Critical size bone defect fracture
Conditions
Interventions
The control group will receive the standard treatment for these defects in our
center. This treatment consists of a two-stage surgical procedure called the
Induced Membrane Technique (IMT). During t
a physiological response to the implanted foreign body (the
cement spacer). If deemed necessary, soft tissue coverage via free flap
transfer is performed as well. In the second stage, the spacer is
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Posttraumatic critical size bone defect of 5 or more centimeters of a long bone after debridement Age over 18 years Informed consent for surgical treatment and participation in the study
Exclusion criteria
Exclusion criteria: Segmental bone defects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Follow-up is scheduled at regular intervals; six weeks, twelve weeks, six months, and one year. The primary study endpoint is the volume of newly formed bone at the defect site, based on CT-scans at six months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are secondary interventions, quality of life (EQ-5D5L, PROMIS), lower extremity function scale or disabilities of the arm, shoulder and hand (DASH) questionnaire if applicable, necessary reinterventions, recurrence/persistence of infection, burden-of-disease and cost-effectiveness, including the Medical Consumption Questionnaires (MCQ) and Productivity Cost Questionnaire (PCQ). | — |
Countries
Netherlands
Outcome results
None listed