Clinical trial NCT05337696: Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
Official title: Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vertebral Compression Fractures
Osteoporotic Vertebral Compression Fractures
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 50
* Osteoporotic compression fractures of the thoracolumbar spine (T9 -L5)
* Fracture age of ≤ 8 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
* Appropriate pedicle diameter to receive 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 pedicles or 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
* Any radiographic evidence of pedicle fracture visible on pre-operative imaging
* 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

Primary outcomes:
measure: Number of adverse events
timeFrame: End of study at 18 months
Secondary outcomes:
measure: Procedure duration
timeFrame: Day 1, at end of procedure
measure: Volume of cement injected
timeFrame: Day 1, at end of procedure
measure: Cement leakage
timeFrame: Day 1, at end of procedure
measure: Fluoroscopy time
timeFrame: Day 1, at end of procedure
measure: Fluoroscopy dose
timeFrame: Day 1, at end of procedure
measure: Vertebral Height
timeFrame: 6 months
measure: Visual Analogue Symptom (VAS)
timeFrame: 6 months
measure: The Oswestry Disability Index
timeFrame: 6 months
measure: Lost to follow up rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Bethlehem
country: United States
facility: St. Luke's
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia
state: West Virginia
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Reade De Leacy, MD
role: PRINCIPAL_INVESTIGATOR
References: