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Bone & Joint Open
Vol. 5, Issue 8 | Pages 652 - 661
8 Aug 2024
Taha R Davis T Montgomery A Karantana A

Aims

The aims of this study were to describe the epidemiology of metacarpal shaft fractures (MSFs), assess variation in treatment and complications following standard care, document hospital resource use, and explore factors associated with treatment modality.

Methods

A multicentre, cross-sectional retrospective study of MSFs at six centres in the UK. We collected and analyzed healthcare records, operative notes, and radiographs of adults presenting within ten days of a MSF affecting the second to fifth metacarpal between 1 August 2016 and 31 July 2017. Total emergency department (ED) attendances were used to estimate prevalence.


Bone & Joint 360
Vol. 13, Issue 4 | Pages 37 - 40
2 Aug 2024

The August 2024 Children’s orthopaedics Roundup360 looks at: Antibiotic prophylaxis and infection rates in paediatric supracondylar humerus fractures; Clinical consensus recommendations for the non-surgical treatment of children with Perthes’ disease in the UK; Health-related quality of life in idiopathic toe walkers: a multicentre prospective cross-sectional study; Children with spinal dysraphism: a systematic review of reported outcomes; No delay in age of crawling, standing, or walking with Pavlik harness treatment: a prospective cohort study; No value found with routine early postoperative radiographs after implant removal in paediatric patients; What do we know about the natural history of spastic hip dysplasia and pain in total-involvement cerebral palsy?; Evaluating the efficacy and safety of preoperative gallows traction for hip open reduction in infants


Bone & Joint 360
Vol. 13, Issue 4 | Pages 16 - 19
2 Aug 2024

The August 2024 Knee Roundup360 looks at: Calcification’s role in knee osteoarthritis: implications for surgical decision-making; Lower complication rates and shorter lengths of hospital stay with technology-assisted total knee arthroplasty; Revision surgery: the hidden burden on surgeons; Are preoperative weight loss interventions worthwhile?; Total knee arthroplasty with or without prior bariatric surgery: a systematic review and meta-analysis; Aspirin triumphs in knee arthroplasty: a decade of evidence; Efficacy of DAIR in unicompartmental knee arthroplasty: a glimpse from Oxford.


Bone & Joint Open
Vol. 5, Issue 8 | Pages 628 - 636
2 Aug 2024
Eachempati KK Parameswaran A Ponnala VK Sunil A Sheth NP

Aims

The aims of this study were: 1) to describe extended restricted kinematic alignment (E-rKA), a novel alignment strategy during robotic-assisted total knee arthroplasty (RA-TKA); 2) to compare residual medial compartment tightness following virtual surgical planning during RA-TKA using mechanical alignment (MA) and E-rKA, in the same set of osteoarthritic varus knees; 3) to assess the requirement of soft-tissue releases during RA-TKA using E-rKA; and 4) to compare the accuracy of surgical plan execution between knees managed with adjustments in component positioning alone, and those which require additional soft-tissue releases.

Methods

Patients who underwent RA-TKA between January and December 2022 for primary varus osteoarthritis were included. Safe boundaries for E-rKA were defined. Residual medial compartment tightness was compared following virtual surgical planning using E-rKA and MA, in the same set of knees. Soft-tissue releases were documented. Errors in postoperative alignment in relation to planned alignment were compared between patients who did (group A) and did not (group B) require soft-tissue releases.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 775 - 782
1 Aug 2024
Wagner M Schaller L Endstrasser F Vavron P Braito M Schmaranzer E Schmaranzer F Brunner A

Aims

Hip arthroscopy has gained prominence as a primary surgical intervention for symptomatic femoroacetabular impingement (FAI). This study aimed to identify radiological features, and their combinations, that predict the outcome of hip arthroscopy for FAI.

