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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with vertebral compression fractures | Experimental | Participants with vertebral compression fractures who have failed conservative care strategies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertebral Implant PEEK Procedure | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | Procedure duration in minutes | Day 1, at end of procedure |
| Volume of Cement Injected | volume of cement injected per level |
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Inclusion Criteria:
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
Patient has failed non-operative medical therapy as defined by one of the following definitions set forth by the American College of Radiology:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoyoshi Shigematsu, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21287 | United States | ||
| Icahn School of Medicine at Mount Sinai |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Vertebral Compression Fractures | Participants with vertebral compression fractures who have failed conservative care strategies. Vertebral Implant PEEK Procedure: 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) implant: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2024 |
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| Vertebral Implant PEEK (VIP) implant | Device | 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. |
|
|
| Day 1, at end of procedure |
| Number of Participants With Cement Leakage | Number of participants with presence of cement leakage | Day 1, at end of procedure |
| Fluoroscopy Time | Day 1, at end of procedure |
| Fluoroscopy Dose | Day 1, at end of procedure |
| Vertebral Height | percentage of vertebral height restoration | Day 1, at end of procedure |
| Visual Analogue Symptom (VAS) | Pain VAS, full range from 0-100, with higher score indicating more pain | 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. | 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 | 6 months |
| New York |
| New York |
| 10029 |
| United States |
| St. Luke's | Bethlehem | Pennsylvania | 18015 | United States |
| West Virginia | Morgantown | West Virginia | 26506 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
Participants who passed screening visit
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Vertebral Compression Fractures | Participants with vertebral compression fractures who have failed conservative care strategies. Vertebral Implant PEEK Procedure: 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) implant: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Study terminated early. | Posted | Number | events | 6 months |
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| Secondary | Procedure Duration | Procedure duration in minutes | Posted | Mean | Standard Deviation | minutes | Day 1, at end of procedure |
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| Secondary | Volume of Cement Injected | volume of cement injected per level | Posted | Mean | Standard Deviation | milliliters | Day 1, at end of procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Cement Leakage | Number of participants with presence of cement leakage | Study was terminated early. Independent imaging adjudicator was no longer available to review images due to study termination. | Posted | Count of Participants | Participants | Day 1, at end of procedure |
| ||||||||||||||||||||||||||||
| Secondary | Fluoroscopy Time | Posted | Mean | Standard Deviation | minutes | Day 1, at end of procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | Fluoroscopy Dose | Posted | Mean | Standard Deviation | mGy/cm^2 | Day 1, at end of procedure |
|
| ||||||||||||||||||||||||||||
| Secondary | Vertebral Height | percentage of vertebral height restoration | Study was terminated early. Independent imaging adjudicator was no longer available to review images due to study termination. | Posted | Mean | Standard Deviation | percentage of height restoration | Day 1, at end of procedure |
| |||||||||||||||||||||||||||
| Secondary | Visual Analogue Symptom (VAS) | Pain VAS, full range from 0-100, with higher score indicating more pain | Study terminated early. Results for participants who reached their 6 months follow up visit and provided data. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
| |||||||||||||||||||||||||||
| Secondary | 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. | Study terminated early. Results for participants who reached their 6 months follow up visit and completed questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Vertebral Compression Fractures | Participants with vertebral compression fractures who have failed conservative care strategies. Vertebral Implant PEEK Procedure: 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) implant: 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. | 1 | 21 | 4 | 21 | 4 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Facial Subcutaneous Inflammatory Reaction | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Acute on Chronic CHF Exacerbation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Severe Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Belching | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| New T11 fracture at inferior endplate | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| IgA lambda myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Worsened back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Worsened right hip pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sydney Edwards | Icahn School of Medicine at Mount Sinai | 212-241-2524 | Sydney.Edwards@mountsinai.org |
| Apr 21, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 18, 2024 | Apr 21, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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