Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical … (NCT00344890) | Clinical Trial Compass
CompletedNot Applicable
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
United States106 participantsStarted 2006-09
Plain-language 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.
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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 vu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.