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The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 3 | Pages 302 - 307
1 Mar 2012
Kadar T Furnes O Aamodt A Indrekvam K Havelin LI Haugan K Espehaug B Hallan G

In this prospective study we studied the effect of the inclination angle of the acetabular component on polyethylene wear and component migration in cemented acetabular sockets using radiostereometric analysis. A total of 120 patients received either a cemented Reflection All-Poly ultra-high-molecular-weight polyethylene or a cemented Reflection All-Poly highly cross-linked polyethylene acetabular component, combined with either cobalt–chrome or Oxinium femoral heads. Femoral head penetration and migration of the acetabular component were assessed with repeated radiostereometric analysis for two years. The inclination angle was measured on a standard post-operative anteroposterior pelvic radiograph. Linear regression analysis was used to determine the relationship between the inclination angle and femoral head penetration and migration of the acetabular component. We found no relationship between the inclination angle and penetration of the femoral head at two years’ follow-up (p = 0.9). Similarly, our data failed to reveal any statistically significant correlation between inclination angle and migration of these cemented acetabular components (p = 0.07 to p = 0.9)


The Bone & Joint Journal
Vol. 96-B, Issue 3 | Pages 312 - 318
1 Mar 2014
Meermans G Van Doorn WJ Koenraadt K Kats J

The orientation of the acetabular component can influence both the short- and long-term outcomes of total hip replacement (THR). We performed a prospective, randomised, controlled trial of two groups, comprising of 40 patients each, in order to compare freehand introduction of the component with introduction using the transverse acetabular ligament (TAL) as a reference for anteversion. Anteversion and inclination were measured on pelvic radiographs. With respect to anteversion, in the freehand group 22.5% of the components were outside the safe zone versus 0% in the transverse acetabular ligament group (p = 0.002). The mean angle of anteversion in the freehand group was 21° (2° to 35°) which was significantly higher compared with 17° (2° to 25°) in the TAL group (p = 0.004). There was a significant difference comparing the variations of both groups (p = 0.008). With respect to inclination, in the freehand group 37.5% of the components were outside the safe zone versus 20% in the TAL group (p = 0.14). There was no significant difference regarding the accuracy or variation of the angle of inclination when comparing the two groups. . The transverse acetabular ligament may be used to obtain the appropriate anteversion when introducing the acetabular component during THR, but not acetabular component inclination. . Cite this article: Bone Joint J 2014;96-B:312–18


The Bone & Joint Journal
Vol. 95-B, Issue 8 | Pages 1101 - 1105
1 Aug 2013
Haug LC Glodny B Deml C Lutz M Attal R

Penetration of the dorsal screw when treating distal radius fractures with volar locking plates is an avoidable complication that causes lesions of the extensor tendon in between 2% and 6% of patients. We examined axial fluoroscopic views of the distal end of the radius to observe small amounts of dorsal screw penetration, and determined the ideal angle of inclination of the x-ray beam to the forearm when making this radiological view. Six volar locking plates were inserted at the wrists of cadavers. The actual screw length was measured under direct vision through a dorsal approach to the distal radius. Axial radiographs were performed for different angles of inclination of the forearm at the elbow. Comparing axial radiological measurements and real screw length, a statistically significant correlation could be demonstrated at an angle of inclination between 5° and 20°. The ideal angle of inclination required to minimise the risk of implanting over-long screws in a dorsal horizon radiological view is 15°. Cite this article: Bone Joint J 2013;95-B:1101–5


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1704 - 1710
1 Dec 2016
Nakamura N Inaba Y Aota Y Oba M Machida J N. Aida Kurosawa K Saito T

