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

BACKGROUND
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

We expect that treating patients with the IlluminOss® System will result in excellent recovery

Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months

Closed reduction and intramedullary fixation using the IlluminOss® System