Biological Allograft Chain Tissue Implant

This is an interventional treatment trial for Vertebral Body Compression Fracture(s) Read More

Inclusion Criteria:

1. Skeletally mature adult ≥ 50 years of age at the time of surgery;
2. Currently in an independent living environment;
3. One- or two- level, acute (within six weeks of injury), thoracic or lumbar (T6-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI/CT;
4. Adequate vertebral body height and geometry for insertion of the access instruments, as determined by the investigator and suitable candidate for standard kyphoplasty or vertebroplasty procedure;
5. VAS back pain score ≥ 70 mm on a 100 mm scale;
6. Has central pain over the spinous process upon palpation at the planned vertebral index level;
7. Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)
8. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
9. 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. More than two levels with a vertebral compression fracture;
2. Previous treated or untreated vertebral compression fracture at the to be treated level(s);
3. Uncorrectable coagulopathy;
4. Previous instrumented spinal surgery;
5. Significant vertebral collapse defined as > 70% of original vertebral height, or a burst, or pedicle fracture;
6. Degenerative scoliosis, defined as Cobb angle > 20° at any level;
7. Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
8. Disabling back pain secondary to causes other than acute fracture;
9. Inability to walk or stand prior to sustaining the vertebral compression fracture;
10. Active systemic or local infection;
11. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
12. Morbid obesity defined as a body mass index > 40 kg/m2;
13. Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
14. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
15. Currently 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. Pregnant or planning to become pregnant during the study period;
18. Involved in active spinal litigation;
19. Involved in a workers compensation case;
20. Prisoner or ward of the state;
21. Unable to undergo a MRI/CT procedure.