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

NCT07561489 | Enrolling By Invitation

• 1 other identifier: OP-25-001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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; Allograft; Back Pain; Vertebral Compression Fracture

Keywords

vertebral compression fracture; fracture stability; OsteoPearl Biological Allograft

Outcome Measures

Primary Outcomes (1)

• Fracture Stability Evaluation

  The primary objective of this study is to evaluate fracture stability through longitudinal assessment of subject-reported pain following treatment with the OsteoPearl Biological Allograft. Pain intensity will be measured using the Numerical Rating Scale (NRS) for back pain.

  30 days

Secondary Outcomes (1)

• Quality of Life change over 30 days

  30 days

Interventions

Allograft BIOLOGICAL

OsteoPearl Biological Allograft

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a standard of care kyphoplasty or vertebroplasty procedure.

You may qualify if:

• Skeletally mature adult ≥ 50 years of age at the time of surgery;
• Currently in an independent living environment;
• 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;
• 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;
• NRS back pain score ≥ 7 on a 0-10 scale;
• Has central pain over the spinous process upon palpation at the planned vertebral index level;
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
• Personally signed and dated informed consent document prior to any study-related procedures indicating that the participant has been informed of all pertinent aspects of the study.

You may not qualify if:

• More than two levels with a vertebral compression fracture;
• Previous treated or untreated vertebral compression fractures;
• Uncorrectable coagulopathy;
• Previous instrumented spinal surgery;
• Significant vertebral collapse defined as \> 70% of original vertebral height, or a burst, or pedicle fracture;
• Degenerative scoliosis, defined as Cobb angle \> 20° at any level;
• Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
• Disabling back pain secondary to causes other than acute fracture;
• Inability to walk or stand prior to sustaining the vertebral compression fracture;
• Active systemic or local infection;
• Known history of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia or osteoporosis;
• Morbid obesity defined as a body mass index \> 40 kg/m2;
• Active malignancy. A participant with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
• Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
• Currently involved in study of another investigational product that may affect outcome;

Sponsors & Collaborators

• Lenoss Medical: lead

Study Sites (1)

Atlas Surgery Center

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)