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

Last updated: January 20, 2025
Sponsor: Wiltrom Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)

Clinical Study ID

NCT06270173
TWM-C-2202
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 theduration of the study

  3. Skeletally mature males and females

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

  5. Fracture due to diagnosed or presumed underlying osteoporosis (T-score < -2.5points)

  6. VCF between T6 and L5

  7. VCF shows loss of height in the anterior, mid or posterior third of thevertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline.

  8. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).

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

Exclusion

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 estimatedpre-fracture height

  2. Sclerotic fracture

  3. Patient with a prior history of intolerance or of allergic reaction to titaniumand/or one of the components of the PMMA cement

  4. Patient suffering from irreversible coagulopathy or undergoing anticoagulanttreatment 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 thespinal 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 orinstrumentation

  11. Fracture geometry making the insertion of the implant impossible

Study Design

Total Participants: 53
Treatment Group(s): 1
Primary Treatment: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)
Phase:
Study Start date:
February 16, 2024
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Klinikum Friedrichshafen

    Friedrichshafen, Baden-Württemberg 88048
    Germany

    Site Not Available

  • University Hospital Mannheim

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Johann Wolfgang Goethe University Frankfurt/Main

    Frankfurt am Main, Hesse 60596
    Germany

    Site Not Available

  • Krankenaus Mechernich

    Mechernich, North-Rhine-Westphalia 53894
    Germany

    Site Not Available

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