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Bone & Joint Research
Vol. 13, Issue 12 | Pages 790 - 792
17 Dec 2024
Mangwani J Brockett C Pegg E

Cite this article: Bone Joint Res 2024;13(12):790–792.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 2 - 2
12 Dec 2024
Goel A Bidwai R Singh V Malaviya S Kumar K Cairns D Barker S Khan K
Full Access

Objective. We aimed to analyse the clinical outcomes and survivorship of anatomic total shoulder arthroplasty using a stemless humeral component with cemented pegged polyethylene glenoid performed with the technique of eccentric reaming to partially correct retroversion. These results were then compared with TSA using the same implant for end-stage shoulder arthritis with a normal version of the native glenoid. Design and methods. A retrospective case series was performed using a prospectively collected database of anatomic TSA patients operated at Woodend General Hospital, Aberdeen, UK. Between 2010 and 2019, 107 total shoulder arthroplasties (TSA) were done using standard anatomic stemless TSA implants (Affinis Short, Mathys Ltd, Bettlach, Switzerland) in 98 patients. Standardized preoperative and postoperative shoulder radiological imaging for glenoid retroversion was collected. Depending on the angle of native glenoid version, patients were divided into retroverted and non-retroverted glenoid as per the Walch Classification. To assess the radiological outcome at the final follow-up, radiolucency was assessed on the glenoid and humeral side using the Lazarus grading. The final clinical and radiologic outcome from the retroverted group was compared with the population with a non-retroverted glenoid. Five TSAs were excluded from the analysis as they did not have satisfactory postoperative radiographs. Hence, a total of 102 shoulders were available for analysis. Results. The mean follow-up was 3.48 years (2-10.2 years) in the retroverted group (n=44) and 3.9 years (2-8.9 years) in the non-retroverted group (n=58). The mean pre-operative retroversion of the glenoid in the retroverted group was 20.18, and the post-operative retroversion was 15.87, with a mean correction of 4.31. There was no significant difference between the two groups in the percentage of radiological loosening. The mean Oxford shoulder score was 41.4 (16-48) in the retroverted group, while it was 42.1 (20-48) in the non-retroverted group. Three patients in the retroverted group required revision surgery for rotator cuff failure. There were no revisions for aseptic loosening or instability. Conclusion. The degree of severity of retroversion of the glenoid was not associated with poor clinical outcomes, revisions, or failure in stemless TSA. At medium-term follow-up, partial correction of retroversion seems to provide comparable outcomes compared to a non-retroverted glenoid


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 7 - 7
12 Dec 2024
Shah D Shah A
Full Access

Introduction. Instability in ACL deficient knees can lead to medial compartment osteoarthritis. The risk of developing significant OA is 5x higher in knees with ACL deficiency. In associated Varus, there is quicker progression of the medial OA along with a varus thrust exerting strain on the ACL graft. The simultaneous valgus HTO and ACL reconstruction decompresses the medial tibiofemoral joint, corrects the mechanical-axis and reduces strain on the graft. Outcomes for this simultaneous procedure are still unclear in literature and we attempt evaluating its functional outcome. Methods. This Panel study was performed using data from 2019 to 2022 on 21 patients who had ACL insufficiency with Varus or medial OA and underwent a simultaneous Opening-wedge HTO with Arthroscopic ACL reconstruction. The mean follow-up was 2 years. The patients were evaluated with IKDC and Lysholm scores, Lachman test and ROM pre and post-operatively. The HKA was compared pre and post-operatively and the complications were evaluated. The progression of OA was evaluated with serial radiographs post-operatively. Results. There was a significant improvement in lifestyle and knee joint function post-operatively. The mechanical femorotibial angle was corrected from an average of 8.2° Varus to 0.8° Valgus. There was a significant improvement in IKDC and Lysholm scoring (IKDC score improved to 86.20 from 34.48 and the Lysholm score improved to 89 points from 37 points). There was significant improvement in the laxity which was evaluated by Lachman test. One patient had a clinical progression of medial-OA. No patients had non-union, graft or implant failure. Conclusion. Single stage HTO and ACL Reconstruction in patients with medial OA or Varus with ACL insufficiency is an option showing a satisfactory functional and radiological outcome along with activity scores


Aims

Functional alignment (FA) in total knee arthroplasty (TKA) aims to achieve balanced gaps by adjusting implant positioning while minimizing changes to constitutional joint line obliquity (JLO). Although FA uses kinematic alignment (KA) as a starting point, the final implant positions can vary significantly between these two approaches. This study used the Coronal Plane Alignment of the Knee (CPAK) classification to compare differences between KA and final FA positions.

