Cervical Degenerative Disc DiseaseNCT01291134
PureGen: Radiographic Analysis of Fusion for ACDF
An observational study of Cervical Degenerative Disc Disease, run by Alphatec Spine, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the rate and quality of spinal fusion utilizing PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- PureGen Osteoprogenitor Cell Allograft
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2011to Aug 2013
- 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 suffering from symptoms of cervical degenerative disc disease (DDD) in one to four contiguous levels between C3 and T1.
Who may be able to join
- Persistent neck and/or arm pain consistent to symptomatic cervical degenerative disc disease
- Moderate Neck Disability Index
- Unresponsive to conservative treatment for at least 6 weeks
Who cannot join
- More than 4 levels requiring surgical treatment
- Prior failed fusion surgery at the index 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
- Known or suspected history of alcohol and/or drug abuse
Show all 14Show fewer
- Involved in pending litigation or worker's compensation relating to the spine
- Pregnant or plans to become pregnant during the duration of the study
- Insulin-dependent diabetes mellitus
- Life expectancy less than study duration
- Any significant psychological disturbance that in the opinion of the Investigator could impair consent process or ability to complete self-assessment questionnaires
- BMI greater than 40
- 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
4 sites in 1 country.
United States4 sites
Alphatec Spine Inc.
Carlsbad, California, 92008
Study site
Greensboro, North Carolina, 27401
Study site
Middletown, Connecticut, 06457
Study site
Raleigh, North Carolina, 27607
About this study
Official title: PureGen Osteoprogenitor Cell Allograft: A Radiographic Analysis of Rate and Quality of Fusion in Patients Undergoing Anterior Cervical Discectomy and Fusion (ACDF)
The purpose of this study is to evaluate the rate and quality of spinal fusion utilizing PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).
Read the detailed description
This is a prospective, multi-center, post-market, observational study assessing subjects undergoing cervical interbody fusion surgery to treat cervical degenerative disc disease (DDD)
Patients diagnosed with cervical degenerative disc disease 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 ACDF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), a radiolucent cervical interbody spacer, and Trestle or Reveal Anterior Cervical Plating System (plate and screw fixation system).
Subjects will be followed at 6- weeks, 3-, 6-, and 12-month post-operative visits. Standard radiographs will be taken at these visits to assess fusion rate and quality. SF-12, NDI and VAS self assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography scan will be taken at the 6 month post operative exam to further assess rate and quality of fusion. A conditional 12-month post operative CT may also be taken. Procedure related and device related adverse events will be monitored throughout the study.
Outcome data will be compared to published and/or retrospective data for the standard of care for DDD patients undergoing ACDF.
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- PureGen Osteoprogenitor Cell Allograft
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 |
|---|---|---|
| Cervical Degenerative Disc Disease | Subjects suffering from symptoms of cervical degenerative disc disease in one to four contiguous levels between C3 and T1. 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 12-month visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionAug 2013
Why it stopped: Product is 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 Cervical 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alphatec Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bita P. Ghadimi, Study director, Alphatec Spine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291134
- Sponsor's protocol ID
- PRO-000053
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2011
- Last updated
- 3 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PureGen Osteoprogenitor Cell Allograft: A Radiographic Analysis of Rate and Quality of Fusion in Patients Undergoing Anterior Cervical Discectomy and Fusion (ACDF)
- ClinicalTrials.gov ID
- NCT01291134
- Acronym / sponsor ID
- PRO-000053
- Conditions
- Cervical Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Product is no longer on the market
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alphatec Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 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 evaluate the rate and quality of spinal fusion utilizing PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).
Detailed description
This is a prospective, multi-center, post-market, observational study assessing subjects undergoing cervical interbody fusion surgery to treat cervical degenerative disc disease (DDD)
Patients diagnosed with cervical degenerative disc disease 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 ACDF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), a radiolucent cervical interbody spacer, and Trestle or Reveal Anterior Cervical Plating System (plate and screw fixation system).
Subjects will be followed at 6- weeks, 3-, 6-, and 12-month post-operative visits. Standard radiographs will be taken at these visits to assess fusion rate and quality. SF-12, NDI and VAS self assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography scan will be taken at the 6 month post operative exam to further assess rate and quality of fusion. A conditional 12-month post operative CT may also be taken. Procedure related and device related adverse events will be monitored throughout the study.
Outcome data will be compared to published and/or retrospective data for the standard of care for DDD patients undergoing ACDF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Degenerative Disc Disease | – | Biological: PureGen Osteoprogenitor Cell AllograftSubjects suffering from symptoms of cervical degenerative disc disease in one to four contiguous levels between C3 and T1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from symptoms of cervical degenerative disc disease (DDD) in one to four contiguous levels between C3 and T1.
Key inclusion criteria (3 listed)
- Persistent neck and/or arm pain consistent to symptomatic cervical degenerative disc disease
- Moderate Neck Disability Index
- Unresponsive to conservative treatment for at least 6 weeks
Key exclusion criteria (14 listed)
- More than 4 levels requiring surgical treatment
- Prior failed fusion surgery at the index 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
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 | Cervical Degenerative Disc Disease |
Primary outcome
Fusion
Time frame: 12 months
Proportion of subjects with fusion at the 12-month visit
Results and safety
The study was stopped early (reason given: Product is no longer on the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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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.
Bita P. Ghadimi study director
Alphatec Spine, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Degenerative Disc Disease, run by Alphatec Spine, Inc. at 4 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 14 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 is 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: 12 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 3 Mar 2022.