Complication,Postoperative, Surgery, Tibial Fractures
Conditions
Keywords
Intramedullary nailing, Tibia shaft fractures, Rotational malalignment, C-Arm Rotational View, multi-center randomized controlled trial.
Brief summary
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?
Interventions
DIAGNOSTIC_TESTC-Arm Rotational View (CARV)
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
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Multi-center randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotational (mal)alignment | Up to 12 months after initial surgery | 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. |
Countries
Australia, Netherlands
Contacts
Primary ContactNils Jan Bleeker, MD
Outcome results
None listed