Methods

A retrospective analysis compared pre-resection and post-implantation alignments in 2,116 robotic-assisted FA TKAs. The lateral distal femoral angle (LDFA) and medial proximal tibial angle (MPTA) were measured to determine the arithmetic hip-knee-ankle angle (aHKA = MPTA – LDFA), JLO (JLO = MPTA + LDFA), and CPAK type. The primary outcome was the proportion of knees that varied ≤ 2° for aHKA and ≤ 3° for JLO from their KA to FA positions, and direction and magnitude of those changes per CPAK phenotype. Secondary outcomes included proportion of knees that maintained their CPAK phenotype, and differences between sexes.


Bone & Joint Research
Vol. 13, Issue 12 | Pages 725 - 740
5 Dec 2024
Xing J Liu S

Addressing bone defects is a complex medical challenge that involves dealing with various skeletal conditions, including fractures, osteoporosis (OP), bone tumours, and bone infection defects. Despite the availability of multiple conventional treatments for these skeletal conditions, numerous limitations and unresolved issues persist. As a solution, advancements in biomedical materials have recently resulted in novel therapeutic concepts. As an emerging biomaterial for bone defect treatment, graphene oxide (GO) in particular has gained substantial attention from researchers due to its potential applications and prospects. In other words, GO scaffolds have demonstrated remarkable potential for bone defect treatment. Furthermore, GO-loaded biomaterials can promote osteoblast adhesion, proliferation, and differentiation while stimulating bone matrix deposition and formation. Given their favourable biocompatibility and osteoinductive capabilities, these materials offer a novel therapeutic avenue for bone tissue regeneration and repair. This comprehensive review systematically outlines GO scaffolds’ diverse roles and potential applications in bone defect treatment.

Cite this article: Bone Joint Res 2024;13(12):725–740.


Bone & Joint Research
Vol. 13, Issue 12 | Pages 716 - 724
4 Dec 2024
Cao S Chen Y Zhu Y Jiang S Yu Y Wang X Wang C Ma X

Aims. This cross-sectional study aimed to investigate the in vivo ankle kinetic alterations in patients with concomitant chronic ankle instability (CAI) and osteochondral lesion of the talus (OLT), which may offer opportunities for clinician intervention in treatment and rehabilitation. Methods. A total of 16 subjects with CAI (eight without OLT and eight with OLT) and eight healthy subjects underwent gait analysis in a stair descent setting. Inverse dynamic analysis was applied to ground reaction forces and marker trajectories using the AnyBody Modeling System. One-dimensional statistical parametric mapping was performed to compare ankle joint reaction force and joint moment curve among groups. Results. The patients with OLT showed significantly increased dorsiflexion moment in the ankle joint compared with healthy subjects during 38.2% to 40.9% of the gait cycle, and increased eversion moment in the ankle joint compared with patients without OLT during 25.5% to 27.6% of the gait cycle. Compared with healthy subjects, the patients with OLT showed increased anterior force during 42% to 43% of the gait cycle, and maximal medial force (p = 0.005, ηp2 = 0.399). Conclusion. The patients with concomitant CAI and OLT exhibit increased dorsiflexion and eversion moment, as well as increased anterior and medial ankle joint reaction force during stair descent, compared with patients with CAI but without OLT and healthy subjects, respectively. Thus, a rehabilitative regimen targeting excessive ankle dorsiflexion and eversion moment may help to reduce ankle joint loading. Cite this article: Bone Joint Res 2024;13(12):716–724


