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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2024-06-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tibial Shaft Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the nature of the study participants, care providers and investigator can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intramedullary Nailing

Intervention Type PROCEDURE

fracture fixation of the tibial shaft fracture with an intramedullary nail.

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.

Group Type EXPERIMENTAL

External Ring fixation

Intervention Type PROCEDURE

fracture fixation of the tibial shaft fracture with an external ring fixator.

Interventions

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Intramedullary Nailing

fracture fixation of the tibial shaft fracture with an intramedullary nail.

Intervention Type PROCEDURE

External Ring fixation

fracture fixation of the tibial shaft fracture with an external ring fixator.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No