Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Number of Device Related Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •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
研究组 & 干预措施
Participants with vertebral compression fractures
Participants with vertebral compression fractures who have failed conservative care strategies.
干预措施: Vertebral Implant PEEK Procedure (Procedure)
Participants with vertebral compression fractures
Participants with vertebral compression fractures who have failed conservative care strategies.
干预措施: Vertebral Implant PEEK (VIP) implant (Device)
结局指标
主要结局
Number of Device Related Adverse Events
时间窗: 6 months
Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
次要结局
- The Oswestry Disability Index(6 months)
- Visual Analogue Symptom (VAS)(6 months)
- Procedure Duration(Day 1, at end of procedure)
- Volume of Cement Injected(Day 1, at end of procedure)
- Number of Participants With 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(Day 1, at end of procedure)
- Number of Participants Lost to Follow up(6 months)
研究者
Tomoyoshi Shigematsu
Assistant Professor, Neurosurgery
Icahn School of Medicine at Mount Sinai