requirements, including: completion of questionnaires, functional performance tests, and radiographs/CT scan
Key exclusion criteria (9 listed)
- Patient has a mental or physical condition that would invalidate evaluation results
- Patient is pregnant
- Patient is a prisoner
- Patient has a systemic infection or infection at the proposed surgical site
- Patient has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
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 |
|---|---|---|
| Posterior Lateral Fusion (PLF)Also: PLFPosterior lateral fusion (PLF) of the lumbar spine | Procedure or surgery | A, O |
| Anterior Lumbar Interbody Fusion (ALIF)Also: ALIFAnterior lumbar interbody fusion (ALIF) | Procedure or surgery | A, O |
| Transforaminal lumbar interbody fusion (TLIF)Also: TLIFTransforaminal lumbar interbody fusion (TLIF) | Procedure or surgery | A, O |
| Posterior lumbar interbody fusion (PLIF)Also: PLIFPosterior lumbar interbody fusion (PLIF) | Procedure or surgery | A, O |
| Extreme lateral interbody fusion (XLIF)Also: XLIFExtreme lateral interbody fusion (XLIF) | Procedure or surgery | A, O |
Primary outcome
Radiographic evidence of fusion on x-rays taken at each post-op visit
Time frame: Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year
3 secondary outcomes
Oswestry Disability Index (ODI) completed at each visit
Time frame: pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
SF-12 patient health surveys completed at each visit
Time frame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
Perceived pain noted on visual analog scales (VAS) at each visit
Time frame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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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.
Amir Fayyazi, MD principal investigator
VSAS Orthopedics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF) and Transforaminal lumbar interbody fusion (TLIF) in people with Stenosis and Spondylolisthesis, run by Exactech at 6 sites 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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?
Radiographic evidence of fusion on x-rays taken at each post-op visit (time frame: Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year). 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 21 Nov 2013.