Vertebral Compression FracturesRECONSTRUCTNCT05337696
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
A study testing Vertebral Implant PEEK Procedure and Vertebral Implant PEEK (VIP) implant in people with Vertebral Compression Fractures and Osteoporotic Vertebral Compression Fractures, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
Trial summary
The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (<8week) vertebral compression fractures who have failed conservative care… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Compression Fractures, Osteoporotic Vertebral Compression Fractures
- What is being tested?
- Vertebral Implant PEEK Procedure and Vertebral Implant PEEK (VIP) implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 May 2022to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 50
- Osteoporotic compression fractures of the thoracolumbar spine (T1 -L5)
- Up to three levels can be fractured and treated, but at least one of the three need to be treated with V-STRUT; the level(s) to be treated with study device is at the discretion of the enrolling investigator
- Fracture age of ≤ 12 weeks as indicated by onset of pain or known antecedent traumatic event with corresponding evidence of acuity on MRI (T1 and STIR sequences) or radioisotope bone scan
- ODI ≥ 30/100 at screening visit and VAS ≥ 60 at screening visit
- Failure of conservative management strategies for compression fractures resulting in inadequately controlled pain and/or patient immobility
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- Patient has failed non-operative medical therapy as defined by one of the following definitions set forth by the American College of Radiology:
- For a patient rendered nonambulatory as a result of pain from a VCF, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy; or
- For a patient with sufficient pain from a VCF such that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy; or
- For a patient with pain from a VCF, unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level.
- Magerl classification A1.1, A1.2, A1.3, A2.1, A2.2 and A3.1 type fractures: pediculosomatic junction fractures and other fractures involving vertebral pedicles
- Appropriate pedicle diameter to receive 4.5mm, 5.5mm diameter or 6.5mm diameter implants
- ASA < 4
Who cannot join
- Patient clearly improving on conservative treatment
- Any contra-indication or allergy to implant material or cement
- Systemic infection or infection located in the spine
- Any medical condition including but not limited to anemia, coagulation disorders, fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would preclude the patient from having surgery or would impede the benefit of surgery
- Neurologic signs or symptoms related to the fracture or the impeding pathological fracture
- Any previous surgical treatment (material or cement) in the targeted vertebra
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- Less than one third of the original vertebral body height remaining
- Unstable fractures or neoplasms with posterior involvement
- Damages of the posterior wall
- Sclerotic cancellous bone
- Pedicles not large enough to accept V-STRUT© instrumentation and implants
- Pregnancy(women of childbearing potential must have a negative pregnancy test to participate)
- Pre-existing or clinically unstable neurologic deficit
- Spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated
- Any physical exam evidence of myelopathy or radiculopathy
- Pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
- Bedbound prior to incident fracture
- Spondylolisthesis >Grade 1 at target VB
- Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.)
- A medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy and/or taking warfarin (Coumadin) or other anticoagulant or anti-aggregate (anti-platelet agents) on regular basis for coagulopathy (with a threshold for normal being INR≤1.5, PTT within lab normal range, and platelet count > 100,000)
- Disabling backpain due to causes other than acute fracture
- Severe cardiopulmonary deficiencies
- Any evidence of alcohol or drug abuse
- Uncontrolled psychiatric illness or severe dementia
- Involved in medical litigation including workers' compensation
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins
Baltimore, Maryland, 21287
St. Luke's
Bethlehem, Pennsylvania, 18015
West Virginia
Morgantown, West Virginia, 26506
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (<8week) vertebral compression fractures who have failed conservative care strategies.
Read the detailed description
Vertebral compression fractures affect an estimated 1.4 million patients in the world annually and incidence rates rise exponentially with age, especially in women. Outcomes following non-interventional management of these injuries are generally poor, largely as a consequence of opioid requirements, prolonged immobilization, and bedrest. As a result, interventional techniques such as balloon kyphoplasty and vertebroplasty with or without implantable devices are currently regarded as the standard of care for select patients with acute painful osteoporotic compression fractures. These procedures relieve fracture pain by stabilizing the fracture site using cement.
Alternative interventional techniques include percutaneous vertebral augmentation, which combine cement injection with implantable devices, such as the SpineJack® and KIVA® devices. The RECONSTRUCT study will build on the outcomes of the SAKOS and KAST clinical trails that evaluated the SpineJack® and KIVA® devices, respectively.
The Vertebral Implant PEEK (VIP) implant (V-STRUT© manufactured by Hyprevention) has undergone both clinical and pre-clinical testing. Static and dynamic bending of the implant has been evaluated to demonstrate that the product is capable of supporting in-situ loading, and increase fracture load and energy to fracture.
