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Research

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

IRB Number: 2015-716
(trial not enrolling new patients)

Institutional Review Board, Hospital for Special Surgery

August 01, 2016

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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For further information, see Understanding Clinical Trials.

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)
     

Contact Information

Nicole Hurwitz, BS
HurwitzN@hss.edu
212.774.7386