LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Public ClinicalTrials.gov record NCT00389597. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment.
Study identification
- NCT ID
- NCT00389597
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 599 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 69 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2006 (Type not available)
- Primary completion
- Mar 2010 (Actual)
- Completion
- Nov 2015 (Actual)
- Last update posted
- Dec 11, 2017
2006 – 2015
United States locations
- U.S. sites
- 24
- U.S. states
- 12
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Texas Back Institute-West | Phoenix | Arizona | 85015 | — |
| Southern California Institute of Neurological Surgery | Escondido | California | 92122 | — |
| Massoudi & Jackson Neurosurgical Association | Laguna Hills | California | 92653 | — |
| Memorial Orthopaedic Surgical Group | Long Beach | California | 90806 | — |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | — |
| University of California- Davis Medical Center | Sacramento | California | 95817 | — |
| Spine Institute at St. John's Health Center | Santa Monica | California | 90404 | — |
| Stanford University | Stanford | California | 94305 | — |
| Panorama Orthopedics and Spine Care | Golden | Colorado | 80401 | — |
| Southeastern Clinical Research | Orlando | Florida | 32804 | — |
| Orthopaedics North East | Fort Wayne | Indiana | 46825 | — |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | — |
| GBMC Healthcare | Baltimore | Maryland | 21204 | — |
| University Neurologic Systems | Detroit | Michigan | 48201 | — |
| St. Mary's of Saginaw Field Neurosciences Institute | Saginaw | Michigan | 48604 | — |
| Simmons Orthopaedics and Spine Associates | Buffalo | New York | 14201 | — |
| Orthopedic Spine Care of Long Island | Melville | New York | 11747 | — |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oklahoma Spine & Brain Institute | Tulsa | Oklahoma | 74132 | — |
| Austin Brain and Spine | Austin | Texas | 78701 | — |
| Foundation Surgical Hospital | Houston | Texas | 77401 | — |
| West Texas Spine | Odessa | Texas | 79761 | — |
| Texas Back Institute | Plano | Texas | 75093 | — |
| Texas Spine and Joint Hospital | Tyler | Texas | 75701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00389597, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2017 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00389597 live on ClinicalTrials.gov.