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NCT00344890 · ClinicalTrials.gov registry record · NA
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
A NA study, sponsored by LifeNet Health.
- Completed
- Registry status
- NA
- Development phase
- 106
- Enrollment target
NCT00344890 is a NA study that has completed, run by LifeNet Health. The registered enrollment target is 106 participants.
The verdict
NCT00344890, a NA study, has completed, sponsored by LifeNet Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Anterior Cervical Discectomy and Fusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00344890
The ClinicalTrials.gov registry entry for NCT00344890 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LifeNet Health, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anterior Cervical Discectomy and Fusion is the first listed.
NCT00344890 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00344890 about?
NCT00344890 is a clinical study titled "Safety Study of Preservon-Treated Bone Implants for Cervical Fusion 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...
What is the current status of trial NCT00344890?
This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2006-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00344890?
The interventions under investigation include: Anterior Cervical Discectomy and Fusion (PROCEDURE).
Who is sponsoring clinical trial NCT00344890?
This trial is sponsored by LifeNet Health, which has 8 total clinical trials registered on ClinicalTrials.gov.
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