Lumbar Degenerative Disc DiseaseNCT01294007
Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)
A study testing PureGen Osteoprogenitor Cell Allograft and Autograft bone in people with Lumbar Degenerative Disc Disease, run by Alphatec Spine, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- PureGen Osteoprogenitor Cell Allograft and Autograft bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic lumbar degenerative disc disease in up to two contiguous levels between L1 and S1
- Subjects with back and/or leg pain indicated for posterior stabilization with or without decompression at any level and posterolateral fusion (PLF)
- Unresponsive to conservative treatment for at least 6 months
- Radiographic evidence of primary diagnosis
Who cannot join
- More than 2 levels requiring posterolateral fusion
- Spondylolisthesis greater than Grade I
- Prior failed fusion surgery at any lumbar level(s)
- Systemic or local infection in the disc or cervical spine, past or present
- Active systemic disease
- Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
Show all 17Show fewer
- Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
- BMI greater than 40
- Use of post operative Spinal Cord Stimulator (SCS)
- Known or suspected history of alcohol and/or drug abuse
- Involved in pending litigation or worker's compensation related to the spine
- Pregnant or planning to become pregnant during the course of the study
- Insulin-dependent diabetes mellitus
- Life expectancy less than duration of study
- Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires
- Undergoing chemotherapy or radiation treatment, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs.
- Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Radiographic Analysis Using PureGen Osteoprogenitor Cell Allograft Versus Autologous Bone in Posterolateral Fusion in a Side-by-Side Comparison in the Same Patient (PLF)
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.
Read the detailed description
This is a prospective, multi-center, observational, self-control study assessing screened and consented subjects undergoing instrumented posterolateral fusion for degenerative disc disease (DDD) at 1 to 2 contiguous levels between L1 and S1.
Patients diagnosed with DDD will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo PLF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), and ZODIAC, Illico, or Xenon Fixation system (pedicle screw and rod fixation system)
Subjects will be followed at 6 weeks, 3, 6, 12 and 24 month post-operative visits. Standard radiographs will be taken at these visits to evaluate fusion rate and quality. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) self-assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography (CT) scan will be taken at the 6-month to further assess rate and quality of fusion. A conditional 12 and 24 month post operative CT may also be taken. Procedure related and PureGen related adverse events will be monitored throughout the study.
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- PureGen Osteoprogenitor Cell Allograft, Autograft bone
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureGen Osteoprogenitor Cell AllograftBiological
PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.
Autograft boneProcedure or surgery
Iliac Crest and Local Autograft Bone
| Study group | Role | What they receive |
|---|---|---|
| Study Graft Composite | Experimental | AlphaGraft ProFuse Demineralized Bone Scaffold are soaked in PureGen according to Preparation for Use and handling technique. The graft composite is placed on the randomized study side contralateral to the autograft bone graft per surgeon's standard technique for PLF. The wound is closed according to surgeon's standard technique.
Post operative care will be according to the site specific standard of care. An avoidance of heavy physical activity and limitations on working, lifting, bending etc. are common precautions post procedure. The decision to use a post operative orthosis is left to the discretion of the Investigator. Receives: Biological: PureGen Osteoprogenitor Cell Allograft |
| Control Graft Composite | Active comparator | Contralateral to the study graft composite, placement of posterolateral fusion graft composite containing iliac crest bone (5 cc/level/side) and local autograft composite (equal volume split with study side). Supplemental posterior pedicle screw fixation utilizing Zodiac, Illico or Xenon Spinal Fixation system.
* A defined volume of iliac crest bone graft (indicated in table 2) is harvested and combined with 50% of the previously harvest morselized local bone
* The graft composite is placed on the randomized control side using standard technique for PLF Receives: Procedure: Autograft bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Fusion
Number of patients with fusion at the 6- and conditional 12- and 24-month visit
Measured: 6, 12 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Product no longer on the market
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 Lumbar Degenerative Disc DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alphatec Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294007
- Sponsor's protocol ID
- PRO-000061
- Status last verified
- Sep 2022
- First submitted
- 9 Feb 2011
- Last updated
- 2 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Radiographic Analysis Using PureGen Osteoprogenitor Cell Allograft Versus Autologous Bone in Posterolateral Fusion in a Side-by-Side Comparison in the Same Patient (PLF)
- ClinicalTrials.gov ID
- NCT01294007
- Acronym / sponsor ID
- PRO-000061
- Conditions
- Lumbar Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Product no longer on the market
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Alphatec Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 5 Oct 2022
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 evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.
Detailed description
This is a prospective, multi-center, observational, self-control study assessing screened and consented subjects undergoing instrumented posterolateral fusion for degenerative disc disease (DDD) at 1 to 2 contiguous levels between L1 and S1.
Patients diagnosed with DDD will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo PLF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), and ZODIAC, Illico, or Xenon Fixation system (pedicle screw and rod fixation system)
Subjects will be followed at 6 weeks, 3, 6, 12 and 24 month post-operative visits. Standard radiographs will be taken at these visits to evaluate fusion rate and quality. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) self-assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography (CT) scan will be taken at the 6-month to further assess rate and quality of fusion. A conditional 12 and 24 month post operative CT may also be taken. Procedure related and PureGen related adverse events will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Graft Composite | Experimental | Biological: PureGen Osteoprogenitor Cell AllograftAlphaGraft ProFuse Demineralized Bone Scaffold are soaked in PureGen according to Preparation for Use and handling technique. The graft composite is placed on the randomized study side contralateral to the autograft bone graft per surgeon's standard technique for PLF. The wound is closed according to surgeon's standard technique. Post operative care will be according to the site specific standard of care. An avoidance of heavy physical activity and limitations on working, lifting, bending etc. are common precautions post procedure. The decision to use a post operative orthosis is left to the discretion of the Investigator. |
| Control Graft Composite | Active comparator | Procedure: Autograft boneContralateral to the study graft composite, placement of posterolateral fusion graft composite containing iliac crest bone (5 cc/level/side) and local autograft composite (equal volume split with study side). Supplemental posterior pedicle screw fixation utilizing Zodiac, Illico or Xenon Spinal Fixation system. * A defined volume of iliac crest bone graft (indicated in table 2) is harvested and combined with 50% of the previously harvest morselized local bone * The graft composite is placed on the randomized control side using standard technique for PLF |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic lumbar degenerative disc disease in up to two contiguous levels between L1 and S1
- Subjects with back and/or leg pain indicated for posterior stabilization with or without decompression at any level and posterolateral fusion (PLF)
- Unresponsive to conservative treatment for at least 6 months
- Radiographic evidence of primary diagnosis
Key exclusion criteria (17 listed)
- More than 2 levels requiring posterolateral fusion
- Spondylolisthesis greater than Grade I
- Prior failed fusion surgery at any lumbar level(s)
- Systemic or local infection in the disc or cervical spine, past or present
- Active systemic disease
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 |
|---|---|---|
| PureGen Osteoprogenitor Cell AllograftPureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation. | Biological | Study Graft Composite |
| Autograft boneIliac Crest and Local Autograft Bone | Procedure or surgery | Control Graft Composite |
Primary outcome
Number of Patients With Fusion
Time frame: 6, 12 and 24 month
Number of patients with fusion at the 6- and conditional 12- and 24-month visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PureGen Osteoprogenitor Cell Allograft and Autograft bone in people with Lumbar Degenerative Disc Disease, run by Alphatec Spine, 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 4 inclusion and 17 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 2 Nov 2022. 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 5 Oct 2022). 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 Patients With Fusion (time frame: 6, 12 and 24 month). 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 2 Nov 2022.