Clinical validation of the 'C-arm rotational view (CARV)': study protocol of a prospective randomised controlled trial.

INTRODUCTION: Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined 'C-arm rotational view (CARV)' in order to reduce the risk of rotational malalignment during intramedullary nailing of tibial shaft fractures. The CARV includes predefined fluoroscopy landmark views of the uninjured side to obtain correct alignment of the injured side with use of the rotation of the C-arm. METHODS AND ANALYSIS: This randomised controlled trial will be conducted in a level 1 trauma centre. Adult patients with an open or closed tibial fracture, eligible for intramedullary nailing, will be enrolled in the study. The interventional group will undergo intramedullary nailing guided by the CARV protocol to obtain accurate alignment. The control group is treated according to current clinical practice, in which alignment control of the tibia is based on clinical estimation of the treating surgeon. The primary endpoint is defined as the degree of rotation measured on low-dose postoperative CT scans. ETHICS AND DISSEMINATION: The study protocol will be performed in line with local ethical guidelines and the Declaration of Helsinki. The results of this trial will be disseminated in a peer-reviewed manuscript. Future patients are likely to benefit from this trial as it aims to provide a clinically feasible and easy-to-use standardised fluoroscopy protocol to reduce the risk for rotational malalignment during intramedullary nailing of tibial shaft fractures. TRIAL REGISTRATION NUMBER: NCT05459038.

Intraoperative fluoroscopic protocol to avoid rotational malalignment after nailing of tibia shaft fractures: introduction of the 'C-Arm Rotational View (CARV)'.

PURPOSE: Rotational malalignment (≥ 10°) is a frequent pitfall of intramedullary-nailing of tibial shaft fractures. This study aimed to develop an intraoperative fluoroscopy protocol, coined 'C-Arm Rotational View (CARV)', to significantly reduce the risk for rotational malalignment and to test its clinical feasibility. METHODS: A cadaver and clinical feasibility study was conducted to develop the CARV-technique, that included a standardized intraoperative fluoroscopy sequence of predefined landmarks on the uninjured and injured leg in which the rotation of the C-arm was used to verify for rotational alignment. A mid-shaft tibia fracture was simulated in a cadaver and an unlocked intramedullary-nail was inserted. Random degrees of rotational malalignment were applied using a hand-held goniometer via reference wires at the fracture site. Ten surgeons, blinded for the applied rotation, performed rotational corrections according to (1) current clinical practice after single-leg and dual-leg draping, and (2) according to the CARV-protocol. The primary outcome measure was the accuracy of the corrections relative to neutral tibial alignment. The CARV-protocol was tested in a small clinical cohort. RESULTS: In total, 180 rotational corrections were performed by 10 surgeons. Correction according to clinical practice using single-leg and dual-leg draping resulted in a median difference of, respectively, 10.0° (IQR 5.0°) and 10.0° (IQR 5.0°) relative to neutral alignment. Single-leg and dual-leg draping resulted in malalignment (≥10°) in, respectively, 67% and 58% of the corrections. Standardized correction using the CARV resulted in a median difference of 5.0° (IQR 5.0°) relative to neutral alignment, with only 12% categorized as malalignment (≥10°). The incidence of rotational malalignment after application of the CARV decreased from 67% and 58% to 12% (p = <0.001). Both consultants and residents successfully applied the CARV-protocol. Finally, three clinical patients with a tibial shaft fracture were treated according to the CARV-protocol, resulting all in acceptable alignment (<10°) based on postoperative CT-measurements. CONCLUSION: This study introduces an easy-to-use and clinically feasible standardized intraoperative fluoroscopy protocol coined 'C-arm rotational view (CARV)' to minimize the risk for rotational malalignment following intramedullary-nailing of tibial shaft fractures.

The value of fibular fixation in patients with stabilized distal tibia fractures.

