Distal radius fractures
Conditions
Interventions
Closed reduction and intramedullary fixation using the IlluminOss® Photodynamic Bone Stabilization 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 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) 3. Capable of independent activities of daily living prior to index injury 4. Closed reduction and intramedullary fixation using the IlluminOss® PBSS within 14 days after trauma 5. Provision of informed consent by patient
Exclusion criteria
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 3. Patients with an impaired wrist function at the affected side due to arthrosis, rheumatoid disorder, or neurological disorder prior to the injury 4. Patients with a bone disorder which may impair bone healing, excluding osteoporosis (e.g., Paget’s disease, renal osteodystrophy, osteomalacia) 5. Patients unwilling or unable to comply with the after-care protocol and follow-up visit schedule 6. Insufficient comprehension of the Dutch language to understand the rehabilitation program and other treatment information in the judgment of the attending physician 7. Participation in another surgical intervention or drug study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disabilities of the Arm, Shoulder, and Hand (DASH) score | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
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