Evaluation of Functional Recovery after Treatment of Fractures using the IlluminOss® System (IO-ALL study); A Multicenter Prospective Observational Study
Completed
- Conditions
- Fractures treated with the IlluminOss® System
- Registration Number
- NL-OMON27661
- Lead Sponsor
- Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of SurgeryErasmus Medical Center, Medical Research Ethics Committee (MREC)
- Brief Summary
one yet; study is ongoing
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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*
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients treated per indication
- Secondary Outcome Measures
Name Time Method 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))