Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.

Study Overview
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Brief Summary
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Tibia shaft fractures are common long bone fractures in the field of Orthopaedic Trauma. In the USA, a total of 492.000 tibial fractures were reported per year by the National Center of Health Statistics (NCHS). Intramedullary nailing (IMN) is the treatment of choice for shaft fractures. However, rotational malalignment (RM) remains an iatrogenic pitfall with a prevalence up to 30%. From a clinical point of view, there is limited knowledge on how to avoid RM during IMN. Clinical estimation of tibial alignment is difficult, resulting frequently in RM following IMN. Low-dose CT-assessment is considered the gold standard to objectify RM, but is performed after surgery when the opportunity for direct revision has passed. Both difficulties in intraoperative clinical judgement of tibial alignment as well as postoperative detection of RM when the possibility for direct revision has passed, do support the need for an easy-to-use intraoperative fluoroscopy protocol to minimize the risk for RM during IMN of tibial shaft fractures. Recently, a standardized intraoperative fluoroscopy protocol named the 'C-Arm Rotational View (CARV)' was determined in order to improve the accuracy of alignment control during IMN of tibial shaft fractures. CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used. Promising preliminary results were found to reduce the risk on RM following IMN of tibia fractures. However, a prospective trial is needed to determine the performance of CARV in clinical practice. Therefore, a prospective multi-center randomized controlled trial is designed to assess the clinical feasibility and potential benefits of the CARV-protocol. The following primary research question was defined: can the risk for RM following IMN of tibial shaft fractures be minimized by use of the CARV-protocol?

Official Title
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Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures.

Conditions
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Tibial Fractures, Surgery, Complication,Postoperative

Intervention / Treatment
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* Diagnostic Test: C-Arm Rotational View (CARV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive patients (≥18 years) with an open or closed tibia shaft fracture, who are eligible for IMN, will be asked to enroll in the study Exclusion Criteria: The following exclusion criteria will be used: age <18 years, fractures not suitable for IMN and pathological fractures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Patients assigned to the interventional group will undergo an identical surgical procedure as patients assigned to the control group. The only difference with the control group is that tibial alignment will be obtained according to the standardized CARV-protocol. | Diagnostic Test: C-Arm Rotational View (CARV)<br>* CARV includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the C-Arm Image Intensifier is used<br>|
| No Intervention: Control group<br>Patients assigned to the control group will undergo an identical surgical procedure as patients assigned to the interventional group. The only difference with the intervention group is that tibial alignment will be obtained according to present unstandardized clinical standards | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational (mal)alignment | Determine the incidence of RM using postoperative CT-assessment. In literature, RM is defined as a rotation ≥10 degrees relative to the contralateral side. However, considering the physiological left-right difference of 4 degrees between left and right-sided tibiae, with right-sided tibiae on average 4 degrees more externally rotated, RM is defined as malrotation of < -6 degrees or >14 degrees in right-sided tibiae and < -14 degrees or >6 degrees in left-sided tibiae. A negative angle represents internal rotation and positive angle external rotation. | Up to 12 months after initial surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intramedullary nailing, Tibia shaft fractures, Rotational malalignment, C-Arm Rotational View, multi-center randomized controlled trial.