Osteoporotic Vertebral Compression FracturesNCT06270173
Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures
A study testing Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) in people with Osteoporotic Vertebral Compression Fractures, run by Wiltrom Co., Ltd. at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporotic Vertebral Compression Fractures
- 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
- 53 participants
- Where
- 4 sitesGermany
- Study dates
- 16 Feb 2024to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 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
- Skeletally mature males and females
- 1 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
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- 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.
Who cannot join
- 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
- Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
- Active infection (systemic or in the target vertebra)
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- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Johann Wolfgang Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, 60596
Klinikum Friedrichshafen
Friedrichshafen, Baden-Wurttemberg, 88048
University Hospital Mannheim
Mannheim, Baden-Wurttemberg, 68167
Krankenaus Mechernich
Mechernich, North Rhine-Westphalia, 53894
About this study
Official title: 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
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.
Read the 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.
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Tripod-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.
Proportion of participants with study success
Study success is defined as follows:
- 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
- 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,
- Absence of device-related serious adverse events.
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.
- First posted21 Feb 2024
- Study start16 Feb 2024
- Primary completion30 Jun 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Vertebral Compression FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wiltrom Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Te-Yang Tsai, Study director, Wiltrom Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270173
- Sponsor's protocol ID
- TWM-C-2202
- Status last verified
- Nov 2026
- First submitted
- 13 Feb 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06270173
- Acronym / sponsor ID
- TWM-C-2202
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Wiltrom Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)Tripod-Fix will be used to treat osteoporotic vertebral compression fractures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 1 painful VCF which meets all of the following criteria:
- Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.
Key exclusion criteria (12 listed)
- 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
- Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)The Tripod-Fix is a permanent implant used for vertebral augmentation in patients with osteoporotic vertebral compression fractures. | Device | Intervention |
Primary outcome
Proportion of participants with study success
Time frame: 12 months post-procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Te-Yang Tsai study director
Wiltrom Co., Ltd.
4 sites in 1 country: see every site and its status.
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 Wiltrom Co., Ltd. at 4 sites in Germany.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 6 Nov 2026.