Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures

November 4, 2026 updated by: Wiltrom Co., Ltd.

A Prospective, Multicenter, Open-Label, Post-Market Study to Evaluate The Effectiveness and Safety of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment

The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, multicenter, open-label, single-arm, PMCF study. The sample size for this study will be 50 patients. Eligible patients will be treated with Tripod-Fix on Day 0 and will be followed for a total of 12 months.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Friedrichshafen, Baden-Wurttemberg, Germany, 88048
        • Klinikum Friedrichshafen
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • University Hospital Mannheim
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • Johann Wolfgang Goethe University Frankfurt/Main
    • North Rhine-Westphalia
      • Mechernich, North Rhine-Westphalia, Germany, 53894
        • Krankenaus Mechernich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form prior to any study procedures

  2. Stated willingness to comply with all study procedures and availability for the duration of the study

  3. Skeletally mature males and females

  4. 1 painful VCF which meets all of the following criteria:

    1. Fracture due to diagnosed or presumed underlying osteoporosis (T-score < -2.5 points)
    2. VCF between T6 and L5
    3. VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline.
    4. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).

  5. Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.

Exclusion Criteria:

Tripod-Fix is not indicated for any other application other than that for which it is designed. contraindications for Tripod-Fix include, but are not limited to: .

  1. Patient presenting a loss of vertebral height >50% compared to estimated pre-fracture height
  2. Sclerotic fracture
  3. Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
  4. Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
  5. Active infection (systemic or in the target vertebra)
  6. Patient suffering from a severe or uncontrolled systemic disease
  7. Patient presenting a pathological fracture with the presence of a mass within the spinal canal
  8. Patient presenting neurological damage caused by vertebral fracture
  9. Patient pregnant or likely to be so or breastfeeding
  10. Patient vertebral anatomy not compatible with the size of the implant or instrumentation
  11. Fracture geometry making the insertion of the implant impossible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

Tripod-Fix will be used to treat osteoporotic vertebral compression fractures.
Device: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)

The Tripod-Fix is a permanent implant used for vertebral augmentation in patients with osteoporotic vertebral compression fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with study success
Time Frame: 12 months post-procedure

Study success is defined as follows:

  1. The reduction of Visual Analogue Scale (VAS) score > 20 mm at the 12 month follow up visit compared to baseline as measured by the 100-mm VAS measurement, AND
  2. Maintenance or improvement in function at the 12 month follow up visit compared to baseline as measured by the 100-point Oswestry Disability Index (ODI) AND,
  3. Absence of device-related serious adverse events.
12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wiltrom Co., Ltd.

Collaborators

Avania

Investigators

  • Study Director: Te-Yang Tsai, Wiltrom Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Actual)

June 30, 2026

Study Completion (Actual)

September 28, 2026

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TWM-C-2202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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