Clinical trial NCT03945669: Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures
Official title: Intramedullary Nailing Versus External Ring Fixation for Surgical Treatment of Tibial Shaft Fractures in Adults and Their One Year Outcome on Recovery: Study Protocol for a Pragmatic Randomized Controlled Trial (The IMVEX Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Shaft Fracture
Keywords: External ring fixation
Intramedullary nailing
Tibial shaft fracture
patient reported outcome
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Council for Independent Research
First posted: 2019-05-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
timeFrame: 12 month follow up
Secondary outcomes:
measure: Perceived Pain
timeFrame: 6 weeks, 3+6+12 months
measure: Patient-reported pain reactions
timeFrame: 6 weeks, 3+6+12 months
measure: Pain sensitivity
timeFrame: 6 weeks, 3+6+12 months
measure: Muscle strength
timeFrame: 6+12 months
measure: Time to bone union
timeFrame: 6 weeks, 3+6+12 months
measure: Radiological alignment
timeFrame: 6 weeks, 3+6+12 months
measure: Health related QOL
timeFrame: 6 weeks, 3+6+12 months
measure: Time to return to work
timeFrame: 6 weeks, 3+6+12 months
measure: Health economic evaluation
timeFrame: 12 months
measure: Gait assessment
timeFrame: 3+6+12 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 3+6+12 months
measure: The Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 weeks, 3+6+12 months
measure: Foot And Ankle Outcome Score (FAOS)
timeFrame: 6 weeks, 3+6+12 months
Other outcomes:
measure: Adverse events
timeFrame: 6 weeks, 3+6+12 months
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Department of orthopaedic surgery
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Viborg
country: Denmark
facility: Regional Hospital Viborg
Study officials:
affiliation: Aalborg University Hospital
name: Rasmus Elsøe, PhD
role: STUDY_DIRECTOR
affiliation: Aalborg University Hospital
name: Rasmus Stokholm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Peter Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: