Lumbar Intradiscal Platelet-Rich Plasma Injections-A Multicenter, Prospective Study in Patients with Internal Disc Disruption

August 01, 2016

Institutional Review Board, Hospital for Special Surgery

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Principal Investigator

Gregory Lutz, MD

Co-Investigators

Jennifer Solomon, MD
Richard Herzog, MD
Jonathan Kirschner, MD
Christopher Lutz, MD
Julian Harrison
Kwadwo Boachie-Adjei
 

 

Summary

This is a multicenter prospective cohort study on intradiscal platelet rich plasma injections as treatment for discogenic low back pain. All participants will receive the study treatment. 10-12 study participants will be enrolled at Hospital for Special Surgery and a total of 70 participants are expected to be enrolled across all study sites. Participants will be asked to complete pain and function questionnaires at 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after their injections. Additionally, participants will undergo follow-up MRIs at 6 months after their injections.

Inclusion/Exclusion Criteria

Inclusion criteria:

•  A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without 
      protrusions < 3mm
•  Age greater than 18 and less than 60 years
•  Maintained intervertebral disc heights of at least 50%
•  High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR
      MRI
•  Pain that is unresponsive to conservative treatment measures (oral medication, epidural steroid
      injections, physical therapy)
•  Pain persisting for an extended period of time (i.e., at least 3 months)
•  Pain relieved transiently with an epidural injection of anesthetic and steroid or documentation of
      a painful Grade 3 or 4 annular fissure on discography (Modified Dallas Discogram Classification)
•  No evidence of contraindications to undergo procedure such as pregnancy, active infection,
      bleeding disorder, or metastatic cancer

 
Exclusion criteria:

•  Spinal Deformity (Scoliosis >20 degrees, Spondylolysis, Spondylolisthesis)
•  Disc extrusions, sequestered fragments, severe thecal sac compression, or severe disc
      degeneration on MRI
•  No transient relief of pain after a diagnostic epidural injection and/or lack of concordant 
      pain/annular disruption on discography
•  Presence of a Grade V annular fissure on discography
•  Multi-level disease (> 2 levels of involvement)
•  Prior lumbar surgery or intradiscal procedure (ie.IDET, Nucleoplasty)
   

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