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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07561489 on ClinicalTrials.gov