Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain

Inclusion Criteria

• •Able to provide an English written Informed Consent
• •Age 18 to 60 years inclusive
• •Male or female
• •Body mass index \<35
• •Pfirrmann Grade \[3-6\]
• •Radiographic confirmation by MRI/X-ray of:
• •1. translational instability defined as ≤5 mm, or
• •2. angular instability defined as ≤5°
• •Back pain (with or without radicular leg pain) measured by:
• •1. ODI of at least 40%, and
• •2. VASPI of at least 40mm
• •Pathologic level between L1 and S1
• •1 or 2 vertebral level involvement that has been evaluated for at least 6 months and treated with conservative care
• •Symptomatic back pain attributable to intervertebral disc for a minimum of 6 months
• •No previous surgical treatment at the disc level(s) being considered
• •Psychosocially, mentally and physically able to fully comply with this protocol, and follow-up schedule
• •Ability to undergo allograft transplantation
• •Life expectancy \>2 years
• •No contraindications to MRI
• •No history of malignancy (basal cell carcinoma) or chronic infectious disease (e.g. HIV, Hepatitis)
• •Agree to use appropriate contraception; not planning on becoming pregnant for 24 months after treatment
• •Patient disc for transplant confirmed by inter-discal pressure measurement, or disc-imaging study.
• •No signs or symptoms of infection
• •No chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs prior to treatment