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CompletedNCT06270173Updated Nov 6, 2026

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

An interventional study of Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) in Osteoporotic Vertebral Compression Fractures, sponsored by Wiltrom Co., Ltd.. Completed at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Wiltrom Co., Ltd. · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Osteoporotic Vertebral Compression Fractures

Browse trials for

03

In context

Fractures, Compression

50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.

This study's enrollment of 53 is below the median of 73 across 32 interventional studies indexed under Fractures, Compression.

Browse Fractures, Compression studies →

Lead sponsor

This is the only study on the registry with Wiltrom Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of signed and dated form prior to any study procedures
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Skeletally mature males and females

  4. 1 painful VCF which meets all of the following criteria:

    1. Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points)
    2. VCF between T6 and L5
    3. 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.
    4. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is for MRI).
  5. Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.

Exclusion criteria

Exclusion Criteria:

Tripod-Fix is not indicated for any other application other than that for which it is designed. for Tripod-Fix include, but are not limited to: .

  1. Patient presenting a loss of vertebral height >50% compared to estimated pre-fracture height
  2. Sclerotic fracture
  3. Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
  4. Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
  5. Active infection (systemic or in the target vertebra)
  6. Patient suffering from a severe or uncontrolled systemic disease
  7. Patient presenting a pathological fracture with the presence of a mass within the spinal canal
  8. Patient presenting neurological damage caused by vertebral fracture
  9. Patient pregnant or likely to be so or breastfeeding
  10. Patient vertebral anatomy not compatible with the size of the implant or instrumentation
  11. Fracture geometry making the insertion of the implant impossible
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Intervention

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

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

Interventions

  • DeviceTripod-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.

06

What researchers measure

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.

    Time frame: 12 months post-procedure

07

Study locations

4 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Feb 2024 to primary completion in Jun 2026, 28 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Dec 2025 → Jun 2026 and completion Feb 2026 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2024
First posted
Feb 21, 2024
StartActual
Feb 16, 2024
Primary completionActual
Jun 30, 2026was Dec 2025
CompletionActual
Sep 28, 2026was Feb 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 6, 2026
Sites
3 sites added, 3 sites removed
Show 3 added (3 Germany)
  • Klinikum Friedrichshafen · Friedrichshafen, Germany
  • University Hospital Mannheim · Mannheim, Germany
  • Krankenaus Mechernich · Mechernich, Germany
Show 3 removed
  • Klinikum Friedrichshafen · Friedrichshafen, Germany
  • University Hospital Mannheim · Mannheim, Germany
  • Krankenaus Mechernich · Mechernich, Germany
Nov 6, 2026
Primary completion
Dec 31, 2025→Jun 30, 2026 (actual)
Nov 6, 2026
Study completion
Feb 28, 2026→Sep 28, 2026 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Active, not recruiting→Completed
    3 sites added, 3 sites removed
    Show 3 added (3 Germany)
    • Klinikum Friedrichshafen · Friedrichshafen, Germany
    • University Hospital Mannheim · Mannheim, Germany
    • Krankenaus Mechernich · Mechernich, Germany
    Show 3 removed
    • Klinikum Friedrichshafen · Friedrichshafen, Germany
    • University Hospital Mannheim · Mannheim, Germany
    • Krankenaus Mechernich · Mechernich, Germany
    Primary completion Dec 31, 2025→Jun 30, 2026 (now actual)
    Study completion Feb 28, 2026→Sep 28, 2026 (now actual)
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06270173
Lead sponsor
Wiltrom Co., Ltd.
Collaborators
Avania
Responsible party
Sponsor
First posted
Feb 21, 2024
Start date
Feb 16, 2024
Primary completion
Jun 30, 2026
Completion
Sep 28, 2026
Last update
Nov 6, 2026

Study contacts

Te-Yang Tsai
study director · Wiltrom Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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