Bone & Joint 360
Vol. 13, Issue 6 | Pages 26 - 29
1 Dec 2024

The December 2024 Wrist & Hand Roundup360 looks at: Variability in thumb ulnar collateral ligament rupture management across the UK: survey insights; Identifying five distinct hand osteoarthritis pain phenotypes highlights the impact of biopsychosocial factors; Long-term outcomes of MAÏA TMC joint prosthesis for osteoarthritis: a possible alternative to trapeziectomy; Diagnostic and management strategies for malignant melanoma of the hand; Early versus delayed surgery for distal radius fractures: comparable outcomes but higher complications in delayed treatment; Perioperative anticoagulant and antiplatelet use does not increase complications in wide-awake hand surgery; Variability in treatment of metacarpal shaft fractures highlights need for standardized care; Low-intensity pulsed ultrasound ineffective in reducing time to union for scaphoid nonunion post-surgery.


Bone & Joint 360
Vol. 13, Issue 6 | Pages 19 - 22
1 Dec 2024

The December 2024 Knee Roundup360 looks at: Unicompartmental knee arthroplasty and total knee arthroplasty in the same patient?; Lateral unicompartmental knee arthroplasty: is it a good option?; The fate of the unresurfaced patellae in contemporary total knee arthroplasty: early- to mid-term results; Tibial baseplate migration is not associated with change in PROMs and clinical scores after total knee arthroplasty; Unexpected positive intraoperative cultures in aseptic revision knee arthroplasty: what effect does this have?; Kinematic or mechanical alignment in total knee arthroplasty surgery?; Revision total knee arthroplasty achieves minimal clinically important difference faster than primary total knee arthroplasty; Outcomes after successful DAIR for periprosthetic joint infection in total knee arthroplasty.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1416 - 1425
1 Dec 2024
Stroobant L Jacobs E Arnout N Van Onsem S Tampere T Burssens A Witvrouw E Victor J

Aims

Approximately 10% to 20% of knee arthroplasty patients are not satisfied with the result, while a clear indication for revision surgery might not be present. Therapeutic options for these patients, who often lack adequate quadriceps strength, are limited. Therefore, the primary aim of this study was to evaluate the clinical effect of a novel rehabilitation protocol that combines low-load resistance training (LL-RT) with blood flow restriction (BFR).

Methods

Between May 2022 and March 2024, we enrolled 45 dissatisfied knee arthroplasty patients who lacked any clear indication for revision to this prospective cohort study. All patients were at least six months post-surgery and had undergone conventional physiotherapy previously. The patients participated in a supervised LL-RT combined with BFR in 18 sessions. Primary assessments included the following patient-reported outcome measures (PROMs): Knee injury and Osteoarthritis Outcome Score (KOOS); Knee Society Score: satisfaction (KSSs); the EuroQol five-dimension five-level questionnaire (EQ-5D-5L); and the pain catastrophizing scale (PCS). Functionality was assessed using the six-minute walk Test (6MWT) and the 30-second chair stand test (30CST). Follow-up timepoints were at baseline, six weeks, three months, and six months after the start.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1399 - 1407
1 Dec 2024
Fujii M Tanaka S Kawano S Ueno M Nagamine S Mawatari M

Aims

This study aimed to determine clinical outcomes; relationships between postoperative anterior, lateral, and posterior acetabular coverage and joint survival; and prognostic factors for joint survival after transposition osteotomy of the acetabulum (TOA).

Methods

Data from 616 patients (800 hips) with hip dysplasia who underwent TOA between November 1998 and December 2019 were reviewed. The median follow-up period was 8.9 years (IQR 5 to 14). A medical notes review was conducted to collect demographic data, complications, and modified Harris Hip Score (mHHS). Radiological indicators of acetabular coverage included lateral centre-edge angle (LCEA), anterior wall index (AWI), and posterior wall index (PWI). The cumulative probability of TOA failure (progression to Tönnis grade 3 or conversion to total hip arthroplasty) was estimated using the Kaplan-Meier product-limited method. A multivariate Cox proportional hazards model was used to identify predictors for failure.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1469 - 1476
1 Dec 2024
Matsuo T Kanda Y Sakai Y Yurube T Takeoka Y Miyazaki K Kuroda R Kakutani K

