The Use of PRP and BMC in Patients With Internal Disc Disruption Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption

Completed · Not applicable

Conditions studied: Internal Disc Disruption

In brief

The condition being studied is chronic low back or leg pain in patients with internal disc disruption (IDD). The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).

Key facts

Study ID

NCT04102761

Run by

Annu Navani

People needed

45

Starts

2018-03-27

Expected to finish

2020-12-31

Last updated by the study team

2021-08-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without contained protrusions
• Age greater than 18 and less than 70 years
• Maintained intervertebral disc heights of at least 50%
• Pain not generated from facet joints, sacro-iliac joints or any pathology other than discogenic origin.
• Pain is not responsive to conservative treatment measures (oral medications, epidural steroid injections, physical therapy)
• Pain persists for an extended period of time (i.e., at least 3 months)
• High intensity zone (HIZ) in annular fissure detected on T2 or STIR MRI, degenerated discs or contained disc protrusions.
• No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
• English speaking

You may not qualify if…

• Disc extrusions, disc sequestrations, severe spinal stenosis, or severe disc degeneration with grade 5 Pfirmann index or with Modic 3 level change.
• Patient refusal
• Presence of a known bleeding disorder
• Pregnancy
• Systemic or local infection
• Presence of an unstable medical or psychiatric condition
• Prior intradiscal procedure (ie. IDET, Nucleoplasty)
• Inaccessibility to discs such as fusion
• Non-English speaking
• Prior fusion surgery

Where it is running

• Alex Hames — Campbell, California, United States
• The Orthohealing Center — Los Angeles, California, United States
• Texas Spine and Joint Hospital — Tyler, Texas, United States
• Nexus Pain Care — Provo, Utah, United States

Full record on ClinicalTrials.gov

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