Using the Boneflo System During Orthopedic and Trauma Surgery: A Prospective Multicenter Study (BoneFlo)

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.

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 Overview

• Status: Completed
• Conditions: Nonunion Fracture; Delayed Bone Healing; Critical Bone Defects
• Intervention / Treatment: Other: Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mülheim, Germany, 45468
    • St. Marien-Hospital Mülheim an der Ruhr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Bioactivated Bone Substitutes Using a Surgical Suction Device; 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Intraoperatively (during the index surgical procedure)

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Ununited
• Other Study ID Numbers: BO/35/2025-Studie-01 (Other Identifier: Ärztekammer Niedersachsen (Ethics Committee))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No