Aims. To determine the normal values and usefulness of the C1/4 space available for spinal cord (SAC) ratio and C1 inclination angle, which are new radiological parameters for assessing atlantoaxial instability in children with Down syndrome. Patients and Methods. We recruited 272 children with Down syndrome (including 14 who underwent surgical treatment), and 141 children in the control group. All were aged between two and 11 years. The C1/4 SAC ratio, C1 inclination angle, atlas-dens interval (ADI), and SAC were measured in those with Down syndrome, and the C1/4 SAC ratio and C1 inclination angle were measured in the control group. Results. The mean C1/4 SAC ratio in those requiring surgery with Down syndrome, those with Down syndrome not requiring surgery and controls were 0.63 (standard deviation (. sd. ) 0.1), 1.15 (. sd . 0.13) and 1.29 (. sd. 0.14), respectively, and the mean C1 inclination angles were -3.1° (. sd.  10.7°), 15.8° (. sd. 7.3) and 17.2° (. sd. 7.3), in these three groups, respectively. The mean ADI and SAC in those with Down syndrome requiring surgery and those with Down syndrome not requiring surgery were 9.8 mm (. sd. 2.8) and 4.3 mm (. sd. 1.0), and 11.1 mm (. sd. 2.6) and 18.5 mm (. sd. 2.4), respectively. Conclusion. The normal values of the C1/4 SAC ratio and the C1 inclination angle were found to be about 1.2° and 15º, respectively. Cite this article: Bone Joint J 2016;98-B:1704–10


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1069 - 1073
1 Aug 2016
Stirling E Jeffery J Johnson N Dias J

Aims. The degree of displacement of a fracture of the distal radius is an important factor which can be assessed using simple radiographic measurements. Our aim was to investigate the reliability and reproducibility of these measurements and to determine if they should be used clinically. Patients and Methods. A 10% sample was randomly generated from 3670 consecutive adult patients who had presented to University Hospitals of Leicester NHS Trust between 2007 and 2010 with a fracture of the distal radius. Radiographs of the 367 patients were assessed by two independent reviewers. Four measurements of displacement of the fracture were recorded and the inter-observer correlation assessed using the intra-class correlation coefficient. Results. Inter-observer correlation was high (> 0.8) for three of the four measurements. Repeat measurements of a further randomly generated 10% sample (37) were made four weeks later to assess intra-observer agreement, which was again high (> 0.8) for the same three parameters (radial height, radial inclination and dorsal/palmar tilt). Correlation was poor for articular step and gap. Conclusion. Radiographic assessment of radial angle, radial inclination and dorsal/palmar tilt is a reliable method of determining the degree of displacement of a fracture of the distal radius. Cite this article: Bone Joint J 2016;98-B:1069–73


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1080 - 1085
1 Aug 2016
Gauci MO Boileau P Baba M Chaoui J Walch G

Aims. Patient-specific glenoid guides (PSGs) claim an improvement in accuracy and reproducibility of the positioning of components in total shoulder arthroplasty (TSA). The results have not yet been confirmed in a prospective clinical trial. Our aim was to assess whether the use of PSGs in patients with osteoarthritis of the shoulder would allow accurate and reliable implantation of the glenoid component. Patients and Methods. A total of 17 patients (three men and 14 women) with a mean age of 71 years (53 to 81) awaiting TSA were enrolled in the study. Pre- and post-operative version and inclination of the glenoid were measured on CT scans, using 3D planning automatic software. During surgery, a congruent 3D-printed PSG was applied onto the glenoid surface, thus determining the entry point and orientation of the central guide wire used for reaming the glenoid and the introduction of the component. Manual segmentation was performed on post-operative CT scans to compare the planned and the actual position of the entry point (mm) and orientation of the component (°). Results. The mean error in the accuracy of the entry point was -0.1 mm (standard deviation (. sd. ) 1.4) in the horizontal plane, and 0.8 mm (. sd. 1.3) in the vertical plane. The mean error in the orientation of the glenoid component was 3.4° (. sd. 5.1°) for version and 1.8° (. sd. 5.3°) for inclination. Conclusion. Pre-operative planning with automatic software and the use of PSGs provides accurate and reproducible positioning and orientation of the glenoid component in anatomical TSA. Cite this article: Bone Joint J 2016;98-B:1080–5


