Last updated on July 2019

Study to Evaluate the Safety and Preliminary Efficacy of IDCT a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Intervertebral Disc Degeneration
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria: The subject must have:

  1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.
  2. Chronic lowback pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.
  3. Lowback pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.

Exclusion Criteria: The subject is excluded if he/she has:

  1. Symptomatic involvement of more than one lumbar disc.
  2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.
  3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.
  4. Evidence of dynamic instability on lumbar flexionextension radiographs.
  5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.
  6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.
  7. Clinical suspicion of facet pain as primary pain generator.
  8. Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.
  9. Patients who are deemed unsuitable for clinical study participation by the investigator.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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