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

NCT06270173 | Active Not Recruiting

• 1 other identifier: TWM-C-2202
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Osteoporotic Vertebral Compression Fractures

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with study success

  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

Study Arms (1)

Intervention

EXPERIMENTAL

Tripod-Fix will be used to treat osteoporotic vertebral compression fractures.

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

Interventions

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

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form prior to any study procedures
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Skeletally mature males and females
• painful VCF which meets all of the following criteria:
• Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points)
• VCF between T6 and L5
• 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.
• The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).
• Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.

You may not qualify if:

• 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: .
• Patient presenting a loss of vertebral height \>50% compared to estimated pre-fracture height
• Sclerotic fracture
• Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
• Active infection (systemic or in the target vertebra)
• Patient suffering from a severe or uncontrolled systemic disease
• Patient presenting a pathological fracture with the presence of a mass within the spinal canal
• Patient presenting neurological damage caused by vertebral fracture
• Patient pregnant or likely to be so or breastfeeding
• Patient vertebral anatomy not compatible with the size of the implant or instrumentation
• Fracture geometry making the insertion of the implant impossible

Sponsors & Collaborators

• Wiltrom Co., Ltd.: lead
• Avania: collaborator

Study Sites (4)

Klinikum Friedrichshafen

Friedrichshafen, Baden-Wurttemberg, 88048, Germany

Location

University Hospital Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Johann Wolfgang Goethe University Frankfurt/Main

Frankfurt am Main, Hesse, 60596, Germany

Location

Krankenaus Mechernich

Mechernich, North Rhine-Westphalia, 53894, Germany

Location

Study Officials

• Te-Yang Tsai

  Wiltrom Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: February 16, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

DE (4)