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Osteoporotic Vertebral Compression FracturesNCT06261242

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

A study testing Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) in people with Osteoporotic Vertebral Compression Fractures, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteTaiwan
Study dates
16 Jun 2023to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 1 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Active systemic or local infection at baseline.
  • Body mass index > 40.
  • Patients affected by severe cardiopulmonary deficiencies.
  • 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: Likely to impair long-term follow-up (e.g., cancer).
  • Any evidence of alcohol or drug abuse.
  • Uncontrolled psychiatric disorders are defined by the DSM V or severe dementia.
  • Currently on anti-cancer therapy or anti-HIV therapy.
  • Life expectancy is less than the study duration or undergoing palliative care.
  • Participating in any other investigational study.
  • On long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months).
  • Known to be involved in spinal litigation.
  • Pregnant women as confirmed by positive pregnancy test or considering getting pregnant during study participation.
  • Presenting loss of vertebral height > 50% compared to estimated pre-fracture height.
  • Interspinous-process widening.
  • Sclerotic fracture or pseudarthrosis.
  • Patient is a prisoner or not in the wards of the court.
  • Patients with contraindications to MRI and bone scan.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University Hospital Department of Orthopedics

    Tainan, 704

Other trials in Taiwan

About this study

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

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06261242
Study groupRoleWhat they receive
InterventionExperimentalTripod-Fix will be used to treat osteoporotic vertebral compression fractures.
Receives: Device: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start16 Jun 2023
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06261242
Sponsor's protocol ID
TWM-C-2201
Status last verified
Feb 2025
First submitted
7 Feb 2024
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) in people with Osteoporotic Vertebral Compression Fractures, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with study success (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06261242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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