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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03945669
Recruitment Status Recruiting
First Posted May 10, 2019
Last update posted May 7, 2021
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures. The primary aim of the project is to compare the one-year Knee Injury and Osteoarthritis Outcome Score - Sport (KOOS-Sport) after standard intramedullary nailing with external ring fixation for patients with tibial shaft fractures. The explorative aim is to report the effect of the two surgical procedures on the development of complications, time to bone union, pain reactions, muscle strength, activity of daily living and time to return to work.
|Active Comparator: Intramedullary Nail
Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.
Procedure: Intramedullary Nailing
fracture fixation of the tibial shaft fracture with an intramedullary nail.
|Experimental: External Ring fixator
External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry.
Procedure: External Ring fixation
fracture fixation of the tibial shaft fracture with an external ring fixator.
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- Fracture of the tibial shaft
- OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3
- The fracture type is deemed operable by intramedullary nail
- Below 18 years of age
- Open fracture
- History of severe systemic diseases or cancer
- Bilateral tibial shaft fracture
- Multi fracture patients
- Patients without gait function prior to fracture
Contact: Rasmus Elsøe, PhD +4597660000 email@example.com
Contact: Peter Larsen, PhD +4597660000 firstname.lastname@example.org
Aalborg University Hospital, Department of orthopaedic surgery
Aarhus University Hospital
Regional Hospital Viborg
Aalborg University Hospital
Danish Council for Independent Research
Study Director: Rasmus Elsøe, PhD Aalborg University Hospital
Principal Investigator: Rasmus Stokholm, MD Aalborg University Hospital
Principal Investigator: Peter Larsen, PhD Aalborg University Hospital