New device could supercharge bone healing using Patient's own tissue
NCT ID NCT07562165
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a device called the Boneflo Tissue Collector, which collects a patient's own tissue and blood during surgery to coat bone substitutes. The goal was to see if it is safe and easy to use for treating severe bone defects, non-unions, or delayed healing. 50 patients were treated across four centers, and the device was evaluated by surgeons and other medical staff. The study focused on safety and usability, with some early data on bone healing over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Boneflo® Tissue Collector System (device that collects patient's own tissue and blood to coat bone substitutes)
- What this could lead to
- If successful, this device could improve bone healing for people with severe fractures or bone defects, reducing the need for additional surgeries.
- What could go wrong
- This was a small pilot study with only 50 patients, focused on safety and usability, not on proving the device works better than standard care. The results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients with critical size bone defects, non-unions or delayed bone healing Indication for bone grafting (autologous, allogeneic, or synthetic) Age ≥ 18 years Written informed consent obtained prior to surgery Ability to comply with follow-up visits for at least 6 months Exclusion Criteria: Active local or systemic infection Vertebral body defects (according to device instructions for use) Active malignancy or tumor-related bone disease Severe systemic disease affecting bone healing (e.g., autoimmune disease, immunodeficiency) Contraindication to surgery or anesthesia Inability or unwillingness to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Marien-Hospital Mülheim an der Ruhr
Mülheim, 45468, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.