Vertebral Body Compression Fracture(s)NCT04064710
Biological Allograft Chain Tissue Implant
A study testing Vertebral Body Augmentation and Manual Surgical Instruments in people with Vertebral Body Compression Fracture(s), run by Lenoss Medical at 5 sites in United States.
Trial summary
A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Body Compression Fracture(s)
- What is being tested?
- Vertebral Body Augmentation and Manual Surgical Instruments
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Jun 2019to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
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 six weeks of injury), thoracic or lumbar (T6-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI/CT;
- 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;
- VAS back pain score ≥ 70 mm on a 100 mm scale;
- Has central pain over the spinous process upon palpation at the planned vertebral index level;
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- Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)
- 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 patient 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 fracture at the to be treated level(s);
- 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;
- Morbid obesity defined as a body mass index > 40 kg/m2;
- Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
University of Colorado Denver | Anschutz Medical Campus
Denver, Colorado, 80204
Nicola Haakonsen, 720-848-2425, Nicola.Haakonsen@cuanschutz.edu
Corey Ho, MD
- Active, not recruiting
Clinical Investigations LLC
Edmond, Oklahoma, 73013
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Brittany Hobbie, 516-693-3976, bhobbie@northwell.edu
Athos Patsalides, MD
- Recruiting
Mount Sinai
New York, New York, 10029
Sukaina Davdani, 212-241-2524, Sukaina.davdani@mountsinai.org
Reade De Leacy, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Parina Shah, 718-920-6267, parishah@montefiore.org
Allan Brook, MD
About this study
Official title: The Biological Allograft Chain Tissue Implant & Associated Manual Surgical Instrumentation: A Prospective, Post-Market Study
A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.
Read the detailed description
Vertebral compression fractures can be associated with instability and severe, persistent pain and limitation of activities. This post market study is being conducted to assess fracture stability over time.
- Conditions
- Vertebral Body Compression Fracture(s)
- Being tested
- Vertebral Body Augmentation, Manual Surgical Instruments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral Body AugmentationProcedure or surgery
Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.
Manual Surgical InstrumentsDevice
Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.
| Study group | Role | What they receive |
|---|---|---|
| Allograft Tissue | Other | Allograft tissue product for patients with painful vertebral compression fractures Receives: Procedure: Vertebral Body Augmentation; Device: Manual Surgical Instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate fracture stability assessed via subject- reported pain over time
Subject-reported pain over time using the allograft tissue will be assessed using the Visual Analog Scale (VAS) for back pain on a scale of 0mm (no pain) to 100mm (worst pain imaginable).
Measured: 12 months
Secondary outcomes (4)
Measure of Physical Disability Assessed via the Roland Morris Disability Questionnaire
The Roland Morris Disability Questionnaire is a widely used health status measure for physical disability caused by low back pain. Scores range from 0 to 24 with higher scores representing higher levels of pain-related disability.
Measured: 12 months
Measurement of Quality of Life Assessed via the EuroQol Health Outcome Instrument (EQ-5D-3L)
The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".
Measured: 12 months
Measurement of Activities of Daily Living Assessed via the Modified Tegner Activity Level Scale
The Modified Tegner Activity Level Scale is designed to measure a patient's activities of daily living, recreation, and competitive sports. The scale includes an assessment of level of activity pre- and post- injury. The scores range from 0 to 10 with a 0 representing sick leave or disability.
Measured: 12 months
Frequency of Implant Related Complications
The frequency of allograft tissue related complications will be tabulated. Intra-operative complications, surgical time, and any other significant adverse events will be summarized as safety variables. Adverse events will be tabulated by physician's assessment of seriousness, severity, expectedness, the event's causative relation to the allograft tissue or the Access and Cavity Creation instruments, and by elapsed time since surgery. Adverse events that require secondary surgical intervention (SSI) will be flagged.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start10 Jun 2019
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Body Compression Fracture(s)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenoss Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064710
- Sponsor's protocol ID
- SP-18-001
- Status last verified
- May 2021
- First submitted
- 20 Aug 2019
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biological Allograft Chain Tissue Implant & Associated Manual Surgical Instrumentation: A Prospective, Post-Market Study
- ClinicalTrials.gov ID
- NCT04064710
- Acronym / sponsor ID
- SP-18-001
- Conditions
- Vertebral Body Compression Fracture(s)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Lenoss MedicalIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Aug 2019 (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.
A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.
Detailed description
Vertebral compression fractures can be associated with instability and severe, persistent pain and limitation of activities. This post market study is being conducted to assess fracture stability over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allograft Tissue | Other | Procedure: Vertebral Body Augmentation, Device: Manual Surgical InstrumentsAllograft tissue product for patients with painful vertebral compression fractures |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 six weeks of injury), thoracic or lumbar (T6-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI/CT;
- 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;
- VAS back pain score ≥ 70 mm on a 100 mm scale;
Key exclusion criteria (21 listed)
- More than two levels with a vertebral compression fracture;
- Previous treated or untreated vertebral compression fracture at the to be treated level(s);
- 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 |
|---|---|---|
| Vertebral Body AugmentationUse allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures. | Procedure or surgery | Allograft Tissue |
| Manual Surgical InstrumentsLenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue. | Device | Allograft Tissue |
Primary outcome
Evaluate fracture stability assessed via subject- reported pain over time
Time frame: 12 months
Subject-reported pain over time using the allograft tissue will be assessed using the Visual Analog Scale (VAS) for back pain on a scale of 0mm (no pain) to 100mm (worst pain imaginable).
4 secondary outcomes
Measure of Physical Disability Assessed via the Roland Morris Disability Questionnaire
Time frame: 12 months
Measurement of Quality of Life Assessed via the EuroQol Health Outcome Instrument (EQ-5D-3L)
Time frame: 12 months
Measurement of Activities of Daily Living Assessed via the Modified Tegner Activity Level Scale
Time frame: 12 months
Frequency of Implant Related Complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebral Body Augmentation and Manual Surgical Instruments in people with Vertebral Body Compression Fracture(s), run by Lenoss Medical at 5 sites 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 9 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: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dom Messerli (484-988-0477, dom.messerli@lenoss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate fracture stability assessed via subject- reported pain over time (time frame: 12 months). 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 14 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.