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 927 - 933
1 Jul 2017
Poltaretskyi S Chaoui J Mayya M Hamitouche C Bercik MJ Boileau P Walch G

Aims. Restoring the pre-morbid anatomy of the proximal humerus is a goal of anatomical shoulder arthroplasty, but reliance is placed on the surgeon’s experience and on anatomical estimations. The purpose of this study was to present a novel method, ‘Statistical Shape Modelling’, which accurately predicts the pre-morbid proximal humeral anatomy and calculates the 3D geometric parameters needed to restore normal anatomy in patients with severe degenerative osteoarthritis or a fracture of the proximal humerus. Materials and Methods. From a database of 57 humeral CT scans 3D humeral reconstructions were manually created. The reconstructions were used to construct a statistical shape model (SSM), which was then tested on a second set of 52 scans. For each humerus in the second set, 3D reconstructions of four diaphyseal segments of varying lengths were created. These reconstructions were chosen to mimic severe osteoarthritis, a fracture of the surgical neck of the humerus and a proximal humeral fracture with diaphyseal extension. The SSM was then applied to the diaphyseal segments to see how well it predicted proximal morphology, using the actual proximal humeral morphology for comparison. Results. With the metaphysis included, mimicking osteoarthritis, the errors of prediction for retroversion, inclination, height, radius of curvature and posterior and medial offset of the head of the humerus were 2.9° (± 2.3°), 4.0° (± 3.3°), 1.0 mm (± 0.8 mm), 0.8 mm (± 0.6 mm), 0.7 mm (± 0.5 mm) and 1.0 mm (± 0.7 mm), respectively. With the metaphysis excluded, mimicking a fracture of the surgical neck, the errors of prediction for retroversion, inclination, height, radius of curvature and posterior and medial offset of the head of the humerus were 3.8° (± 2.9°), 3.9° (± 3.4°), 2.4 mm (± 1.9 mm), 1.3 mm (± 0.9 mm), 0.8 mm (± 0.5 mm) and 0.9 mm (± 0.6 mm), respectively. Conclusion. This study reports a novel, computerised method that accurately predicts the pre-morbid proximal humeral anatomy even in challenging situations. This information can be used in the surgical planning and operative reconstruction of patients with severe degenerative osteoarthritis or with a fracture of the proximal humerus. Cite this article: Bone Joint J 2017;99-B:927–33


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 3 | Pages 315 - 320
1 Mar 2011
Hart AJ Ilo K Underwood R Cann P Henckel J Lewis A Cobb J Skinner J

We measured the orientation of the acetabular and femoral components in 45 patients (33 men, 12 women) with a mean age of 53.4 years (30 to 74) who had undergone revision of metal-on-metal hip resurfacings. Three-dimensional CT was used to measure the inclination and version of the acetabular component, femoral version and the horizontal femoral offset, and the linear wear of the removed acetabular components was measured using a roundness machine. We found that acetabular version and combined version of the acetabular and femoral components were weakly positively correlated with the rate of wear. The acetabular inclination angle was strongly positively correlated with the rate of wear. Femoral version was weakly negatively correlated with the rate of wear. Application of a threshold of > 5 μm/year for the rate of wear in order to separate the revisions into low or high wearing groups showed that more high wearing components were implanted outside Lewinnek’s safe zone, but that this was mainly due to the inclination of the acetabular component, which was the only parameter that significantly differed between the groups. We were unable to show that excess version of the acetabular component alone or combined with femoral version was associated with an increase in the rate of wear based on our assessment of version using CT


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 705 - 710
1 May 2015
Ozmeric A Yucens M Gultaç E Açar HI Aydogan NH Gül D Alemdaroglu KB

