Lumbar Degenerative Disc DiseaseNCT01293981
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
An observational study of Lumbar Degenerative Disc Disease, run by Alphatec Spine, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- PureGen Osteoprogenitor Cell Allograft
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2011to Jan 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with symptomatic lumbar degenerative disc disease (DDD) at 1 or 2 contiguous levels between L1 and S1.
Who may be able to join
- Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level
- Unresponsive to conservative treatment for at least 6 months
- Radiographic confirmation of primary diagnosis
Who cannot join
- More than 2 levels requiring lumbar interbody fusion
- Spondylolisthesis greater than Grade I
- Prior failed fusion surgery at any lumbar level(s)
- Local or systemic infection past or present
- Active systemic disease
- Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
Show all 19Show fewer
- BMI greater than 40
- Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
- Use of post operative Spinal Cord Stimulator (SCS)
- Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
- Known or suspected history of alcohol and/or drug abuse
- Involved in pending litigation or worker's compensation related to the spine
- Pregnant or plans to become pregnant during the course of the study
- Insulin-dependent diabetes mellitus
- Known sensitivity to device materials
- 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
- Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Beverly Hills, California
Study site
Greensboro, North Carolina, 27401
Study site
Middleton, Connecticut, 06457
About this study
Official title: Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures
The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- PureGen Osteoprogenitor Cell Allograft
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Degenerative Disc Disease | Not described Receives: Biological: PureGen Osteoprogenitor Cell Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Proportion of subjects with fusion at the 24 month visit
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 posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 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
- NCT01293981
- Sponsor's protocol ID
- PRO-000058
- Status last verified
- Jan 2016
- First submitted
- 9 Feb 2011
- Last updated
- 20 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures
- ClinicalTrials.gov ID
- NCT01293981
- Acronym / sponsor ID
- PRO-000058
- Conditions
- Lumbar Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Product no longer on the market
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Alphatec Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- First posted
- 11 Feb 2011 (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 assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar Degenerative Disc Disease | – | Biological: PureGen Osteoprogenitor Cell Allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with symptomatic lumbar degenerative disc disease (DDD) at 1 or 2 contiguous levels between L1 and S1.
Key inclusion criteria (3 listed)
- Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level
- Unresponsive to conservative treatment for at least 6 months
- Radiographic confirmation of primary diagnosis
Key exclusion criteria (19 listed)
- More than 2 levels requiring lumbar interbody fusion
- Spondylolisthesis greater than Grade I
- Prior failed fusion surgery at any lumbar level(s)
- Local or systemic infection 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. | Biological | Lumbar Degenerative Disc Disease |
Primary outcome
Fusion
Time frame: 24 months
Proportion of subjects with fusion at the 24 month visit
Results and safety
The study was stopped early (reason given: Product no longer on the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Degenerative Disc Disease, run by Alphatec Spine, Inc. at 3 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 3 inclusion and 19 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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: Product no longer on the market). 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?
Fusion (time frame: 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 20 Jan 2016.