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Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment | Clinical Trials | Clareo Health

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

A Study of Tripod-Fix Vertebral Body Augmentation System in Vertebral Compression Fractures Caused by Osteoporosis

NCT06261242•National Cheng-Kung University Hospital

View on ClinicalTrials.gov

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.

Detailed Description

This study is a prospective, single-center, open-label, single-arm study. This study will screen up to 12 eligible patients. Eligible patients will be treated with Tripod-Fix on the Day 1 and follow-up for 12 months. Patients will be asked to return to the study site for assessments on the Day 5, 1st month, 6th month and 12th month. Safety will be assessed by the investigator(s) at each return visit and will be monitored until the end of the study.

Eligibility

Age

50 - 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. Male or female with at least 50 years of age.
•4. 1 painful VCF which meet all of the following criteria:
•1. Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points).
•2. VCF between T7 and L4.
•3. Fracture age \< 3 months.
•4. 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.
•5. The Index fracture is acute or persistent (not healed), as demonstrated by MRI or bone scan.
•5. 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.
+2 more criteria

Exclusion Criteria

•1. Target VCF due to high-energy trauma or underlying/suspected tumor.
•2. Target VCF is diagnosed as an osteonecrosis.
•3. Segmental kyphosis of target vertebral compression \> 30°.
•4. Any prior surgical treatment for a VCF or other surgical procedure on the target vertebral body or adjacent level.
•5. The patient has uncontrolled systemic diabetes (A1c \> 10) and /or uncontrolled hypertension (patient requiring 3 or more anti-hypertensive drugs).
•6. Pre-existing or clinically unstable neurologic deficit.
•7. Spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
•8. Any physical exam evidence of myelopathy, radiculopathy, or coagulopathy.
•9. 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).
•10. Patient not able to walk without assistance prior to fracture.
+22 more criteria

Locations (1)

National Cheng Kung University Hospital Department of Orthopedics

Tainan, Taiwan

Key Dates

Start Date

June 16, 2023

Primary Completion Date

January 31, 2026

Completion Date

September 30, 2026

Last Updated

July 9, 2025

Enrollment

ESTIMATED participants

Conditions

Osteoporotic Vertebral Compression Fractures

Interventions

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

DEVICE

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

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Osteoporotic Vertebral Compression Fractures

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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: July 9, 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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

Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients

Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures