A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants
NCT07561489 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 25
Last updated 2026-05-01
Summary
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.
Conditions
- Kyphoplasty
- Vertebroplasty
- Vertebral Compression Fracture
- Allograft
- Back Pain
Interventions
- BIOLOGICAL
-
Allograft
OsteoPearl Biological Allograft
Sponsors & Collaborators
-
Lenoss Medical
lead INDUSTRY
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-25
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
Countries
- United States
Study Locations
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