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

NCT07562165 | Completed

• 1 other identifier: BO/35/2025-Studie-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Delayed Bone Healing; Critical Bone Defects; Nonunion Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Surgeon-reported usability score (Likert scale)

  Immediately after the procedure

• Rate of successful intraoperative bioactivation procedures

  Intraoperatively (during the index surgical procedure)

Study Arms (1)

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.

Other: Intraoperative bioactivation of bone substitute materials using the Boneflo® Tissue Collector System.

Interventions

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.

Bioactivated Bone Substitutes Using a Surgical Suction Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

St. Marien-Hospital Mülheim an der Ruhr

Mülheim, 45468, Germany

Location

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 1, 2026
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)