We hypothesised that the anterior and posterior walls of the body of the first sacral vertebra could be visualised with two different angles of inlet view, owing to the conical shape of the sacrum. Six dry male cadavers with complete pelvic rings and eight dry sacrums with K-wires were used to study the effect of canting (angling the C-arm) the fluoroscope towards the head in 5° increments from 10° to 55°. Fluoroscopic images were taken in each position. Anterior and posterior angles of inclination were measured between the upper sacrum and the vertical line on the lateral view. Three authors separately selected the clearest image for overlapping anterior cortices and the upper sacral canal in the cadaveric models. The dry bone and K-wire models were scored by the authors, being sure to check whether the K-wire was in or out. In the dry bone models the mean score of the relevant inlet position of the anterior or posterior inclination was 8.875 (standard deviation (. sd. ) 0.35), compared with the inlet position of the opposite inclination of –5.75 (. sd. 4.59). We found that two different inlet views should be used separately to evaluate the borders of the body of the sacrum using anterior and posterior inclination angles of the sacrum, during placement of iliosacral screws. Cite this article: Bone Joint J 2015;97-B:705–10


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1287 - 1295
1 Oct 2009
Langton DJ Sprowson AP Joyce TJ Reed M Carluke I Partington P Nargol AVF

There have been no large comparative studies of the blood levels of metal ions after implantation of commercially available hip resurfacing devices which have taken into account the effects of femoral size and inclination and anteversion of the acetabular component. We present the results in 90 patients with unilateral articular surface replacement (ASR) hip resurfacings (mean time to blood sampling 26 months) and 70 patients with unilateral Birmingham Hip Resurfacing (BHR) implants (mean time 47 months). The whole blood and serum chromium (Cr) and cobalt (Co) concentrations were inversely related to the size of the femoral component in both groups (p < 0.05). Cr and Co were more strongly influenced by the position of the acetabular component in the case of the ASR, with an increase in metal ions observed at inclinations > 45° and anteversion angles of < 10° and > 20°. These levels were only increased in the BHR group when the acetabular component was implanted with an inclination > 55°. A significant relationship was identified between the anteversion of the BHR acetabular component and the levels of Cr and Co (p < 0.05 for Co), with an increase observed at anteversion angles < 10° and > 20°. The median whole blood and serum Cr concentrations of the male ASR patients were significantly lower than those of the BHR men (p < 0.001). This indicates that reduced diametral clearance may equate to a reduction in metal ion concentrations in larger joints with satisfactory orientation of the acetabular component


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 10 | Pages 1401 - 1405
1 Oct 2006
Honl M Schwieger K Salineros M Jacobs J Morlock M Wimmer M

We compared the orientation of the acetabular component obtained by a conventional manual technique with that using five different navigation systems. Three surgeons carried out five implantations of an acetabular component with each navigation system, as well as manually, using an anatomical model. The orientation of the acetabular component, including inclination and anteversion, and its position was determined using a co-ordinate measuring machine. The variation of the orientation of the acetabular component was higher in the conventional group compared with the navigated group. One experienced surgeon took significantly less time for the procedure. However, his placement of the component was no better than that of the less experienced surgeons. Significantly better inclination and anteversion (p < 0.001 for both) were obtained using navigation. These parameters were not significantly different between the surgeons when using the conventional technique (p = 0.966). The use of computer navigation helps a surgeon to orientate the acetabular component with less variation regarding inclination and anteversion


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 597 - 603
1 May 2014
Nomura T Naito M Nakamura Y Ida T Kuroda D Kobayashi T Sakamoto T Seo H

