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

This is an interventional treatment trial for Degeneration of Lumbar Intervertebral Disc Read More

Inclusion Criteria:

1. 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:

   1. Instability (≥ 3 mm translation or ≥ 5° angulation); or
   2. MRI confirmation of Modic Type 1 or Type 2 changes; or
   3. High intensity zones in the disc space.
2. Has one or two motion segment(s) to be fused between L2 and S1;
3. Skeletally mature adult, at least 18 years of age at the time of surgery;
4. Oswestry Low Back Pain Disability Questionnaire score ≥ 30 (out of 100);
5. Has completed at least 6 months of conservative therapy, which may include physical therapy, bracing, systemic or injected medications;
6. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
7. 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:

1. Three or more motion segments to be fused;
2. Degenerative scoliosis, defined as Cobb angle > 10° at any level in lumbar spine;
3. Has had a previous interbody fusion or posterolateral fusion attempt at any level of the lumbar spine;
4. Active systemic or local infection;
5. Known or documented history of communicable disease, including AIDS and HIV;
6. Active Hepatitis (receiving medical treatment within two years);
7. 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;
8. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
9. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
10. 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.
11. Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
12. 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;
13. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
14. Pregnant or planning to become pregnant during study period;
15. Involved in study of another investigational product that may affect outcome;
16. History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
17. Patients who are incarcerated.