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Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

NCT06270173•Wiltrom Co., Ltd.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (4)

Klinikum Friedrichshafen

Friedrichshafen, Baden-Wurttemberg, Germany

University Hospital Mannheim

Mannheim, Baden-Wurttemberg, Germany

Johann Wolfgang Goethe University Frankfurt/Main

Frankfurt am Main, Hesse, Germany

Krankenaus Mechernich

Mechernich, North Rhine-Westphalia, Germany

Key Dates

Start Date

February 16, 2024

Primary Completion Date

December 31, 2025

Completion Date

February 28, 2026

Last Updated

January 22, 2025

Enrollment

ACTUAL participants

Conditions

Osteoporotic Vertebral Compression Fractures

Interventions

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

DEVICE

Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment

NCT06261242

Osteoporotic Vertebral Compression Fractures

View study

NOT_YET_RECRUITINGNA

Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients

NCT07024095

Osteoporotic Vertebral Compression FracturesRestrictive Pulmonary Disorders+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment

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