The Biological Allograft Chain Tissue Implant & Associated Manual Surgical Instrumentation: A Prospective, Post-Market Study

• Skeletally mature adult ≥ 50 years of age at the time of surgery;

• Currently in an independent living environment;

• 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;

• 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;

• VAS back pain score ≥ 70 mm on a 100 mm scale;

• Has central pain over the spinous process upon palpation at the planned vertebral index level;

• Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)

• 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.