Methods

A prognostic cross-sectional cohort study was conducted involving patients from a single centre who underwent hip arthroscopy between January 2013 and April 2021. Radiological metrics measured on conventional radiographs and magnetic resonance arthrography were systematically assessed. The study analyzed the relationship between these metrics and complication rates, revision rates, and patient-reported outcomes.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 842 - 848
1 Aug 2024
Kriechling P Whitefield R Makaram NS Brown IDM Mackenzie SP Robinson CM

Aims

Vascular compromise due to arterial injury is a rare but serious complication of a proximal humeral fracture. The aims of this study were to report its incidence in a large urban population, and to identify clinical and radiological factors which are associated with this complication. We also evaluated the results of the use of our protocol for the management of these injuries.

Methods

A total of 3,497 adult patients with a proximal humeral fracture were managed between January 2015 and December 2022 in a single tertiary trauma centre. Their mean age was 66.7 years (18 to 103) and 2,510 (72%) were female. We compared the demographic data, clinical features, and configuration of those whose fracture was complicated by vascular compromise with those of the remaining patients. The incidence of vascular compromise was calculated from national population data, and predictive factors for its occurrence were investigated using univariate analysis.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 783 - 791
1 Aug 2024
Tanaka S Fujii M Kawano S Ueno M Nagamine S Mawatari M

Aims. The aim of this study was to determine the clinical outcomes and factors contributing to failure of transposition osteotomy of the acetabulum (TOA), a type of spherical periacetabular osteotomy, for advanced osteoarthritis secondary to hip dysplasia. Methods. We reviewed patients with Tönnis grade 2 osteoarthritis secondary to hip dysplasia who underwent TOA between November 1998 and December 2019. Patient demographic details, osteotomy-related complications, and the modified Harris Hip Score (mHHS) were obtained via medical notes review. Radiological indicators of hip dysplasia were assessed using preoperative and postoperative radiographs. 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 of failure. Results. This study included 127 patients (137 hips). Median follow-up period was ten years (IQR 6 to 15). The median mHHS improved from 59 (IQR 52 to 70) preoperatively to 90 (IQR 73 to 96) at the latest follow-up (p < 0.001). The survival rate was 90% (95% CI 82 to 95) at ten years, decreasing to 21% (95% CI 7 to 48) at 20 years. Fair joint congruity on preoperative hip abduction radiographs and a decreased postoperative anterior wall index (AWI) were identified as independent risk factors for failure. The survival rate for the 42 hips with good preoperative joint congruity and a postoperative AWI ≥ 0.30 was 100% at ten years, and remained at 83% (95% CI 38 to 98) at 20 years. Conclusion. Although the overall clinical outcomes of TOA in patients with advanced osteoarthritis are suboptimal, favourable results can be achieved in selected cases with good preoperative joint congruity and adequate postoperative anterior acetabular coverage. Cite this article: Bone Joint J 2024;106-B(8):783–791


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Introduction. Developmental dysplasia of the hip (DDH) can be managed through a variety of different surgical approaches from closed reduction to simple tenotomies of the adductors and through to osteotomies of the femur and pelvis. The rate of redislocation following open reduction for the treatment of DDH may be affected by the number of intraoperative surgeons. Materials and methods. We performed a retrospective cohort analysis of 109 patients who underwent open reduction with or without bony osteotomies as a primary intervention between 2013 and 2023. We measured the number of redislocations and number of operating surgeons (either 1 or 2 operating surgeons) to assess for any correlation. 109 patients were identified and corresponded to 121 primary hip operations, the mean age at operation was 82.2 months (range 6 to 739 months). During the 10-year period 7 hip redislocations were identified. Results. Of the 7 redislocated hips, the rate of redislocation was found to be higher in patients who had undergone surgery via a single surgeon (5 redislocations) compared to the dual surgeon cohort (2 redislocations), though this did not reach statistical significance. Redislocation was more common in female patients and right laterality 7.2% and 8.7% respectively, though this again did not reach statistical significance. Conclusions. We conclude that a single surgeon approach, female gender and right laterality are potential risk factors for redislocation following open reduction. Further investigation utilising a larger sample size would be required to appropriately explore these potential risk factors further


Bone & Joint Open
Vol. 5, Issue 7 | Pages 581 - 591
12 Jul 2024
Wang W Xiong Z Huang D Li Y Huang Y Guo Y Andreacchio A Canavese F Chen S

Aims

To investigate the risk factors for unsuccessful radial head reduction (RHR) in children with chronic Monteggia fractures (CMFs) treated surgically.