PURPOSE: There is currently no consensus regarding the need for fixation of concomitant fibula fractures in patients with surgically treated distal tibia fracture. Although studies have shown it to be beneficial for fractures involving the syndesmosis, it remains unclear for suprasyndesmotic fractures. This study evaluates what effect the fixation of such suprasyndesmotic fibula fractures had on patients who underwent fixation of distal tibia fractures. METHODS: This retrospective cohort study included all consecutive adult patients who received surgical treatment for an extra-articular or simple intraarticular distal tibia fracture between 2012 and 2020 and had a concomitant fibula fracture proximal to the syndesmosis. Two groups were formed depending on whether the fibula was stabilized. The need for revision surgery, the occurrence of complications, fracture healing, rotational and angular malalignment were evaluated for both groups. RESULTS: This study included 120 patients, of which 40 (33.3%) had operative treatment of the fibula fracture. Of those with stabilized fibula fractures, 28 (70%) were treated with a plate and 12 (30%) with a titanium elastic nail. The group of patients with surgically treated fibula fractures had significantly more angular malalignments (10% vs 1.2%, p = 0.042), while there was no difference regarding rotational malalignment or fracture healing. Further, infections of the fibular surgical site occurred in 15% of surgically treated patients leading to significantly more revision surgeries in this group (40% vs 20%, p = 0.03). All infections occurred when a plate was used. CONCLUSION: This study was unable to show any benefit from stabilizing concomitant, suprasyndesmotic fibula fractures in surgically treated distal tibia fractures. On the contrary, infection, revision surgery and angular malalignment were more frequent when the fibula was fixed. Therefore, such concomitant fibula fractures should not routinely be fixed and if stabilization is deemed necessary, the implant should be chosen carefully.

MIPO vs. intra-medullary nailing for extra-articular distal tibia fractures and the efficacy of intra-operative alignment control: a retrospective cohort of 135 patients.

INTRODUCTION: Definitive treatment of distal extra-articular fractures of the tibia is challenging and both minimal invasive plate osteosynthesis (MIPO) and intramedullary nailing (IMN) are considered to be feasible surgical modalities with their own implant-specific merits and demerits. This retrospective study was designed to compare MIPO versus IMN in terms of fracture healing, complications, functional and radiological outcomes and to assess the efficacy of intra-operative alignment control to reduce the rate of malalignment after definitive fixation of distal extra-articular fractures of the tibia. MATERIALS AND METHODS: All consecutive adult patients with extra-articular distal meta- or diaphyseal tibia fractures that were treated between January 2012 and September 2019 either with MIPO or IMN were included. Outcome measures included fracture healing, complications (infection, malalignment, subsequent surgeries), functional and radiological outcomes. Intra-operative alignment control encompassed bilateral draping of the lower extremities. RESULTS: A total of 135 patients were included out of which 72 patients (53%) were treated with MIPO and 63 patients (47%) underwent IMN. There was a significantly higher incidence of non-union for fractures treated with IMN (13 (22%) vs. 4 (6%), p = 0.04). There was no significant difference between both groups in terms of rotational malalignment (3% vs. 10%) and angular malalignment (4% vs. 5%). A significantly higher rate of infection was found after MIPO after correction of significant differences in baseline characteristics. No differences were found in subsequent surgeries or functional outcomes. CONCLUSION: Both MIPO and IMN are reliable surgical techniques. IMN is associated with higher rates of non-union, whereas MIPO results in a higher risk for infection. The incidence of malalignment was surprisingly low endorsing the utility of the intra-operative alignment control.

Difference in Pain, Complication Rates, and Clinical Outcomes After Suprapatellar Versus Infrapatellar Nailing for Tibia Fractures? A Systematic Review of 1447 Patients.

OBJECTIVES: To assess the effectiveness of suprapatellar (SP)-nailing versus infrapatellar (IP)-nailing of tibia fractures in anterior knee pain, complications (retropatellar chondropathy, infection, and malalignment) and physical functioning and quality of life. A clinical question-driven and thorough systematic review of current literature is provided. DATA SOURCE: PubMed and Embase databases were searched for studies published between 2010 and 2020 relating to SP and IP-nailing of tibia fractures. The study is performed in concordance with PRISMA-guidelines. STUDY SELECTION: Studies eligible for inclusion were randomized controlled trials, prospective and retrospective observational studies reporting on outcomes of interest. DATA EXTRACTION: Data extraction was performed independently by 2 assessors. Methodological quality and risk of bias was assessed according to the guidelines of the McMaster Critical Appraisal. DATA SYNTHESIS: Continuous variables are presented as means with SD and dichotomous variables as frequency and percentages. The weighted mean, standardized weighted mean differences, and 95% confidence interval were calculated. A pooled analysis could not be performed because of differences in outcome measures, time-points, and heterogeneity. RESULTS: Fourteen studies with 1447 patients were analyzed. The weighted incidence of anterior knee pain was 29% after SP-nailing and 39% after IP-nailing, without reported significance. There was a significant lower rate of malalignment after the SP-approach (4% vs. 26%) with small absolute differences in all planes. No substantial differences were observed in retropatellar chondropathy, infection, physical functioning, and quality of life. CONCLUSIONS: This systematic review does not reveal superiority of either technique in any of the respective outcomes of interest. Definitive choice should depend on the surgeon's experience and available resources. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Prevalence of Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures: Can We Reliably Use the Contralateral Uninjured Side as the Reference Standard?