Several radiological methods of measuring anteversion of the acetabular component after total hip replacement (THR) have been described. These studies used different definitions and reference planes to compare methods, allowing for misinterpretation of the results. We compared the reliability and accuracy of five current methods using plain radiographs (those of Lewinnek, Widmer, Liaw, Pradhan, and Woo and Morrey) with CT measurements, using the same definition and reference plane. We retrospectively studied the plain radiographs and CT scans in 84 hips of 84 patients who underwent primary THR. Intra- and inter-observer reliability were high for the measurement of inclination and anteversion with all methods on plain radiographs and CT scans. The measurements of inclination on plain radiographs were similar to the measurements using CT (p = 0.043). The mean difference between CT measurements was 0.6° (-5.9° to 6.8°). Measurements using Widmer’s method were the most similar to those using CT (p = 0.088), with a mean difference between CT measurements of -0.9° (-10.4° to 9.1°), whereas the other four methods differed significantly from those using CT (p < 0.001). This study has shown that Widmer’s method is the best for evaluating the anteversion of the acetabular component on plain radiographs. Cite this article: Bone Joint J 2014; 96-B:597–603


Bone & Joint Open
Vol. 5, Issue 6 | Pages 514 - 523
24 Jun 2024
Fishley W Nandra R Carluke I Partington PF Reed MR Kramer DJ Wilson MJ Hubble MJW Howell JR Whitehouse SL Petheram TG Kassam AM

Aims

In metal-on-metal (MoM) hip arthroplasties and resurfacings, mechanically induced corrosion can lead to elevated serum metal ions, a local inflammatory response, and formation of pseudotumours, ultimately requiring revision. The size and diametral clearance of anatomical (ADM) and modular (MDM) dual-mobility polyethylene bearings match those of Birmingham hip MoM components. If the acetabular component is satisfactorily positioned, well integrated into the bone, and has no surface damage, this presents the opportunity for revision with exchange of the metal head for ADM/MDM polyethylene bearings without removal of the acetabular component.

Methods

Between 2012 and 2020, across two centres, 94 patients underwent revision of Birmingham MoM hip arthroplasties or resurfacings. Mean age was 65.5 years (33 to 87). In 53 patients (56.4%), the acetabular component was retained and dual-mobility bearings were used (DM); in 41 (43.6%) the acetabulum was revised (AR). Patients underwent follow-up of minimum two-years (mean 4.6 (2.1 to 8.5) years).


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 268 - 276
1 Mar 2024
Park JH Lee JH Kim DY Kim HG Kim JS Lee SM Kim SC Yoo JC

Aims

This study aimed to assess the impact of using the metal-augmented glenoid baseplate (AGB) on improving clinical and radiological outcomes, as well as reducing complications, in patients with superior glenoid wear undergoing reverse shoulder arthroplasty (RSA).

Methods

From January 2016 to June 2021, out of 235 patients who underwent primary RSA, 24 received a superior-AGB after off-axis reaming (Group A). Subsequently, we conducted propensity score matching in a 1:3 ratio, considering sex, age, follow-up duration, and glenoid wear (superior-inclination and retroversion), and selected 72 well-balanced matched patients who received a standard glenoid baseplate (STB) after eccentric reaming (Group B). Superior-inclination, retroversion, and lateral humeral offset (LHO) were measured to assess preoperative glenoid wear and postoperative correction, as well as to identify any complications. Clinical outcomes were measured at each outpatient visit before and after surgery.


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 352 - 358
1 Apr 2024
Wilson JM Trousdale RT Bedard NA Lewallen DG Berry DJ Abdel MP

Aims

Dislocation remains a leading cause of failure following revision total hip arthroplasty (THA). While dual-mobility (DM) bearings have been shown to mitigate this risk, options are limited when retaining or implanting an uncemented shell without modular DM options. In these circumstances, a monoblock DM cup, designed for cementing, can be cemented into an uncemented acetabular shell. The goal of this study was to describe the implant survival, complications, and radiological outcomes of this construct.

Methods

We identified 64 patients (65 hips) who had a single-design cemented DM cup cemented into an uncemented acetabular shell during revision THA between 2018 and 2020 at our institution. Cups were cemented into either uncemented cups designed for liner cementing (n = 48; 74%) or retained (n = 17; 26%) acetabular components. Median outer head diameter was 42 mm. Mean age was 69 years (SD 11), mean BMI was 32 kg/m2 (SD 8), and 52% (n = 34) were female. Survival was assessed using Kaplan-Meier methods. Mean follow-up was two years (SD 0.97).


