Functional Recovery after Treatment of Extra-Articular Distal Radial Fractures in the Elderly using the IlluminOss® Photodynamic Bone Stabilization System (IO-Wrist); A Multicenter Prospective Observational Study
Completed
- Conditions
- Distal radius fractures
- Registration Number
- NL-OMON28700
- Lead Sponsor
- Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of SurgeryErasmus Medical Center, Medical Research Ethics Committee (MREC)
- Brief Summary
Hagenaars T, Van Oijen GW, Roerdink WH, Vegt PA, Vroemen JP, Verhofstad MHJ, Van Lieshout EMM. Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss® System (IO-Wrist); a multicenter prospective observational study. BMC Musculoskelet Disord. 2016 May 27;17:235.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Adult men or women with an age of 60 years or older (no upper age limit)
2. Patients with a unilateral extra-articular displaced distal radius fracture (AO type 23-A2 or 23-A3)
Exclusion Criteria
1. Additional traumatic injuries if this affects treatment, rehabilitation, or function of the affected hand
2. Patients with a pathological, recurrent, or open (i.e., Gustilo grade II or III) fracture
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disabilities of the Arm, Shoulder, and Hand (DASH) score
- Secondary Outcome Measures
Name Time Method Patient-Rated Wrist Evaluation (PRWE); Pain (VAS and analgesic use); Short Form-36 (SF-36); EuroQoL-5D (EQ-5D); Time to regaining ADL independence; Time to return to daily activities and work; Range of motion of the wrist; Radiographic evaluation; Complications and secondary interventions; Health care consumption with associated costs; Productivity loss with associated costs