Lenoss Medical
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 inclusio…
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…
OsteoPearl Biological Allograft
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