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Evaluation of Functional Recovery after Treatment of Fractures using the IlluminOss® System (IO-ALL study); A Multicenter Prospective Observational Study


- candidate number23572
- NTR NumberNTR5635
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2016
- Secondary IDsMEC-2015-732 (METC Erasmus MC) 
- Public TitleEvaluation of Functional Recovery after Treatment of Fractures using the IlluminOss® System (IO-ALL study); A Multicenter Prospective Observational Study
- Scientific TitleEvaluation of Functional Recovery after Treatment of Fractures using the IlluminOss® System (IO-ALL study); A Multicenter Prospective Observational Study
- ACRONYMIO-ALL
- hypothesisWe expect that treating patients with the IlluminOss® System will result in excellent recovery
- Healt Condition(s) or Problem(s) studiedFracture
- Inclusion criteria1. 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*
3. Provision of informed consent by patient.
- Exclusion criteria1. 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
3. Participation in another surgical intervention or drug trial.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate31-dec-2018
- Target number of participants150
- InterventionsClosed reduction and intramedullary fixation using the IlluminOss® System
- Primary outcomeNumber of patients treated per indication
- Secondary outcomeHospital 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))
- 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 Medical Center, Erasmus MC, Trauma Research Unit department of Surgery, Erasmus Medical Center, Medical Ethical Committee (METC)
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsNone yet; study is ongoing
- Brief summaryBACKGROUND In 2009, the IlluminOss® System (IlluminOss® Medical, East Providence, RI, USA) received CE mark clearance for minimally invasive use in the treatment of fractures of light to low load bearing bones. Its presumed benefits are 1) shorter operative time (as the percutaneous insertion requires less time than open invasive surgery); and 2) shorter length of hospital stay due to earlier (weight bearing) mobilization and resulting ADL independence. There is currently no overview for which indications the IlluminOss® System is being used nor of the treatment results.

AIM The main aim of this study is to determine how often and for which indications patients are treated with the IlluminOss® System. Secondary aims are to determine for subgroups with the same fracture type; 1) the hospital length of stay; 2) the time until discharge from follow-up; 3) the rate of complications (with associated treatment); 4) the Range of Motion (ROM) of the affected and contralateral side (only for extremity fractures); 5) the time to regaining independence in activities of daily living (ADL); and 6) the patient-reported quality of life, disability, functional outcome and pain.

STUDY DESIGN Multicenter Prospective Observational Study (case series)

POPULATION Study population: Adult patients (18 years or older) with a fracture that was treated with the IlluminOss® System.

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

ENDPOINTS Primary outcome measure: Number of patients treated per indication.
Secondary outcome measures: 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)).
PROM’s will completed at 2 and 6 weeks, and at 3, 6, and 12 months after surgery.

RECRUITING COUNTRIES The Netherlands
- Main changes (audit trail)
- RECORD6-jan-2016 - 28-feb-2016


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