Methods

A total of 209 children (mean age 6.84 years (SD 2.87)), who underwent surgical treatment for CMFs between March 2015 and March 2023 at six institutions, were retrospectively reviewed. Assessed risk factors included age, sex, laterality, dislocation direction and distance, preoperative proximal radial metaphysis width, time from injury to surgery, reduction method, annular ligament reconstruction, radiocapitellar joint fixation, ulnar osteotomy, site of ulnar osteotomy, preoperative and postoperative ulnar angulation, ulnar fixation method, progressive ulnar distraction, and postoperative cast immobilization. Independent-samples t-test, chi-squared test, and logistic regression analysis were used to identify the risk factors associated with unsuccessful RHR.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 751 - 758
1 Jul 2024
Yaxier N Zhang Y Song J Ning B

Aims

Given the possible radiation damage and inaccuracy of radiological investigations, particularly in children, ultrasound and superb microvascular imaging (SMI) may offer alternative methods of evaluating new bone formation when limb lengthening is undertaken in paediatric patients. The aim of this study was to assess the use of ultrasound combined with SMI in monitoring new bone formation during limb lengthening in children.

Methods

In this retrospective cohort study, ultrasound and radiograph examinations were performed every two weeks in 30 paediatric patients undergoing limb lengthening. Ultrasound was used to monitor new bone formation. The number of vertical vessels and the blood flow resistance index were compared with those from plain radiographs.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 735 - 743
1 Jul 2024
Gelfer Y Cavanagh SE Bridgens A Ashby E Bouchard M Leo DG Eastwood DM

Aims. There is a lack of high-quality research investigating outcomes of Ponseti-treated idiopathic clubfeet and correlation with relapse. This study assessed clinical and quality of life (QoL) outcomes using a standardized core outcome set (COS), comparing children with and without relapse. Methods. A total of 11 international centres participated in this institutional review board-approved observational study. Data including demographics, information regarding presentation, treatment, and details of subsequent relapse and management were collected between 1 June 2022 and 30 June 2023 from consecutive clinic patients who had a minimum five-year follow-up. The clubfoot COS incorporating 31 parameters was used. A regression model assessed relationships between baseline variables and outcomes (clinical/QoL). Results. Overall, 293 patients (432 feet) with a median age of 89 months (interquartile range 72 to 113) were included. The relapse rate was 37%, with repeated relapse in 14%. Treatment considered a standard part of the Ponseti journey (recasting, repeat tenotomy, and tibialis anterior tendon transfer) was performed in 35% of cases, with soft-tissue release and osteotomies in 5% and 2% of cases, respectively. Predictors of relapse included duration of follow-up, higher initial Pirani score, and poor Evertor muscle activity. Relapse was associated with poorer outcomes. Conclusion. This is the first multicentre study using a standardized COS following clubfoot treatment. It distinguishes patients with and without relapse in terms of clinical outcomes and QoL, with poorer outcomes in the relapse group. This tool allows comparison of treatment methods and outcomes, facilitates information sharing, and sets family expectations. Predictors of relapse encourage us to create appropriate treatment pathways to reduce relapse and improve outcome. Cite this article: Bone Joint J 2024;106-B(7):735–743


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.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 713 - 719
1 Jul 2024
Patel MS Shah S Elkazaz MK Shafafy M Grevitt MP

Aims

Historically, patients undergoing surgery for adolescent idiopathic scoliosis (AIS) have been nursed postoperatively in a critical care (CC) setting because of the challenges posed by prone positioning, extensive exposures, prolonged operating times, significant blood loss, major intraoperative fluid shifts, cardiopulmonary complications, and difficulty in postoperative pain management. The primary aim of this paper was to determine whether a scoring system, which uses Cobb angle, forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and number of levels to be fused, is a valid method of predicting the need for postoperative critical care in AIS patients who are to undergo scoliosis correction with posterior spinal fusion (PSF).

