Critical Bone Defects, Delayed Bone Healing, Nonunion Fracture
Conditions
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.
Interventions
OTHERIntraoperative 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.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device-related adverse events (% of participants) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon-reported usability score (Likert scale) | Immediately after the procedure | Assessment of device applicability and handling using a standardized surgeon questionnaire with a Likert scale rating immediately after use. |
| Rate of successful intraoperative bioactivation procedures | Intraoperatively (during the index surgical procedure) | 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). |
Countries
Germany
Outcome results
None listed