A total of 30 eligible subjects with a diagnosis of osteoporotic fractures of the thoracolumbar spine, as confirmed by MRI scan, and who are treated with the Vertebral Implant PEEK (VIP) device will be asked to join the study. No placebo or control will be utilized during this study.
RECONSTRUCT has been designed with the intention of achieving two goals: 1) to inform the design of larger controlled clinical trials in the future and 2) to assess the safety of the study device within the patient sample.
- Being tested
- Vertebral Implant PEEK Procedure, Vertebral Implant PEEK (VIP) implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral Implant PEEK ProcedureProcedure or surgery
Also called Vertebral Implant, VIP
Vertebral Implant PEEK (VIP) procedure is a minimally invasive/percutaneous vertebral augmentation (PVA), image guided procedure. Two VIP devices are implanted in each to be treated vertebra. A cavity is drilled allowing the introduction of the implant posteriorly through the pedicle and the vertebral body upto the anterior wall. A part of the implant is embedded into the pedicle, thus providing posterior support. The other part of the device, located in the vertebral body, presents a central canula and lateral perforations, which allow acrylic bone cement diffusion, filling of the vertebral body, filling and fixing the implant, and supporting of the upper endplate. The combination of the implant and the cement allows the treatment of vertebral fractures.
Vertebral Implant PEEK (VIP) implantDevice
Also called V-STRUT©
The study device is V-STRUT© Vertebral Implant manufactured by Hyprevention (VIP -Vertebral Implant PEEK), FDA cleared under K191709, indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with PMMA bone cement.
| Study group | Role | What they receive |
|---|---|---|
| Participants with vertebral compression fractures | Experimental | Participants with vertebral compression fractures who have failed conservative care strategies. Receives: Procedure: Vertebral Implant PEEK Procedure; Device: Vertebral Implant PEEK (VIP) implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device Related Adverse Events
Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: 6 months
Secondary outcomes (9)
Procedure Duration
Procedure duration in minutes
Measured: Day 1, at end of procedure
Volume of Cement Injected
volume of cement injected per level
Measured: Day 1, at end of procedure
Number of Participants With Cement Leakage
Number of participants with presence of cement leakage
Measured: Day 1, at end of procedure
Fluoroscopy Time
Measured: Day 1, at end of procedure
Fluoroscopy Dose
Measured: Day 1, at end of procedure
Vertebral Height
percentage of vertebral height restoration
Measured: Day 1, at end of procedure
Visual Analogue Symptom (VAS)
Pain VAS, full range from 0-100, with higher score indicating more pain
Measured: 6 months
The Oswestry Disability Index
The Oswestry Disability Index is a Low Back Pain Disability Questionnaire frequently used to assess function and very often report in the literature. Full range from 0-100, with higher score indicating more severe disability.
Measured: 6 months
Number of Participants Lost to Follow up
Study will evaluate the lost to follow up rate to determine statistical methodology and enrollment requirements for any follow up pivotal study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start10 May 2022
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Why it stopped: financial constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vertebral Compression FracturesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomoyoshi Shigematsu, Icahn School of Medicine at Mount Sinai
- Investigators
- Tomoyoshi Shigematsu, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337696
- Sponsor's protocol ID
- STUDY-21-01269
- Acronym
- RECONSTRUCT
- Status last verified
- Jul 2025
- First submitted
- 26 Mar 2022
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Upon the completion of the study, Mount Sinai's data management team will clean and analysis all data in preparation of manuscript writing and publication. The intention will be to publish together between the principal investigator and the sponsor. Following publication, Mount Sinai will archive and store all associated data on it's cloud-based system
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
- ClinicalTrials.gov ID
- NCT05337696
- Acronym / sponsor ID
- RECONSTRUCT / STUDY-21-01269
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: financial constraints
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (<8week) vertebral compression fractures who have failed conservative care strategies.
Detailed description
Vertebral compression fractures affect an estimated 1.4 million patients in the world annually and incidence rates rise exponentially with age, especially in women. Outcomes following non-interventional management of these injuries are generally poor, largely as a consequence of opioid requirements, prolonged immobilization, and bedrest. As a result, interventional techniques such as balloon kyphoplasty and vertebroplasty with or without implantable devices are currently regarded as the standard of care for select patients with acute painful osteoporotic compression fractures. These procedures relieve fracture pain by stabilizing the fracture site using cement.
