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

Part of paid clinical trials in Williamsville, New York.

Sponsor
Lenoss Medical
Study ID
NCT07561489
Status
Enrolling By Invitation

Conditions

  • Allograft
  • Back Pain
  • Kyphoplasty
  • Vertebral Compression Fracture
  • Vertebroplasty

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allograft — BIOLOGICAL
    OsteoPearl Biological Allograft

Study Details

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.

Key Dates

Start date
Mar 25, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
25 participants (estimated)

Primary Outcome Measure

Fracture Stability Evaluation [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Atlas Surgery CenterWilliamsvilleNew York14221-

Find similar trials in Williamsville, NY

By research site
Atlas Surgery Center· Williamsville, NY

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