Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate

Inclusion Criteria

• Has the following indication for posterolateral fusion (transverse process and facet fusion) with posterior rod and screw fixation:
• Degenerative Disc Disease (DDD), with or without stenosis. Diagnosis of DDD requires back and/or leg (radicular) pain along with:
• Instability (≥ 3 mm translation or ≥ 5° angulation); or
• MRI confirmation of Modic Type 1 or Type 2 changes; or
• High intensity zones in the disc space.
• Has one or two motion segment(s) to be fused between L2 and S1;
• Skeletally mature adult, at least 18 years of age at the time of surgery;
• Oswestry Low Back Pain Disability Questionnaire score ≥ 30 (out of 100);
• Has completed at least 6 months of conservative therapy, which may include physical therapy, bracing, systemic or injected medications;
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
• Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.

Exclusion Criteria

• Three or more motion segments to be fused;
• Degenerative scoliosis, defined as Cobb angle > 10° at any level in lumbar spine;
• Has had a previous interbody fusion or posterolateral fusion attempt at any level of the lumbar spine;
• Active systemic or local infection;
• Known or documented history of communicable disease, including AIDS and HIV;
• Active Hepatitis (receiving medical treatment within two years);
• Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
• Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
• Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
• Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a dual energy x-ray absorptiometry (DXA) bone mineral density measurement. If DXA is required, exclusion will be defined as a DXA bone density measured T score less than or equal to -1.0.
• Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
• Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
• Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
• Pregnant or planning to become pregnant during study period;
• Involved in study of another investigational product that may affect outcome;
• History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
• Patients who are incarcerated.