KyphoplastyPEARL ONENCT07561489
A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants
An observational study of Kyphoplasty and Vertebroplasty, run by Lenoss Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Kyphoplasty, Vertebroplasty, Vertebral Compression Fracture
- What is being tested?
- Allograft
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a standard of care kyphoplasty or vertebroplasty procedure.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- History of psychosocial disorders that could prevent accurate completion of self-reporting assessment scales;
- Pregnant or planning to become pregnant during the study period;
- Involved in active spinal litigation;
- Involved in a workers compensation case;
- Prisoner or ward of the state;
- Unable to undergo a MRI/CT procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Allograft
- Keywords
- vertebral compression fracture, fracture stability, OsteoPearl Biological Allograft
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllograftBiological
OsteoPearl Biological Allograft
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start25 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenoss Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561489
- Sponsor's protocol ID
- OP-25-001
- Acronym
- PEARL ONE
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants
- ClinicalTrials.gov ID
- NCT07561489
- Acronym / sponsor ID
- PEARL ONE / OP-25-001
- Keywords
- vertebral compression fracture, fracture stability, OsteoPearl Biological Allograft
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Lenoss MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a standard of care kyphoplasty or vertebroplasty procedure.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllograftOsteoPearl Biological Allograft | Biological | – |
Primary outcome
Fracture Stability Evaluation
Time frame: 30 days
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.
1 secondary outcome
Quality of Life change over 30 days
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kyphoplasty and Vertebroplasty, run by Lenoss Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Stability Evaluation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.