Aims. Frailty has been gathering attention as a factor to predict surgical outcomes. However, the association of frailty with postoperative complications remains controversial in spinal metastases surgery. We therefore designed a prospective study to elucidate risk factors for postoperative complications with a focus on frailty. Methods. We prospectively analyzed 241 patients with spinal metastasis who underwent palliative surgery from June 2015 to December 2021. Postoperative complications were assessed by the Clavien-Dindo classification; scores of ≥ Grade II were defined as complications. Data were collected regarding demographics (age, sex, BMI, and primary cancer) and preoperative clinical factors (new Katagiri score, Frankel grade, performance status, radiotherapy, chemotherapy, spinal instability neoplastic score, modified Frailty Index-11 (mFI), diabetes, and serum albumin levels). Univariate and multivariate analyses were developed to identify risk factors for postoperative complications (p < 0.05). Results. Overall, 57 postoperative complications occurred in 47 of 241 (19.5%) patients. The most common complications were wound infection/dehiscence, urinary tract infection, and pneumonia. Univariate analysis identified preoperative radiotherapy (p = 0.028), mFI (p < 0.001), blood loss ≥ 500 ml (p = 0.016), and preoperative molecular targeted drugs (p = 0.030) as potential risk factors. From the receiver operating characteristic curve, the clinically optimal cut-off value of mFI was 0.27 (sensitivity, 46.8%; specificity, 79.9%). Multivariate analysis identified mFI ≥ 0.27 (odds ratio (OR) 2.94 (95% CI 1.44 to 5.98); p = 0.003) and preoperative radiotherapy (OR 2.11 (95% CI 1.00 to 4.46); p = 0.049) as significant risk factors. In particular, urinary tract infection (p = 0.012) and pneumonia (p = 0.037) were associated with mFI ≥ 0.27. Furthermore, the severity of postoperative complications was positively correlated with mFI (p < 0.001). Conclusion. The mFI is a useful tool to predict the incidence and the severity of postoperative complications in spinal metastases surgery. Cite this article: Bone Joint J 2024;106-B(12):1469–1476


Bone & Joint 360
Vol. 13, Issue 6 | Pages 30 - 33
1 Dec 2024

The December 2024 Shoulder & Elbow Roundup. 360. looks at: Predicting recurrence of instability after a primary traumatic anterior shoulder dislocation; Predictors of surgery and long-term outcomes in nonoperative management of full-thickness rotator cuff tears; Reverse shoulder arthroplasty viable despite acquired acromial compromise, but higher infection risk noted; LP-PRP reduces retear rates in rotator cuff repair but shows no functional outcome advantage; Long-term clinical outcomes of arthroscopic supraspinatus tendon repair using the single anchor tension band technique – minimum five-year follow-up; Arthroscopic stabilization for anterior shoulder dislocation shows low recurrence rates regardless of prior dislocations; ORIF outperforms arthroplasty for complex radial head fractures: mid-term outcomes; Routine use of surgical helmet systems may not reduce infection risk in shoulder arthroplasty


Bone & Joint 360
Vol. 13, Issue 6 | Pages 23 - 26
1 Dec 2024

The December 2024 Foot & Ankle Roundup. 360. looks at: Tibiotalar sector and lateral ankle instability; Isolated subtalar fusion and correction of progressive collapsing foot deformity; Diabetic control and postoperative complications following ankle fracture fixation; Are insoles of any benefit for plantar fasciitis?; Postoperative foot shape and patient-reported outcome following surgery for progressing collapsing foot deformity; Calcaneo-stop procedure for symptomatic flexible flatfoot in children


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1431 - 1442
1 Dec 2024
Poutoglidou F van Groningen B McMenemy L Elliot R Marsland D

