A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants

Inclusion criteria

• ✓. Skeletally mature adult ≥ 50 years of age at the time of surgery;
• ✓. Currently in an independent living environment;
• ✓. One- or two- level, acute (within twelve weeks of injury), thoracic or lumbar (T5-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI;
• ✓. 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;
• ✓. NRS back pain score ≥ 7 on a 0-10 scale;
• ✓. Has central pain over the spinous process upon palpation at the planned vertebral index level;
• ✓. 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 participant has been informed of all pertinent aspects of the study.

Exclusion criteria