Osteoporotic Vertebral Compression Fractures, Vertebral Compression Fractures
Conditions
Brief 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 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.
Interventions
PROCEDUREVertebral 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.
DEVICEVertebral 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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: 1. 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 2. 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 3. 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device Related Adverse Events | 6 months | Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration | Day 1, at end of procedure | Procedure duration in minutes |
| Volume of Cement Injected | Day 1, at end of procedure | volume of cement injected per level |
| Number of Participants With Cement Leakage | Day 1, at end of procedure | Number of participants with presence of cement leakage |
| Fluoroscopy Time | Day 1, at end of procedure | — |
| Fluoroscopy Dose | Day 1, at end of procedure | — |
| Vertebral Height | Day 1, at end of procedure | percentage of vertebral height restoration |
| Visual Analogue Symptom (VAS) | 6 months | Pain VAS, full range from 0-100, with higher score indicating more pain |
| The Oswestry Disability Index | 6 months | 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. |
| Number of Participants Lost to Follow up | 6 months | Study will evaluate the lost to follow up rate to determine statistical methodology and enrollment requirements for any follow up pivotal study |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTomoyoshi Shigematsu, MD
Icahn School of Medicine at Mount Sinai
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 73.95 years STANDARD_DEVIATION 11.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 21 |
| other Total, other adverse events | 4 / 21 |
| serious Total, serious adverse events | 4 / 21 |
Outcome results
None listed