Surgical use of 3D printed cages as adittion for the filling of large bone defects, a randomised controlled trial

Conditions: Critical size bone defect
fracture
10005944

Registration Number: NL-OMON56816

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 26

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

Segmental bone defects < 5 cm in length after debridement
Inability to understand the Dutch language
Inability to comply with follow-up
Untreated metabolic comoribities (such as diabetes and osteoporosis)
Patients with cancer or bone defects due to a malignancy
Unable to participate judged by treating physician
Paraplegia
Interoperative exclusion due to instrumental problems

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Follow-up is scheduled at regular intervals; six weeks, twelve weeks, six<br /><br>months, and one year. The primary study endpoint is the volume of newly formed<br /><br>bone at the defect site, based on CT-scans at six months follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are secondary interventions, quality of life<br /><br>(EQ-5D5L, PROMIS), lower extremity function scale or disabilities of the arm,<br /><br>shoulder and hand (DASH) questionnaire if applicable, necessary<br /><br>reinterventions, recurrence/persistence of infection, burden-of-disease and<br /><br>cost-effectiveness, including the Medical Consumption Questionnaires (MCQ) and<br /><br>Productivity Cost Questionnaire (PCQ). </p><br>