Fractures treated with the IlluminOss® System
Conditions
Interventions
Closed reduction and intramedullary fixation using the IlluminOss® System
Sponsors
Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of Surgery
Erasmus Medical Center, Medical Research Ethics Committee (MREC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult men or women with an age of 18 years or older (no upper age limit) 2. Patients with a fracture treated using the IlluminOss® System* 3. Provision of informed consent by patient.
Exclusion criteria
Exclusion criteria: 1. Patients unwilling or unable to comply with the after-care protocol and follow-up visit schedule 2. Insufficient comprehension of the Dutch language to understand the rehabilitation program and other treatment information in the judgment of the attending physician 3. Participation in another surgical intervention or drug trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients treated per indication | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital length of stay; Time until discharge from clinical follow-up; Complications with associated treatment; Range of Motion (for extremity fractures only); Time to regaining independence in activities of daily living (ADL); Patient-reported quality of life, disability, functional outcome, and pain (as applicable: Short Form-36 (SF-36), Short Musculoskeletal Functional Assessment (SMFA),Disabilities of the Arm, Shoulder, and Hand (DASH), Patient-Rated Wrist Evaluation (PRWE), and Lower Extremity Functional Scale (LEFS)) | — |
Contacts
Public ContactM.H.J. Verhofstad
Erasmus MC, Trauma Research Unit, dept. of Surgery - Mailbox H-822k 's-Gravendijkwal 230, 3015 CE Rotterdam
Outcome results
None listed