LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

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.
    

Intervention name(s): Cervical Artificial Disc
Intervention type(s): Device
Intervention description(s): Cervical artificial disc mechanical device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: degenerative disc disease; cervical arthroplasty; Mobi C; multilevel; anterior cervical discectomy and fusion