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

NCT05337696 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-08

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Tomoyoshi Shigematsu, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2025-03-07
Completion
2025-03-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05337696 on ClinicalTrials.gov