Methods

We retrospectively reviewed all AIS patients who had undergone PSF between January 2018 and January 2020 in a specialist tertiary spinal referral centre. All patients were assessed preoperatively in an anaesthetic clinic. Postoperative care was defined as ward-based (WB) or critical care (CC), based on the preoperative FEV1, FVC, major curve Cobb angle, and the planned number of instrumented levels.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 646 - 655
1 Jul 2024
Longo UG Gulotta LV De Salvatore S Lalli A Bandini B Giannarelli D Denaro V

Aims

Proximal humeral fractures are the third most common fracture among the elderly. Complications associated with fixation include screw perforation, varus collapse, and avascular necrosis of the humeral head. To address these challenges, various augmentation techniques to increase medial column support have been developed. There are currently no recent studies that definitively establish the superiority of augmented fixation over non-augmented implants in the surgical treatment of proximal humeral fractures. The aim of this systematic review and meta-analysis was to compare the outcomes of patients who underwent locking-plate fixation with cement augmentation or bone-graft augmentation versus those who underwent locking-plate fixation without augmentation for proximal humeral fractures.

Methods

The search was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Articles involving patients with complex proximal humeral fractures treated using open reduction with locking-plate fixation, with or without augmentation, were considered. A meta-analysis of comparative studies comparing locking-plate fixation with cement augmentation or with bone-graft augmentation versus locking-plate fixation without augmentation was performed.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 680 - 687
1 Jul 2024
Mancino F Fontalis A Grandhi TSP Magan A Plastow R Kayani B Haddad FS

Aims

Robotic arm-assisted surgery offers accurate and reproducible guidance in component positioning and assessment of soft-tissue tensioning during knee arthroplasty, but the feasibility and early outcomes when using this technology for revision surgery remain unknown. The objective of this study was to compare the outcomes of robotic arm-assisted revision of unicompartmental knee arthroplasty (UKA) to total knee arthroplasty (TKA) versus primary robotic arm-assisted TKA at short-term follow-up.

Methods

This prospective study included 16 patients undergoing robotic arm-assisted revision of UKA to TKA versus 35 matched patients receiving robotic arm-assisted primary TKA. In all study patients, the following data were recorded: operating time, polyethylene liner size, change in haemoglobin concentration (g/dl), length of inpatient stay, postoperative complications, and hip-knee-ankle (HKA) alignment. All procedures were performed using the principles of functional alignment. At most recent follow-up, range of motion (ROM), Forgotten Joint Score (FJS), and Oxford Knee Score (OKS) were collected. Mean follow-up time was 21 months (6 to 36).


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 662 - 668
1 Jul 2024
Ahmed I Metcalfe A

Aims. This study aims to identify the top unanswered research priorities in the field of knee surgery using consensus-based methodology. Methods. Initial research questions were generated using an online survey sent to all 680 members of the British Association for Surgery of the Knee (BASK). Duplicates were removed and a longlist was generated from this scoping exercise by a panel of 13 experts from across the UK who provided oversight of the process. A modified Delphi process was used to refine the questions and determine a final list. To rank the final list of questions, each question was scored between one (low importance) and ten (high importance) in order to produce the final list. Results. This consensus exercise took place between December 2020 and April 2022. A total of 286 clinicians from the BASK membership provided input for the initial scoping exercise, which generated a list of 105 distinct research questions. Following review and prioritization, a longlist of 51 questions was sent out for two rounds of the Delphi process. A total of 42 clinicians responded to the first round and 24 responded to the second round. A final list of 24 research questions was then ranked by 36 clinicians. The topics included arthroplasty, infection, meniscus, osteotomy, patellofemoral, cartilage, and ligament pathologies. The management of early osteoarthritis was the highest-ranking question. Conclusion. A Delphi exercise involving the BASK membership has identified the future research priorities in knee surgery. This list of questions will allow clinicians, researchers, and funders to collaborate in order to deliver high-quality research in knee surgery and further advance the care provided to patients with knee pathology. Cite this article: Bone Joint J 2024;106-B(7):662–668


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 744 - 750
1 Jul 2024
Saeed A Bradley CS Verma Y Kelley SP

Aims

Radiological residual acetabular dysplasia (RAD) has been reported in up to 30% of children who had successful brace treatment of infant developmental dysplasia of the hip (DDH). Predicting those who will resolve and those who may need corrective surgery is important to optimize follow-up protocols. In this study we have aimed to identify the prevalence and predictors of RAD at two years and five years post-bracing.

