Research

Lumbar Intradiscal Platelet Rich Plasma Injections: A Prospective, Double-blinded, Randomized Controlled Study

IRB Number: 29025

Institutional Review Board, Hospital for Special Surgery

September 16, 2009

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Principal Investigator

Gregory E. Lutz, MD

Co-Investigators

Christopher Lutz, MD
Jennifer L. Solomon, MD
Alon Terry, MD
Elizabeth LaSalle

Summary

This is a prospective, randomized controlled study investigating the utility of intradiscal platelet rich plasma injections in patients with discogenic mediated low back pain as determined by discography.  A total number of 72 pateints will be enrolled and subsequently randomized in a 2:1 ratio to receive either platelet rich plasma or additional contrast agent, respectively, into the lumbar intradiscal level that causes concordant pain at the time of a discogram procedure.  Enrollment will begin at the time of full IRB approval.  The follow-up period will last for 6 months.

Inclusion/Exclusion Criteria

Inclusion Criteria: 
 Surgical management is a viable option
 A high index of suspicion for discogenic pain, ie. painful degenerative discs
 Maintained intervertebral disc heights of at least 50%
 Pain is not responsive to conservative treatment measures
 Failed back surgery
 Pain persists for an extended period of time (i.e., at least 3 months)
 No evidence of contraindications, such as spinal stenosis

Exclusion Criteria
 Patients with a known bleeding disorder and those on anticoagulation therapy
 Pregnancy
 Systemic infection or skin infection over the puncture site
 Allergy to contrast
 Psychiatric conditions such as PTSD or schizophrenia
 Solid bone fusion that does not allow access to the disc
 Severe spinal canal compromise at the disc levels to be investigated
 Severe intervertebral disc protrusions greater than 5mm, extrusions, or sequestered fragments
 Spondylolisthesis greater than grade I and/or evidence of instability on flexion and extension radiographs of the lumbar spine

Contact Information

Elizabeth LaSalle
LaSalleE@hss.edu
212.774.7386



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