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

NCT05337696 | Terminated DMC FDA Device

• 1 other identifier: STUDY-21-01269
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Vertebral Compression Fractures; Osteoporotic Vertebral Compression Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Procedure duration

  Day 1, at end of procedure

• Volume of cement injected

  Day 1, at end of procedure

• Cement leakage

  Day 1, at end of procedure

• Fluoroscopy time

  Day 1, at end of procedure

• Fluoroscopy dose

  Day 1, at end of procedure

Study Arms (1)

Participants with vertebral compression fractures

EXPERIMENTAL

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

Procedure: Vertebral Implant PEEK Procedure; Device: Vertebral Implant PEEK (VIP) implant

Interventions

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.

Also known as: Vertebral Implant, VIP

Participants with vertebral compression fractures

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.

Also known as: V-STRUT©

Participants with vertebral compression fractures

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• ASA \< 4

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (4)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

St. Luke's

Bethlehem, Pennsylvania, 18015, United States

Location

West Virginia

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Tomoyoshi Shigematsu, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurosurgery

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 20, 2022
• Study Start: May 10, 2022
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)