Large size bone defects of long bones of the upper and lower extremity
Conditions
Interventions
Group 1: This study is a prospective, single-center, clinical observational study investigating neoangiogenesis in combination with the use of a 3D-printed, patient individually polycaprolactone (PCL)
Sponsors
Klinik für Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients suffering from non-union of long bones of the upper and lower extremity with a defect size of 1-125 cm3, who are to undergo surgical treatment with autologous bone grafting. 2. Written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Acute or suspected local infections (including osteomyelitis) at or near the defect site. 2. Acute or suspected active systemic infections. 3. Allergies to components of the osteosynthesis material or to polycaprolactone. 4. Extensive soft tissue defects at or near the surgical site. 5. Pre-existing conditions or drug therapies that affect bone healing and wound healing (chemotherapy, radiation, bisphosphonates, etc.). 6. Cancer or bone metastases that are the cause of the bone defect. 7. Drug-induced immunosuppression. 8. Haemostatic disorders or immune diseases that affect healing. 9. Therapeutic anticoagulation (DOAK, Marcumar). 10. Untreated hypertension/diabetes mellitus requiring treatment. 11. Planned surgery elsewhere in the next 3 years. 12. Active smoker and/or drug abuse. 13. Pregnancy, planned (up to 3 years) / suspected pregnancy or breastfeeding. 14. Central neurological deficits that do not ensure sufficient compliance, especially for follow-up treatment in the study. 15. Existing contraindications for the use of the implant (as listed in the manufacturer's brochure). 16. Existing contraindications for performing standard follow-up examinations (CEUS, DCE-MRI): - Contrast agent intolerance (CEUS, MRI) - Known right-to-left shunt - Severe pulmonary hypertension - Implants not suitable for MRI/non-removable foreign bodies 17. Inability to participate in our standardized follow-up program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of blood perfusion using contrast-enhanced ultrasound (CEUS) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) 3 months after therapy, as well as creation of an angiogenesis marker profile over the first 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Bony consolidation and resorption of the implant: within 12 months or 24 months in conventional X-ray and CT imaging • Lower Extremity Functional Scale (LEFS) or Disability Arm Shoulder Hand (DASH) assessment to evaluate the extremities' function. • Time to return to work. • Health-related quality of life: SF-12 • Pain: Visual analog scale (VAS) score • Health questionnaire: EQ-5D-5L • Length of inpatient stay. • Surgical costs and costs of inpatient stay • Adverse effects of the implant during surgery or in the further postoperative course. | — |
Countries
Germany
Contacts
Public ContactTim Bewersdorf
Klinik für Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Heidelberg
Outcome results
None listed