Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures (IMVEX)

Aalborg University Hospital

Status: Completed

Conditions: Tibial Shaft Fracture

Treatments: Procedure: External Ring fixation; Procedure: Intramedullary Nailing

Study type: Interventional

Funder types: Other

Identifiers

NCT03945669

LERG1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Below 18 years of age
• Open fracture
• History of severe systemic diseases or cancer
• Bilateral tibial shaft fracture
• Multi fracture patients
• Pregnancy
• Patients without gait function prior to fracture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Intramedullary Nail

Active Comparator group

Description:

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.

Treatment:

Procedure: Intramedullary Nailing

External Ring fixator

Experimental group

Description:

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.

Treatment:

Procedure: External Ring fixation