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

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

The primary objective of this observational study is to evaluate fracture stability through longitudinal assessment of subject-reported pain following treatment with the OsteoPearl Biological Allograft in men and women aged ≥50 years.

The primary research question is:

Does treatment with the OsteoPearl Biological Allograft reduce pain in men and women aged ≥50 years undergoing vertebral compression fracture procedures? Participants who are already undergoing kyphoplasty or vertebroplasty as part of standard clinical care for vertebral compression fracture will complete a pain questionnaire over a 30-day follow-up period.

This is a prospective, observational study designed to assess fracture stability through changes in subject-reported pain following treatment with the OsteoPearl Biological Allograft in patients undergoing vertebral compression fracture procedures.

In addition to the primary assessment of pain, a secondary objective is to evaluate changes in quality of life over a 30-day period, as measured by subject-reported outcomes using the Oswestry Disability Index (ODI) questionnaire.

Participants will undergo standard-of-care kyphoplasty or vertebroplasty procedures. Individuals who meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study. No investigational procedures or interventions will be introduced as part of this observational study.

Study data will be collected at baseline (pre-procedure), during the post-surgical period through hospital discharge, and at follow-up time points of Day 3, Day 7, and Day 30 post-procedure. Data collected through the Day 30 assessment will be used to evaluate outcomes associated with treatment using the OsteoPearl Biological Allograft.

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 twelve weeks of injury), thoracic or lumbar (T5-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI;
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. NRS back pain score ≥ 7 on a 0-10 scale;
6. Has central pain over the spinous process upon palpation at the planned vertebral index level;
7. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
8. 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:

1. More than two levels with a vertebral compression fracture;
2. Previous treated or untreated vertebral compression fractures;
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 other than osteopenia or osteoporosis;
12. Morbid obesity defined as a body mass index > 40 kg/m2;
13. Active malignancy. A participant 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;
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.