Status:
COMPLETED
The Use of PRP and BMC in Patients With Internal Disc Disruption Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption
Lead Sponsor:
Annu Navani
Collaborating Sponsors:
Andrews Research & Education Foundation
Conditions:
Internal Disc Disruption
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 Plas...
Detailed Description
This multi-center randomized controlled pilot trial will be the first to evaluate the response of PRP and BMC for discogenic pain by direct comparison. The investigators propose to incorporate a cross...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04102761
Start Date
March 27 2018
End Date
December 31 2020
Last Update
August 9 2021
Active Locations (4)
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1
Alex Hames
Campbell, California, United States, 95008
2
The Orthohealing Center
Los Angeles, California, United States, 90025
3
Texas Spine and Joint Hospital
Tyler, Texas, United States, 75701
4
Nexus Pain Care
Provo, Utah, United States, 84604