NCT00389597

LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: LDR Spine USA · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Objectives of the Investigation 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 Design Rationale The study is a prospective, randomized, multi-center, concurrently controlled investigation, in which the study device will be compared to the control treatment consisting of conventional anterior cervical discectomy and fusion (ACDF) in accordance with the Smith-Robinson procedure. Patients will be followed for two years postsurgery (primary endpoint) and at 3, 4, 5, and 7 years thereafter. Duration of the Investigation Patients will be followed post-operatively at 6 weeks, and 3-, 6-, 12-, 18-, and 24-months. After 24 months, patients will continue to be followed at 3,4, 5 and 7 years. Design Techniques to Avoid Bias To eliminate selection bias, investigational and control comparison groups will be assigned at random. Institutional Review Board No clinical studies will begin without documented approval of the clinical investigation by the Institutional Review Board (IRB) affiliated with the study center.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Cervical Artificial Disc	Cervical artificial disc mechanical device

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-03-01
• Completion: 2015-11-01
• First posted: 2006-10-19
• Last updated: 2017-12-11
• Results posted: 2014-05-01

Locations

24 sites across 1 country: United States