Alternative interventional techniques include percutaneous vertebral augmentation, which combine cement injection with implantable devices, such as the SpineJack® and KIVA® devices. The RECONSTRUCT study will build on the outcomes of the SAKOS and KAST clinical trails that evaluated the SpineJack® and KIVA® devices, respectively.
The Vertebral Implant PEEK (VIP) implant (V-STRUT© manufactured by Hyprevention) has undergone both clinical and pre-clinical testing. Static and dynamic bending of the implant has been evaluated to demonstrate that the product is capable of supporting in-situ loading, and increase fracture load and energy to fracture.
A total of 30 eligible subjects with a diagnosis of osteoporotic fractures of the thoracolumbar spine, as confirmed by MRI scan, and who are treated with the Vertebral Implant PEEK (VIP) device will be asked to join the study. No placebo or control will be utilized during this study.
RECONSTRUCT has been designed with the intention of achieving two goals: 1) to inform the design of larger controlled clinical trials in the future and 2) to assess the safety of the study device within the patient sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with vertebral compression fractures | Experimental | Procedure: Vertebral Implant PEEK Procedure, Device: Vertebral Implant PEEK (VIP) implantParticipants with vertebral compression fractures who have failed conservative care strategies. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 50
- Osteoporotic compression fractures of the thoracolumbar spine (T1 -L5)
- Up to three levels can be fractured and treated, but at least one of the three need to be treated with V-STRUT; the level(s) to be treated with study device is at the discretion of the enrolling investigator
- Fracture age of ≤ 12 weeks as indicated by onset of pain or known antecedent traumatic event with corresponding evidence of acuity on MRI (T1 and STIR sequences) or radioisotope bone scan
- ODI ≥ 30/100 at screening visit and VAS ≥ 60 at screening visit
Key exclusion criteria (25 listed)
- Patient clearly improving on conservative treatment
- Any contra-indication or allergy to implant material or cement
- Systemic infection or infection located in the spine
- Any medical condition including but not limited to anemia, coagulation disorders, fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would preclude the patient from having surgery or would impede the benefit of surgery
- Neurologic signs or symptoms related to the fracture or the impeding pathological 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 Implant PEEK ProcedureAlso: Vertebral Implant, VIPVertebral Implant PEEK (VIP) procedure is a minimally invasive/percutaneous vertebral augmentation (PVA), image guided procedure. Two VIP devices are implanted in each to be treated vertebra. A cavity is drilled allowing the introduction of the implant posteriorly through the pedicle and the vertebral body upto the anterior wall. A part of the implant is embedded into the pedicle, thus providing posterior support. The other part of the device, located in the vertebral body, presents a central canula and lateral perforations, which allow acrylic bone cement diffusion, filling of the vertebral body, filling and fixing the implant, and supporting of the upper endplate. The combination of the implant and the cement allows the treatment of vertebral fractures. | Procedure or surgery | Participants with vertebral compression fractures |
| Vertebral Implant PEEK (VIP) implantAlso: V-STRUT©The study device is V-STRUT© Vertebral Implant manufactured by Hyprevention (VIP -Vertebral Implant PEEK), FDA cleared under K191709, indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with PMMA bone cement. | Device | Participants with vertebral compression fractures |
Primary outcome
Number of Device Related Adverse Events
Time frame: 6 months
Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
9 secondary outcomes
Procedure Duration
Time frame: Day 1, at end of procedure
Volume of Cement Injected
Time frame: Day 1, at end of procedure
Number of Participants With Cement Leakage
Time frame: Day 1, at end of procedure
Fluoroscopy Time
Time frame: Day 1, at end of procedure
Fluoroscopy Dose
Time frame: Day 1, at end of procedure
Vertebral Height
Time frame: Day 1, at end of procedure
Visual Analogue Symptom (VAS)
Time frame: 6 months
The Oswestry Disability Index
Time frame: 6 months
Number of Participants Lost to Follow up
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Upon the completion of the study, Mount Sinai's data management team will clean and analysis all data in preparation of manuscript writing and publication. The intention will be to publish together between the principal investigator and the sponsor. Following publication, Mount Sinai will archive and store all associated data on it's cloud-based system
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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. This study is not recruiting at the moment.
Tomoyoshi Shigematsu, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebral Implant PEEK Procedure and Vertebral Implant PEEK (VIP) implant in people with Vertebral Compression Fractures and Osteoporotic Vertebral Compression Fractures, run by Icahn School of Medicine at Mount Sinai at 4 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 13 inclusion and 25 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: stopped early, as of the sponsor's last update on 28 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 4 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?
Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Device Related Adverse Events (time frame: 6 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 28 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.