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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Back Pain; Vertebral Compression Fracture; Allograft; Kyphoplasty; Vertebroplasty
• Intervention / Treatment: Biological: Allograft

Detailed Description

This is a prospective, observational study designed to assess fracture stability through changes in subject-reported pain following treatment with the OsteoPearl Biological Allograft in patients undergoing vertebral compression fracture procedures.

In addition to the primary assessment of pain, a secondary objective is to evaluate changes in quality of life over a 30-day period, as measured by subject-reported outcomes using the Oswestry Disability Index (ODI) questionnaire.

Participants will undergo standard-of-care kyphoplasty or vertebroplasty procedures. Individuals who meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study. No investigational procedures or interventions will be introduced as part of this observational study.

Study data will be collected at baseline (pre-procedure), during the post-surgical period through hospital discharge, and at follow-up time points of Day 3, Day 7, and Day 30 post-procedure. Data collected through the Day 30 assessment will be used to evaluate outcomes associated with treatment using the OsteoPearl Biological Allograft.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

Study Locations

• United States
  • New York
    • Williamsville, New York, United States, 14221
      • Atlas Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a standard of care kyphoplasty or vertebroplasty procedure.

Description

Inclusion Criteria:

1. Skeletally mature adult ≥ 50 years of age at the time of surgery;
2. Currently in an independent living environment;
3. 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;
4. 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;
5. NRS back pain score ≥ 7 on a 0-10 scale;
6. Has central pain over the spinous process upon palpation at the planned vertebral index level;
7. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
8. 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.

Exclusion Criteria:

1. More than two levels with a vertebral compression fracture;
2. Previous treated or untreated vertebral compression fractures;
3. Uncorrectable coagulopathy;
4. Previous instrumented spinal surgery;
5. Significant vertebral collapse defined as > 70% of original vertebral height, or a burst, or pedicle fracture;
6. Degenerative scoliosis, defined as Cobb angle > 20° at any level;
7. Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
8. Disabling back pain secondary to causes other than acute fracture;
9. Inability to walk or stand prior to sustaining the vertebral compression fracture;
10. Active systemic or local infection;
11. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia or osteoporosis;
12. Morbid obesity defined as a body mass index > 40 kg/m2;
13. 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;
14. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
15. Currently involved in study of another investigational product that may affect outcome;
16. History of psychosocial disorders that could prevent accurate completion of self-reporting assessment scales;
17. Pregnant or planning to become pregnant during the study period;
18. Involved in active spinal litigation;
19. Involved in a workers compensation case;
20. Prisoner or ward of the state;
21. Unable to undergo a MRI/CT procedure.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life change over 30 days	The secondary objective is to assess changes in quality of life over a 30-day period, as measured by subject-reported outcomes using the Oswestry Disability Index (ODI) questionnaire.	30 days

Collaborators and Investigators

• Sponsor: Lenoss Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: vertebral compression fracture; fracture stability; OsteoPearl Biological Allograft
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Surgical Procedures, Operative; Transplantation; Transplantation, Homologous
• Other Study ID Numbers: OP-25-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with external researchers. This is a prospective, single-arm observational study evaluating clinical and surgical outcomes associated with OsteoPearl allograft implants at a single ambulatory surgery center (Protocol OP-25-001). The observational, minimal-risk nature of the study, the proprietary nature of the allograft device and procedural data, and the limited sample size preclude meaningful external reanalysis of individual-level data. Lenoss Medical intends to publish aggregate study findings in a peer-reviewed journal upon study completion. Summary-level results will be reported in accordance with applicable regulatory, ethical, and ICMJE publication guidelines. Requests for data access may be directed to the sponsor and will be considered on a case-by-case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No