Internal Disc Disruption Clinical Trial
Official title:
Platelet Rich Plasma and Bone Marrow Aspirate for Lumbar Intradiscal Injections: A Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption
Verified date | August 2021 |
Source | Comprehensive Spine & Sports Center, Campbell, CA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 45 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Alex Hames | Campbell | California |
United States | The Orthohealing Center | Los Angeles | California |
United States | Nexus Pain Care | Provo | Utah |
United States | Texas Spine and Joint Hospital | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Annu Navani | Andrews Research & Education Foundation |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Worsening of Disc Pathology with Injection of Biologics | Pre and post op discs will be examined and compared for worsening pathology. | 24 weeks post procedure | |
Primary | Improvement in Disc Pain with Injection of Biologics | Pre and post op Pain will be measured and compared by Numeric Rating Scale (NRS) Numeric Pain Rating Scale (NRS): Measured from 0-10, 0 minimum score (better outcome) and 10 maximum score (worse outcome) Oswestry Low back disability (ODS): Measured from 0-50, 0 minimum score and 10 maximum score. The numbers are then calculated into percentages between 0% (minimum disability- better outcome)-100% (maximum disability- worse outcome) NASS Patient satisfaction Index (NASS): Measured from 0-4, 0 (better outcome) and 4 (worse outcome) | 24 weeks post procedure | |
Primary | Improvement in Function in Patients with Injection of Biologics | Pre and post op function will be measured and compared by Oswestry Disability Index (ODI) | 24 weeks post procedure | |
Secondary | Patient Satisfaction | Patient satisfaction will be measured by the modified North American Spine Surgery (NASS) Outcome Questionnaire | Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. | |
Secondary | Hospitalization | Hospitalization will be measured by patient's self report. | Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. | |
Secondary | Spine Surgery | Spine Surgery will be measured by patient's self report. | Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. | |
Secondary | Medications | Medications will be measured by patient's self report. | Pre injection, 1 month post op, 3 months post op, 6 months post op, 1 year. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01011816 -
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
|
Phase 3 |