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

NCT06261242 | Active Not Recruiting

• 1 other identifier: TWM-C-2201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures.

Conditions

Osteoporotic Vertebral Compression Fractures

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with study success

  To evaluate the safety and effectiveness of the Tripod-Fix with treatment success defined as a subject must meet all the components of primary composite endpoint: 1. The reduction of Visual Analogue Scale (VAS) score \> 20 mm at the 12th month from the Baseline as measured by the 100-mm VAS measurement, AND 2. Maintenance or improvement in function at the 12th month from the Baseline as measured by the 100-point Oswestry Disability Index (ODI), AND 3. Absence of device-related serious adverse events, defined as the following events with the evidence in radiological parameters: device-related adverse events (device migration, recollapse, protrusion), or symptomatic cement extravasation requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation.

  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: 50 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.
• Male or female with at least 50 years of age.
• painful VCF which meet all of the following criteria:
• Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points).
• VCF between T7 and L4.
• Fracture age \< 3 months.
• VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration of at least 15% but not more than 40% 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.
• Patient has failed conservative medical therapy, complementary and alternative medicine, defined as either having a VAS back pain score of ≥ 50 mm at 6 weeks after initiation of fracture care or a VAS back pain score of ≥ 70 mm at 2 weeks after initiation of fracture care. If patients with pain ≥ 70 mm at baseline continued to deteriorate as demonstrated by increasing VAS score and/or progressive vertebral collapse, treatment might be initiated after 1 week of conservative care.
• Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.
• Patient has an ODI score of ≥ 30/100.

You may not qualify if:

• Target VCF due to high-energy trauma or underlying/suspected tumor.
• Target VCF is diagnosed as an osteonecrosis.
• Segmental kyphosis of target vertebral compression \> 30°.
• Any prior surgical treatment for a VCF or other surgical procedure on the target vertebral body or adjacent level.
• The patient has uncontrolled systemic diabetes (A1c \> 10) and /or uncontrolled hypertension (patient requiring 3 or more anti-hypertensive drugs).
• Pre-existing or clinically unstable neurologic deficit.
• Spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
• Any physical exam evidence of myelopathy, radiculopathy, or coagulopathy.
• Disabling back pain due to causes other than acute fracture, or any other condition that requires daily narcotic medication, such as clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis).
• Patient not able to walk without assistance prior to fracture.
• Any radiographic evidence of cortical disruption, burst fractures and pedicle fracture.
• Translation \> 4 mm or Spondylolisthesis \> Grade 1 at target vertebral body.
• Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.).
• In the investigator's opinion, a patient with any other medical illness or condition which may not be suitable to participate in the study, including but not limited to: A medical contraindication to spinal surgery and/or general anesthesia, such as Patients on chronic anti-coagulation. (Patients stop the treatment 8 days before surgery with a threshold for normal being INR \< 1.1 and platelets \> 100,000 are not limited to this.)
• Prior history of intolerance or allergic reaction to titanium and/or one of the components of the PMMA cement.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital Department of Orthopedics

Tainan, 704, Taiwan

Location

Study Officials

• Cheng-Li Lin

  NCKUH Department of Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Spinal Division/Associate Professor

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: June 16, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)