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

University Medical Center Groningen (UMCG)

Status: Not yet enrolling

Conditions: Tibial Fractures; Surgery; Complication,Postoperative

Treatments: Diagnostic Test: C-Arm Rotational View (CARV)

Study type: Interventional

Funder types: Other

Identifiers

NCT05459038

81191

Details and patient eligibility

About

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?

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Interventional group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: C-Arm Rotational View (CARV)

Control group

No Intervention group

Description:

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