Degenerative Disc DiseasePEEKNCT01406405
PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries
An observational study of Degenerative Disc Disease, run by Justin Parker Neurological Institute at 1 site in United States.
Trial summary
Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 16 May 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Boulder Neurosurgical Associates patients
Who may be able to join
- Skeletally mature adults between 18 and 70 years old
- Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels
- Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
- Willing and able to comply with the requirements of the protocol including followup requirements
- Willing and able to sign a study specific informed consent.
- Skeletally mature adults between 18 and 70 years old
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- Patients with neck and/or arm pain due to degenerative disc disease, scheduled for ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3 adjacent levels
- Completed at least 6 weeks of conservative therapy or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
- Willing and able to comply with the requirements of the protocol including followup requirements
- Willing and able to sign a study specific informed consent
Who cannot join
- More than 3 intervertebral levels to be fused
- Posterior fixation used at more than 1 level for 1-level intervertebral fusion
- Posterior fixation used at more than 2 levels for 2-level intervertebral fusion
- Posterior fixation used at more than 3 levels for 3-level intervertebral fusion
- Any additional approaches, e.g. anterior, XLIF
- Active local or systemic infection
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- Prior interbody fusion surgery at the index level
- Prior fusion at the adjacent levels
- Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
- Cervical Fusion Patient Group
- More than 3 vertebral levels to be fused
- Any additional approaches, e.g. posterior cervical fusion
- Active local or systemic infection
- Prior interbody fusion surgery at the index level
- Prior fusion at the adjacent level
- Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Neurosurgical Associates
Boulder, Colorado, 80304
About this study
Official title: Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries
Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.
Read the detailed description
Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.
- Conditions
- Degenerative Disc Disease
- Being tested
- Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)
- Keywords
- Degenerative disc disease, spinal stenosis, herniated disc
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)Procedure or surgery
Lumbar or cervical fusion
| Study group | Role | What they receive |
|---|---|---|
| PEEK cages | Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages Receives: Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF) | |
| Allograft spacers | Patients will have fusion surgery performed using allograft spacers Receives: Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Scores
Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment.
Measured: 24 (+/- 2) months
Secondary outcomes (1)
Clinical and Radiographic Outcomes
- Assessment of Neck or Lower Back Disability Scores
- Assessment of SF-36 Health Survey
- Assessment of restoration of vertebral height, sagittal alignment, and graft subsidence
- Assessment of fusion rates
Measured: 3 (+/-2) weeks and 24 (+/- 2) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justin Parker Neurological Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan T Villavicencio, MD, Principal investigator, Boulder Neurosurgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406405
- Sponsor's protocol ID
- JPNI2001-2
- Acronym
- PEEK
- Status last verified
- Feb 2019
- First submitted
- 27 Jul 2011
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Villavicencio AT, Nelson EL, Kantha V, Burneikiene S. Prediction based on preoperative opioid use of clinical outcomes after transforaminal lumbar interbody fusions. J Neurosurg Spine. 2017 Feb;26(2):144-149. doi: 10.3171/2016.7.SPINE16284. Epub 2016 Sep 30.
PubMed 27689425
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing PEEK and Allograft Spacers in Patients Undergoing Spinal Intervertebral Fusion Surgeries
- ClinicalTrials.gov ID
- NCT01406405
- Acronym / sponsor ID
- PEEK / JPNI2001-2
- Conditions
- Degenerative Disc Disease
- Keywords
- Degenerative disc disease, spinal stenosis, herniated disc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Justin Parker Neurological InstituteUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 1 Aug 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.
Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.
Detailed description
Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK cages | – | Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages |
| Allograft spacers | – | Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)Patients will have fusion surgery performed using allograft spacers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Boulder Neurosurgical Associates patients
Key inclusion criteria (10 listed)
- Skeletally mature adults between 18 and 70 years old
- Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels
- Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
- Willing and able to comply with the requirements of the protocol including followup requirements
- Willing and able to sign a study specific informed consent.
Key exclusion criteria (16 listed)
- More than 3 intervertebral levels to be fused
- Posterior fixation used at more than 1 level for 1-level intervertebral fusion
- Posterior fixation used at more than 2 levels for 2-level intervertebral fusion
- Posterior fixation used at more than 3 levels for 3-level intervertebral fusion
- Any additional approaches, e.g. anterior, XLIF
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/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)Lumbar or cervical fusion | Procedure or surgery | Allograft spacers, PEEK cages |
Primary outcome
Pain Intensity Scores
Time frame: 24 (+/- 2) months
Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment.
1 secondary outcome
Clinical and Radiographic Outcomes
Time frame: 3 (+/-2) weeks and 24 (+/- 2) months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 27689425Villavicencio AT, Nelson EL, Kantha V, Burneikiene S. Prediction based on preoperative opioid use of clinical outcomes after transforaminal lumbar interbody fusions. J Neurosurg Spine. 2017 Feb;26(2):144-149. doi: 10.3171/2016.7.SPINE16284. Epub 2016 Sep 30.
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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.
Alan T Villavicencio, MD principal investigator
Boulder Neurosurgical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Justin Parker Neurological Institute 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 10 inclusion and 16 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 27 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Intensity Scores (time frame: 24 (+/- 2) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01406405, which also lists 1 linked publication.
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 27 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.