Lisfranc injuries were previously described as fracture-dislocations of the tarsometatarsal joints. With advancements in modern imaging, subtle Lisfranc injuries are now more frequently recognized, revealing that their true incidence is much higher than previously thought. Injury patterns can vary widely in severity and anatomy. Early diagnosis and treatment are essential to achieve good outcomes. The original classification systems were anatomy-based, and limited as tools for guiding treatment. The current review, using the best available evidence, instead introduces a stability-based classification system, with weightbearing radiographs and CT serving as key diagnostic tools. Stable injuries generally have good outcomes with nonoperative management, most reliably treated with immobilization and non-weightbearing for six weeks. Displaced or comminuted injuries require surgical intervention, with open reduction and internal fixation (ORIF) being the most common approach, with a consensus towards bridge plating. While ORIF generally achieves satisfactory results, its effectiveness can vary, particularly in high-energy injuries. Primary arthrodesis remains niche for the treatment of acute injuries, but may offer benefits such as lower rates of post-traumatic arthritis and hardware removal. Novel fixation techniques, including suture button fixation, aim to provide flexible stabilization, which theoretically could improve midfoot biomechanics and reduce complications. Early findings suggest promising functional outcomes, but further studies are required to validate this method compared with established techniques. Future research should focus on refining stability-based classification systems, validation of weightbearing CT, improving rehabilitation protocols, and optimizing surgical techniques for various injury patterns to ultimately enhance patient outcomes.

Cite this article: Bone Joint J 2024;106-B(12):1431–1442.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1393 - 1398
1 Dec 2024
Morris WZ Haider S Hinds ST Podeszwa D Ellis H Osborne L Anable N Sucato D

Aims

There has been limited literature regarding outcomes of acetabular rim syndrome (ARS) with persistent acetabular os in the setting of acetabular dysplasia. The purpose of this study was to characterize a cohort of adolescent and young adult patients with ARS with persistent os and compare their radiological and clinical outcomes to patients with acetabular dysplasia without an os.

Methods

We reviewed a prospective database of patients undergoing periacetabular osteotomy (PAO) for symptomatic acetabular dysplasia between January 1999 and December 2021 to identify hips with preoperative os acetabuli, defined as a closed triradiate cartilage but persistence of a superolateral os acetabulum. A total of 14 hips in 12 patients with persistent os acetabuli (ARS cohort) were compared to 50 randomly selected ‘control’ hips without persistent os acetabuli. Preoperative and postoperative radiographs were measured for markers of dysplasia: lateral centre-edge angle, anterior centre-edge angle, acetabular inclination, and migration index. Union of the os was determined in patients with ≥ six months’ follow-up. Patient-reported outcome measures (PROMs) included the University of California, Los Angeles (UCLA) activity score and modified Harris Hip Score (mHHS, maximum score 80) completed at one year postoperatively.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1477 - 1484
1 Dec 2024
Wang Y Shen L Xie D Long H Chen H Wei J Zeng C Lei G

Aims

For displaced femoral neck fractures (FNFs) in geriatric patients, there remains uncertainty regarding the effect of total hip arthroplasty (THA) compared with hemiarthroplasty (HA) in the guidelines. We aimed to compare 90-day surgical readmission, in-hospital complications, and charges between THA and HA in these patients.

Methods

The Hospital Quality Monitoring System was queried from 1 January 2013 to 31 December 2019 for displaced FNFs in geriatric patients treated with THA or HA. After propensity score matching, which identified 33,849 paired patients, outcomes were compared between THA and HA using logistic and linear regression models.


Bone & Joint Research
Vol. 13, Issue 11 | Pages 682 - 693
26 Nov 2024
Wahl P Heuberger R Pascucci A Imwinkelried T Fürstner M Icken N Schläppi M Pourzal R Gautier E

Aims

Highly cross-linked polyethylene (HXLPE) greatly reduces wear in total hip arthroplasty, compared to conventional polyethylene (CPE). Cross-linking is commonly achieved by irradiation. This study aimed to compare the degree of cross-linking and in vitro wear rates across a cohort of retrieved and unused polyethylene cups/liners from various brands.

Methods

Polyethylene acetabular cups/liners were collected at one centre from 1 April 2021 to 30 April 2022. The trans-vinylene index (TVI) and oxidation index (OI) were determined by Fourier-transform infrared spectrometry. Wear was measured using a pin-on-disk test.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_19 | Pages 57 - 57
22 Nov 2024
Jiang Y Wang L
Full Access