BACKGROUND: Intramedullary (IM) nailing is the treatment of choice for most tibial shaft fractures. However, an iatrogenic pitfall may be rotational malalignment. The aims of this retrospective analysis were to determine (1) the prevalence of rotational malalignment using postoperative computed tomography (CT) as the reference standard; (2) the average baseline tibial torsion of uninjured limbs; and (3) based on that normal torsion, whether the contralateral, uninjured limb can be reliably used as the reference standard. METHODS: The study included 154 patients (71% male and 29% female) with a median age of 37 years. All patients were treated for a unilateral tibial shaft fracture with an IM nail and underwent low-dose bilateral postoperative CT to assess rotational malalignment. RESULTS: More than one-third of the patients (n = 55; 36%) had postoperative rotational malalignment of ≥10°. Right-sided tibial shaft fractures were significantly more likely to display external rotational malalignment whereas left-sided fractures were predisposed to internal rotational malalignment. The uninjured right tibiae were an average of 4° more externally rotated than the left (mean rotation and standard deviation, 41.1° ± 8.0° [right] versus 37.0° ± 8.2° [left]; p < 0.01). Applying this 4° correction to our cohort not only reduced the prevalence of rotational malalignment (n = 45; 29%), it also equalized the distribution of internal and external rotational malalignment between the left and right tibiae. CONCLUSIONS: This study confirms a high prevalence of rotational malalignment following IM nailing of tibial shaft fractures (36%). There was a preexisting 4° left-right difference in tibial torsion, which sheds a different light on previous studies and current clinical practice and could have important implications for the diagnosis and management of tibial rotational malalignment. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Bilateral Low-Dose Computed Tomography Assessment for Post-Operative Rotational Malalignment After Intramedullary Nailing for Tibial Shaft Fractures: Reliability of a Practical Imaging Technique.

INTRODUCTION: The purpose of this study is to evaluate the intra- and inter-observer reliability of low-dose protocolled bilateral postoperative Computed Tomography (CT)-assessment of rotational malalignment after intramedullary nailing (IMN) of tibial shaft fractures. MATERIALS AND METHODS: 156 patients were prospectively included with tibial shaft fractures that were treated with IMN in a Level-I Trauma Centre. All patients underwent post-operative bilateral low-dose CT-assessment (effective dose of 0.03784 - 0.05768 mGy) as per hospital protocol. Four observers performed the validated reproducible measurements of tibial torsion in degrees, based on standardized techniques. The Intra-Class Coefficient (ICC) was calculated to evaluate intra- and inter-observer reliability. The intra- and inter-observer reliability was categorized according to Landis and Koch. RESULTS: Intra-observer reliability for quantification of rotational malalignment on post-operative CT after IMN of tibial shaft fractures was excellent with 0.95 (95% CI = 0.92-0.97). The overall inter-observer reliability was 0.90 (95% CI = 0.87-0.92), also excellent according Landis and Koch. CONCLUSION: Firstly, bilateral post-operative low-dose -similar radiation exposure as plain chest radiographs- CT assessment of tibial rotational alignment is a reliable diagnostic imaging modality to assess rotational malalignment in patients following IMN of tibial shaft fractures and it allows for early revision surgery. Secondly, it may contribute to our understanding of the incidence-, predictors- and clinical relevance of post-operative tibial rotational malalignment in patients treated with IMN for a tibial shaft fracture, and facilitates future studies on this topic.