Clinical Trial

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

Study acronym: PEARL ONE
Enrolling by Invitation
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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.
Trial Details
NCT Number NCT07561489
Lead Sponsor Lenoss Medical
Conditions Kyphoplasty, Vertebroplasty, Vertebral Compression Fracture, Allograft, Back Pain
Enrollment 25 participants
Start Date 2026-03-25
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-01