Aim. This study seeks to outline the clinical, laboratory, and imaging features of patients with pyogenic spondylitis. It aims to define a novel imaging sign that could indicate the severity of suppurative spondylitis, aiding in its early diagnosis and treatment. Method. This retrospective study included 137 patients from 2013 to 2023. Through the analysis and summary of imaging characteristics among all patients, we identified a distinct MRI sign known as ‘the Disc Penetration sign’ (DP). This sign is defined as an image finding on sagittal MRI depicting the anterior and posterior penetration of an abscess through the intervertebral disc space, affecting both the anterior margin of the vertebrae and the structures within the spinal canal. Observational parameters included WBC, ESR, CRP, hemoglobin, and albumin levels. Documentation of the study included location and segment of the lesion, presence or absence of spinal cord compression, and paravertebral abscesses. Results. 56 patients presented with the Disc Penetration sign(DP) and 81 did not. In both groups, there were no significant differences in gender ratio or age (P > 0.05). However, significant differences were observed in the presence of comorbid diabetes and chronic kidney disease (p < 0.05). The DP group had a significantly greater ESR level (74.30±33.79 mm/h vs. 51.46±30.46 mm/h, P < 0.001) and CRP level (47.28 mg/L vs. 26.18 mg/L, P = 0.003). Additionally, the DP group had a significantly lower Hb (100.66±19.82 g/L vs. 116.99±19.99g/L,P < 0.001) and the serum albumin level (28.81±6.59 g/L vs. 34.09±6.17 g/L,P < 0.001). Imaging results showed no significant differences in affected spinal segments or parts (p>0.05). Patients in the DP group showed a higher likelihood of developing paravertebral abscesses compared to those in the non-DP group (n = 54 [96.4%] vs. n = 33 [40.7%], P < 0.001), and also exhibited a higher incidence of spinal cord compression(n = 32 [57.1%] vs. n = 17 [21.0%], P < 0.001). Conclusions. The study suggests that the Disc Penetration sign in pyogenic spondylitis patients correlates with more severe inflammation and higher incidence of paraspinal abscess, pointing to worse stability of the spine, longer bone restructuring time, and potentially poorer prognosis. These findings enable clinicians to rapidly assess the severity of the disease and prognosticate outcomes more effectively We emphasize the need for early, pathogen-specific diagnosis and treatment, particularly considering surgical intervention for patients demonstrating substantial paraspinal abscesses or spinal instability


Bone & Joint Open
Vol. 5, Issue 11 | Pages 1041 - 1048
19 Nov 2024
Delgado C Martínez-Rodríguez JM Candura D Valencia M Martínez-Catalán N Calvo E

Aims

The Bankart and Latarjet procedures are two of the most common surgical techniques to treat anterior shoulder instability with satisfactory clinical and functional outcomes. However, the outcomes in the adolescent population remain unclear, and there is no information regarding the arthroscopic Latarjet in this population. The purpose of this study was to evaluate the outcomes of the arthroscopic Bankart and arthroscopic Latarjet procedures in the management of anterior shoulder instability in adolescents.

Methods

We present a retrospective, matched-pair study of teenagers with anterior glenohumeral instability treated with an arthroscopic Bankart repair (ABR) or an arthroscopic Latarjet (AL) procedure with a minimum two-year follow-up. Preoperative demographic and clinical features, factors associated with dislocation, and complications were collected. Recurrence, defined as dislocation or subluxation, was established as the primary outcome. Clinical and functional outcomes were analyzed using objective (Rowe), and subjective (Western Ontario Shoulder Instability Index (WOSI) and Single Assessment Numeric Evaluation (SANE)) scores. Additionally, the rate of return to sport was assessed.


Bone & Joint Open
Vol. 5, Issue 11 | Pages 1037 - 1040
15 Nov 2024
Wu DY Lam EKF

Aims

The first metatarsal pronation deformity of hallux valgus feet is widely recognized. However, its assessment relies mostly on 3D standing CT scans. Two radiological signs, the first metatarsal round head (RH) and inferior tuberosity position (ITP), have been described, but are seldom used to aid in diagnosis. This study was undertaken to determine the reliability and validity of these two signs for a more convenient and affordable preoperative assessment and postoperative comparison.

Methods

A total of 200 feet were randomly selected from the radiograph archives of a foot and ankle clinic. An anteroposterior view of both feet was taken while standing on the same x-ray platform. The intermetatarsal angle (IMA), metatarsophalangeal angle (MPA), medial sesamoid position, RH, and ITP signs were assessed for statistical analysis.