Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant (RECONSTRUCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Vertebral Compression Fractures; Osteoporotic Vertebral Compression Fractures
• Intervention / Treatment: Procedure: Vertebral Implant PEEK Procedure; Device: Vertebral Implant PEEK (VIP) implant

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 Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sydney Edwards; Phone Number: 212 241 2524; Email: sydney.edwards@mountsinai.org
• Study Contact Backup: Name: Sukaina Davdani; Phone Number: 212 241 2524; Email: Sukaina.Davdani@mountsinai.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • Johns Hopkins
      • Contact: Majid Khan
      • Principal Investigator: Majid Khan
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Michael T Caton
      • Principal Investigator: Michael T Caton
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Recruiting
      • St. Luke's
      • Contact: Martin Oselkin
      • Principal Investigator: Martin Oselkin
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia
      • Contact: SoHyun Boo
      • Principal Investigator: SoHyun Boo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants with vertebral compression fractures; Participants with vertebral compression fractures who have failed conservative care strategies.

Procedure: 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.; Other Names: VIP; Vertebral Implant; Device: 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.; Other Names: V-STRUT©

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0	End of study at 18 months

Secondary Outcome Measures

Outcome Measure	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	Day 1, at end of procedure
Cement leakage	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	6 months
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
Lost to follow up rate	Study will evaluate the lost to follow up rate to determine statistical methodology and enrollment requirements for any follow up pivotal study	6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Reade De Leacy, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression
• Other Study ID Numbers: STUDY-21-01269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No