|- candidate number||22912|
|- NTR Number||NTR5457|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-sep-2015|
|- Secondary IDs||MEC-2015-283 (METC Erasmus MC) |
|- Public Title||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|
|- Scientific Title||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|
|- hypothesis||We 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) studied||Distal radius fracture|
|- 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||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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jul-2015|
|- planned closingdate||31-dec-2017|
|- Target number of participants||50|
|- Interventions||Closed reduction and intramedullary fixation using the IlluminOss® Photodynamic Bone Stabilization System|
|- Primary outcome||Disabilities of the Arm, Shoulder, and Hand (DASH) score|
|- Secondary outcome||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|
|- Timepoints||Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months|
|- Trial web site||None|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD PhD M.H.J. Verhofstad|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD M.H.J. Verhofstad|
|- Sponsor/Initiator ||Erasmus MC, Trauma Research Unit department of Surgery|
(Source(s) of Monetary or Material Support)
|IlluminOss Medical Inc, East Providence, RI, USA|
|- Publications||None yet; study is ongoing|
|- Brief summary||BACKGROUND|
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.
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.
Multi-center observational study. Approximately 4-6 hospitals in the Netherlands will participate.
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.
Closed reduction and percutaneous intramedullary fixation using the IlluminOss® Photodynamic Bone Stabilization System
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.
|- Main changes (audit trail)|
|- RECORD||29-sep-2015 - 6-dec-2015|