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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


- candidate number22912
- NTR NumberNTR5457
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2015
- Secondary IDsMEC-2015-283 (METC Erasmus MC) 
- Public TitleFunctional 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
- Scientific TitleFunctional 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
- ACRONYMIO-Wrist
- hypothesisWe expect that treating patients with the IlluminOss PBSS will result in excellent functional recovery of function (i.e., low DASH and high PRWE and ADL scores) within three months after trauma.
- Healt Condition(s) or Problem(s) studiedDistal radius fracture
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate31-dec-2017
- Target number of participants50
- InterventionsClosed reduction and intramedullary fixation using the IlluminOss® Photodynamic Bone Stabilization System
- Primary outcomeDisabilities of the Arm, Shoulder, and Hand (DASH) score
- Secondary outcomePatient-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
- TimepointsBaseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
- Trial web siteNone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD PhD M.H.J. Verhofstad
- CONTACT for SCIENTIFIC QUERIESMD PhD M.H.J. Verhofstad
- Sponsor/Initiator Erasmus MC, Trauma Research Unit department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
IlluminOss Medical Inc, East Providence, RI, USA
- PublicationsNone yet; study is ongoing
- Brief summaryBACKGROUND
Up to 30% of patients with a distal radius fracture suffer from long-term functional restrictions after non-operative treatment. The IlluminOss® Photodynamic Bone Stabilization System (PBSS) is a novel implant. It comprises intramedullary fracture fixation using a percutaneous approach. The percutaneous nature of the operative procedure is aimed at reducing the risks associated with traditional open reduction and internal fixation. Operative fixation with the IlluminOss® PBSS allows for early mobilization and may theoretically lead to earlier functional recovery and earlier ADL independence than plaster immobilization.

AIM
The primary aim of this prospective, multicenter, observational study is to examine the DASH (Disabilities of the Arm, Shoulder, and Hand) score in elderly patients who sustained a unilateral displaced distal radius fracture (DRF) that was treated with the IlluminOss® Photodynamic Bone Stabilization System. Secondary aims are to assess the effect on treatment on functional outcome, pain, health-related quality of life, time to regaining ADL independence, time to resumption of daily activities and work, ROM, complications, and costs for health care use and lost productivity in these patients.

STUDY DESIGN
Multi-center observational study. Approximately 4-6 hospitals in the Netherlands will participate.

POPULATION
Elderly patients (60 years or older; independent in activities of daily living) with a unilateral displaced distal radius fracture (AO type 23-A2 and 23-A3) that was successfully closed reduced within 12 hours of presentation to the Emergency Department and treated with the IlluminOss® Photodynamic Bone Stabilization System within 14 days are eligible.

INTERVENTION
Closed reduction and percutaneous intramedullary fixation using the IlluminOss® Photodynamic Bone Stabilization System

ENDPOINTS
Primary outcome measure: DASH score. Secondary outcome measures: functional outcome (PRWE); pain (VAS); health-related quality of life (SF-36 and EuroQoL-5D); ADL independence; work/ADL resumption; ROM; radiological outcome; complications; costs for health care use and lost productivity.
Primary and secondary outcomes will be determined at 2 and 6 weeks, and at 3, 6, and 12 months after surgery.

RECRUITING COUNTRIES
The Netherlands.
- Main changes (audit trail)
- RECORD29-sep-2015 - 6-dec-2015


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