Cervical RadiculopathyNCT00344890
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
A study testing Anterior Cervical Discectomy and Fusion in people with Cervical Radiculopathy and Myelopathy, run by LifeNet Health at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy, Myelopathy
- What is being tested?
- Anterior Cervical Discectomy and Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is skeletally mature
- Patient has confirmed radiculopathy or myelopathy
- Pain unresponsive to non-operative treatment
- Radicular pain in either or both upper extremities
- Neurological deficit in distribution of nerve root from C3/4 to C6/7
- Patient's lateral cervical spine x-rays show inferior aspect of lowest vertebral body to be fused
- Patient agrees to comply with protocol
- Patient can provide voluntary informed consent and follow-up information
Who cannot join
- Patient has previous cervical spine surgery
- Patient requires concurrent posterior surgery at level to be treated, or anterior and posterior surgery at any other cervical level
- Patient has clinically compromised vertebral body structure
- Patient has multi-level fixed/ankylosed cervical spine
- Patient has signs of significant instability at level to be treated or adjacent level
- Patient has history of metabolic bone disease
Show all 13Show fewer
- Patient is taking chronic oral/IV corticosteroid therapy OR medications that potentially interfere with bone/soft tissue healing
- Patient has progressive neuromuscular disease, rheumatoid arthritis, active malignancy, OR any other condition that interferes with self-assessment of pain, function, or quality of life
- Patient has OPLL at any level
- Patient has active infection, local or systemic
- Patient is pregnant or considering pregnancy (x-ray requirements)
- Patient is participating in another investigational study
- Patient belongs to vulnerable population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Efficacy Comparison of Preservon Treated Allograft Bone Dowels Versus Traditional Freeze-Dried Allograft Bone Dowels for Fusion of Degenerated Cervical Intervertebral Discs in the Treatment of Cervical Radiculopathy or Myelopathy
The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy.
Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after surgery, the implanted bone dowels will be assessed for fusion. Patients will complete questionnaires and x-rays taken at each visit.
The degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received.
- Conditions
- Cervical Radiculopathy, Myelopathy
- Being tested
- Anterior Cervical Discectomy and Fusion
- Keywords
- Cervical fusion, Anterior Cervical Discectomy and Fusion, ACDF
- Medical subject headings
- Radiculopathy, Spinal Cord Diseases, Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Discectomy and FusionProcedure or surgery
1,2,3,or 4 level surgery
| Study group | Role | What they receive |
|---|---|---|
| Preservon | Experimental | Not described Receives: Procedure: Anterior Cervical Discectomy and Fusion |
| Control | Active comparator | Not described Receives: Procedure: Anterior Cervical Discectomy and Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of subsidence
Measured: 3 months post-op
Rate of fusion
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2011
- Study completionDec 2012
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 Cervical RadiculopathyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce E. Mathern, M.D., Principal investigator, VCU Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344890
- Sponsor's protocol ID
- CR06-001
- Other IDs
- WIRB Protocol #20061453
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2006
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Graham RS, Samsell BJ, Proffer A, Moore MA, Vega RA, Stary JM, Mathern B. Evaluation of glycerol-preserved bone allografts in cervical spine fusion: a prospective, randomized controlled trial. J Neurosurg Spine. 2015 Jan;22(1):1-10. doi: 10.3171/2014.9.SPINE131005.
PubMed 25360528
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Comparison of Preservon Treated Allograft Bone Dowels Versus Traditional Freeze-Dried Allograft Bone Dowels for Fusion of Degenerated Cervical Intervertebral Discs in the Treatment of Cervical Radiculopathy or Myelopathy
- ClinicalTrials.gov ID
- NCT00344890
- Acronym / sponsor ID
- CR06-001
- Conditions
- Cervical Radiculopathy, Myelopathy
- Keywords
- Cervical fusion, Anterior Cervical Discectomy and Fusion, ACDF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2006 (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 the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy.
Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after surgery, the implanted bone dowels will be assessed for fusion. Patients will complete questionnaires and x-rays taken at each visit.
The degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preservon | Experimental | Procedure: Anterior Cervical Discectomy and Fusion |
| Control | Active comparator | Procedure: Anterior Cervical Discectomy and Fusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is skeletally mature
- Patient has confirmed radiculopathy or myelopathy
- Pain unresponsive to non-operative treatment
- Radicular pain in either or both upper extremities
- Neurological deficit in distribution of nerve root from C3/4 to C6/7
Key exclusion criteria (13 listed)
- Patient has previous cervical spine surgery
- Patient requires concurrent posterior surgery at level to be treated, or anterior and posterior surgery at any other cervical level
- Patient has clinically compromised vertebral body structure
- Patient has multi-level fixed/ankylosed cervical spine
- Patient has signs of significant instability at level to be treated or adjacent level
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 |
|---|---|---|
| Anterior Cervical Discectomy and Fusion1,2,3,or 4 level surgery | Procedure or surgery | Control, Preservon |
Primary outcome
Degree of subsidence
Time frame: 3 months post-op
Rate of fusion
Time frame: 6 months post-op
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 7 Apr 2015.
- Results publication: PubMed 25360528Graham RS, Samsell BJ, Proffer A, Moore MA, Vega RA, Stary JM, Mathern B. Evaluation of glycerol-preserved bone allografts in cervical spine fusion: a prospective, randomized controlled trial. J Neurosurg Spine. 2015 Jan;22(1):1-10. doi: 10.3171/2014.9.SPINE131005.
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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.
Bruce E. Mathern, M.D. principal investigator
VCU Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cervical Discectomy and Fusion in people with Cervical Radiculopathy and Myelopathy, run by LifeNet Health 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 8 inclusion and 13 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 7 Apr 2015. 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?
Degree of subsidence (time frame: 3 months post-op). The study lists 2 primary outcomes in all. 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 NCT00344890, 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 7 Apr 2015.