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

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: Recruiting
• Conditions: Osteoporotic Vertebral Compression Fractures
• Intervention / Treatment: Device: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)

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 (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Tseng; Phone Number: 222 +8863-6107168; Email: yctseng@wiltrom.com.tw

Study Locations

• Germany
  • Baden-Württemberg
    • Friedrichshafen, Baden-Württemberg, Germany, 88048
      • Not yet recruiting
      • Klinikum Friedrichshafen
      • Principal Investigator: Ludwig Oberkircher, Prof Dr med
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Not yet recruiting
      • University Hospital Mannheim
      • Principal Investigator: Frederic Bludau, PD Dr med
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60596
      • Not yet recruiting
      • Johann Wolfgang Goethe University Frankfurt/Main
      • Principal Investigator: Thomas Vogl, Prof Dr med
  • North-Rhine-Westphalia
    • Mechernich, North-Rhine-Westphalia, Germany, 53894
      • Recruiting
      • Krankenaus Mechernich
      • Principal Investigator: Robert Pflugmacher, Prof Dr med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

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: 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	Study success is defined as follows: 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; 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,; Absence of device-related serious adverse events.	12 months post-procedure

Collaborators and Investigators

• Sponsor: Wiltrom Co., Ltd.
• Collaborators: Maxis Medical GmbH
• Investigators: Study Director: Te-Yang Tsai, Wiltrom Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 16, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression
• 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