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 396 - 400
1 Mar 2013
Rhee SH Kim J Lee YH Gong HS Lee HJ Baek GH

The purpose of this study was to evaluate the risk of late displacement after the treatment of distal radial fractures with a locking volar plate, and to investigate the clinical and radiological factors that might correlate with re-displacement. From March 2007 to October 2009, 120 of an original cohort of 132 female patients with unstable fractures of the distal radius were treated with a volar locking plate, and were studied over a follow-up period of six months. In the immediate post-operative and final follow-up radiographs, late displacement was evaluated as judged by ulnar variance, radial inclination, and dorsal angulation. We also analysed the correlation of a variety of clinical and radiological factors with re-displacement. Ulnar variance was significantly overcorrected (p < 0.001) while radial inclination and dorsal angulation were undercorrected when compared statistically (p <  0.001) with the unaffected side in the immediate post-operative stage. During follow-up, radial shortening and dorsal angulation progressed statistically, but none had a value beyond the acceptable range. Bone mineral density measured at the proximal femur and the position of the screws in the subchondral region, correlated with slight progressive radial shortening, which was not clinically relevant. Volar locking plating of distal radial fractures is a reliable form of treatment without substantial late displacement. Cite this article: Bone Joint J 2013;95-B:396–400


Bone & Joint 360
Vol. 11, Issue 6 | Pages 26 - 30
1 Dec 2022

The December 2022 Wrist & Hand Roundup360 looks at: Anti-tumour necrosis factor therapy for early-stage Dupuytren’s disease; Patient experiences of scaphoid waist fractures and their treatment; Postoperative complications following open a1 pulley release for a trigger finger or thumb; How certain are findings in distal radius fractures: a systematic review of randomized controlled trials; Partial wrist denervation in wrist osteoarthritis: patient-reported outcomes and objective function; Dorsal bridge plating versus bridging external fixation for management of complex distal radius fractures; How is reduction lost in distal radius fractures in females aged 50 years and older; The HAND-Q: psychometrics of a new patient-reported outcome measure for clinical and research applications.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 898 - 906
1 Sep 2024
Kayani B Wazir MUK Mancino F Plastow R Haddad FS

Aims

The primary objective of this study was to develop a validated classification system for assessing iatrogenic bone trauma and soft-tissue injury during total hip arthroplasty (THA). The secondary objective was to compare macroscopic bone trauma and soft-tissues injury in conventional THA (CO THA) versus robotic arm-assisted THA (RO THA) using this classification system.

Methods

This study included 30 CO THAs versus 30 RO THAs performed by a single surgeon. Intraoperative photographs of the osseous acetabulum and periacetabular soft-tissues were obtained prior to implantation of the acetabular component, which were used to develop the proposed classification system. Interobserver and intraobserver variabilities of the proposed classification system were assessed.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 853 - 858
10 Nov 2023
Subbiah Ponniah H Logishetty K Edwards TC Singer GC

Aims

Metal-on-metal hip resurfacing (MoM-HR) has seen decreased usage due to safety and longevity concerns. Joint registries have highlighted the risks in females, smaller hips, and hip dysplasia. This study aimed to identify if reported risk factors are linked to revision in a long-term follow-up of MoM-HR performed by a non-designer surgeon.

Methods

A retrospective review of consecutive MoM hip arthroplasties (MoM-HRAs) using Birmingham Hip Resurfacing was conducted. Data on procedure side, indication, implant sizes and orientation, highest blood cobalt and chromium ion concentrations, and all-cause revision were collected from local and UK National Joint Registry records.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 696 - 704
1 Jul 2024
Barvelink B Reijman M Smidt S Miranda Afonso P Verhaar JAN Colaris JW

Aims

It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer fracture redisplacements and better one-year outcomes compared to plaster splinting.

Methods

In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure.