Nonunion FractureBoneFloNCT07562165
Using the Boneflo System During Orthopedic and Trauma Surgery: A Prospective Multicenter Study
A study testing Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System. in people with Nonunion Fracture and Delayed Bone Healing, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
Critical bone defects, non-unions, and delayed bone healing remain major challenges in orthopedic and trauma surgery and often require bone grafting. While a patient's own bone (autograft) is considered the gold standard, its use is limited by donor-site morbidity and limited availability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonunion Fracture, Delayed Bone Healing, Critical Bone Defects
- What is being tested?
- Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 1 Mar 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Intraoperative Use and Handling of the Boneflo Tissue Collector System in Orthopedic and Trauma Surgery
Critical bone defects, non-unions, and delayed bone healing remain major challenges in orthopedic and trauma surgery and often require bone grafting. While a patient's own bone (autograft) is considered the gold standard, its use is limited by donor-site morbidity and limited availability. Synthetic bone substitutes offer an alternative but mainly provide structural support and lack biological activity.
This prospective multicenter pilot study evaluates the safety and feasibility of using the Boneflo® Tissue Collector System to biologically activate bone substitutes during surgery. The device collects the patient's own tissue, blood, and biologically active factors directly from the surgical site using a vacuum-assisted suction system with an integrated filter. This material is then used intraoperatively to coat and bioactivate bone substitute materials.
Read more
In healing attempts, 50 patients with critical bone defects, non-unions, or impaired bone healing were treated across four centers. Various bone substitutes, including synthetic calcium phosphate materials, collagen-based scaffolds, and allografts, were used.
The primary aim of the study was to evaluate device safety, intraoperative usability, handling, and applicability for coating and activating bone substitutes. The device was evaluated by orthopedic surgeons and other medical professionals, including nurses, physician assistants, and technical assistants.
Furthermore, these data were supplemented with clinical outcome data from healing attempts, including wound healing and radiographic bone regeneration, assessed over a minimum six-month follow-up period.
- Being tested
- Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System.
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System.Other
During surgery, autologous tissue, blood, and biologically active components are collected from the surgical site under vacuum conditions with an integrated filter system using the BoneFlo tissue collector. The collected autologous material is used to coat and biologically enhance bone substitutes. Bone substitutes include calcium phosphate ceramics, collagen-based scaffolds, and allografts. This intervention is performed intraoperatively and aims to improve the biological activity of otherwise mainly osteoconductive materials.
| Study group | Role | What they receive |
|---|---|---|
| Bioactivated Bone Substitutes Using a Surgical Suction Device | Other | Synthetic bone substitutes were intraoperatively activated using autologous tissue in patients with critical bone defects, non-unions, and delayed bone healing. During surgery, autologous tissue, blood, and biologically active components were collected from the surgical site under vacuum conditions using an integrated filter system. The collected material was used to coat and biologically activate bone substitutes, including calcium phosphate ceramics, collagen-based scaffolds, and allografts. The primary focus was on safety, intraoperative usability, handling, and applicability of the device for bone substitute bioactivation. These data were combined with clinical outcomes in healing attempts, including wound healing and radiographic bone regeneration over a six-month follow-up period. Receives: Other: Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related adverse events (% of participants)
Assessment of safety of the surgical suction device used for intraoperative bioactivation of bone substitutes, measured by the number and proportion of participants experiencing device-related adverse events, as recorded in clinical evaluation and adverse event reporting.
Measured: Up to 30 days postoperatively
Secondary outcomes (2)
Surgeon-reported usability score (Likert scale)
Assessment of device applicability and handling using a standardized surgeon questionnaire with a Likert scale rating immediately after use.
Measured: Immediately after the procedure
Rate of successful intraoperative bioactivation procedures
Assessment of intraoperative feasibility based on successful completion of the procedure as judged by the operating surgeon. The unit of measure is the percentage of procedures (% of procedures).
Measured: Intraoperatively (during the index surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jul 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonunion FractureStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Sowislok, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562165
- Sponsor's protocol ID
- BO/35/2025-Studie-01
- Other IDs
- BO/35/2025-Studie-01
- Acronym
- BoneFlo
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Intraoperative Use and Handling of the Boneflo Tissue Collector System in Orthopedic and Trauma Surgery
- ClinicalTrials.gov ID
- NCT07562165
- Acronym / sponsor ID
- BoneFlo / BO/35/2025-Studie-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 1 May 2026 (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.
Critical bone defects, non-unions, and delayed bone healing remain major challenges in orthopedic and trauma surgery and often require bone grafting. While a patient's own bone (autograft) is considered the gold standard, its use is limited by donor-site morbidity and limited availability. Synthetic bone substitutes offer an alternative but mainly provide structural support and lack biological activity.
This prospective multicenter pilot study evaluates the safety and feasibility of using the Boneflo® Tissue Collector System to biologically activate bone substitutes during surgery. The device collects the patient's own tissue, blood, and biologically active factors directly from the surgical site using a vacuum-assisted suction system with an integrated filter. This material is then used intraoperatively to coat and bioactivate bone substitute materials.
In healing attempts, 50 patients with critical bone defects, non-unions, or impaired bone healing were treated across four centers. Various bone substitutes, including synthetic calcium phosphate materials, collagen-based scaffolds, and allografts, were used.
The primary aim of the study was to evaluate device safety, intraoperative usability, handling, and applicability for coating and activating bone substitutes. The device was evaluated by orthopedic surgeons and other medical professionals, including nurses, physician assistants, and technical assistants.
Furthermore, these data were supplemented with clinical outcome data from healing attempts, including wound healing and radiographic bone regeneration, assessed over a minimum six-month follow-up period.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioactivated Bone Substitutes Using a Surgical Suction Device | Other | Other: Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System.Synthetic bone substitutes were intraoperatively activated using autologous tissue in patients with critical bone defects, non-unions, and delayed bone healing. During surgery, autologous tissue, blood, and biologically active components were collected from the surgical site under vacuum conditions using an integrated filter system. The collected material was used to coat and biologically activate bone substitutes, including calcium phosphate ceramics, collagen-based scaffolds, and allografts. The primary focus was on safety, intraoperative usability, handling, and applicability of the device for bone substitute bioactivation. These data were combined with clinical outcomes in healing attempts, including wound healing and radiographic bone regeneration over a six-month follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System.During surgery, autologous tissue, blood, and biologically active components are collected from the surgical site under vacuum conditions with an integrated filter system using the BoneFlo tissue collector. The collected autologous material is used to coat and biologically enhance bone substitutes. Bone substitutes include calcium phosphate ceramics, collagen-based scaffolds, and allografts. This intervention is performed intraoperatively and aims to improve the biological activity of otherwise mainly osteoconductive materials. | Other | Bioactivated Bone Substitutes Using a Surgical Suction Device |
Primary outcome
Incidence of device-related adverse events (% of participants)
Time frame: Up to 30 days postoperatively
Assessment of safety of the surgical suction device used for intraoperative bioactivation of bone substitutes, measured by the number and proportion of participants experiencing device-related adverse events, as recorded in clinical evaluation and adverse event reporting.
2 secondary outcomes
Surgeon-reported usability score (Likert scale)
Time frame: Immediately after the procedure
Rate of successful intraoperative bioactivation procedures
Time frame: Intraoperatively (during the index surgical procedure)
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 1 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System. in people with Nonunion Fracture and Delayed Bone Healing, run by Universität Duisburg-Essen at 1 site 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 5 inclusion and 6 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 1 May 2026. 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 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?
Incidence of device-related adverse events (% of participants) (time frame: Up to 30 days postoperatively). 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 1 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.