Methods

This was a single-centre, prospective longitudinal cohort study of infants with DDH managed using a published, standardized Pavlik harness protocol between January 2012 and December 2016. RAD was measured at two years’ mean follow-up using acetabular index-lateral edge (AI-L) and acetabular index-sourcil (AI-S), and at five years using AI-L, AI-S, centre-edge angle (CEA), and acetabular depth ratio (ADR). Each hip was classified based on published normative values for normal, borderline (1 to 2 standard deviations (SDs)), or dysplastic (> 2 SDs) based on sex, age, and laterality.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 16 - 16
17 Jun 2024
Sayani J Tiruveedhula M
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Aim. Forefoot ulcers in patients with diabetic neuropathy are a result of factors that result in increased forefoot plantar pressures. Progressive hindfoot equinus from contraction of gastrocnemius-soleus-tendo-Achilles complex and progressive plantar flexed metatarsal heads secondary to claw toe deformity results callus at the metatarsal heads which break down to ulceration. The aim is to describe 2-stage treatment pathway for managing these ulcers. Methods. Consecutive patients, who presented with forefoot ulcers since February 2019 were treated with a 2-stage treatment pathway. The first stage of this is an out-patient tendo-Achilles lengthening (TAL). The second stage is surgical proximal dorsal closing wedge metatarsal osteotomy for patients with persistent or recurrent ulcers. Patients were followed for a minimum of 12 months. Results. 112 patients (146 feet) underwent TAL by 3 consultants. Of these, 96 patients were followed for a minimum of 12 months (range 12–36 months). None had infection or wound related problems at the tenotomy sites; complete transection of the tendon was noted in 4 patients (4%) and one-patient developed heel callosity suggestive of over-lengthening. In 92 patients (96%), the ulcers healed within 10 weeks (± 4 weeks). Additional z-lengthening of peroneal longus and tibialis posterior tendons helped in patients with 1. st. metatarsal and 5. th. metatarsal head ulcers respectively. In 12 patients (10%), the ulcer failed to heal or recurred. MRI scan in these patients showed plantar flexed metatarsals from progressive claw toe deformity. The ulcer in this group healed after surgical offloading with proximal dorsal closing wedge osteotomy of the metatarsal/s, with no recurrence at a minimum 12months of follow-up. Conclusion. The described 2-stage treatment pathway results in long-term healing of neuropathic forefoot ulcers, and in 96% of patients, the ulcer healed after the first stage out-patient percutaneous TAL


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 13 - 13
10 Jun 2024
Kosa P Ahluwalia R Reichert I
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Introduction. Charcot neuroarthropathy is a debilitating condition that frequently leads to skeletal instability, and has an increased risk of ulceration leading to infection and amputation. However, surgical reconstruction may offer limb salvage and restauration of an ulcer-free, plantigrade stable foot for functional weight-bearing. We report on our case series according to a prospective protocol and analyse factors leading to a favourable outcome. Methods. We report a prospective follow-up of 62 patients undergoing Charcot reconstruction, May 2014- Jan 2022, by two surgeons. Peripheral vascular disease was routinely assessed using Duplex scan and major arterial disease was treated before reconstruction. Utilising 3D modelling, pre-operative planning and standardised osteotomies, we performed anatomical correction with radiological evidence. Definitive fixation was undertaken with internal fixation to stabilise the hindfoot. Multivariant analysis was performed to assess risk factors for failure (P>0.05 statistical significance). Results. 59 feet were included, 3 patients did not progress to definitive surgery and 3 patients had bilateral surgery. 62.7% patients were male with an average age of 56, 88.13% had Type 2 diabetes, 56% were hypertensive, 14% were on dialysis. Twenty (54.1%) single stage reconstructions had pre-operative ulceration, 3 pts had ischaemic heart disease and 36 pts had evidence of peripheral arterial disease. 81% of patients achieved normalisation of the 3 out of 4 anatomical angles (P<0.05). Two patients (3.1%) required metalwork removal for infection and limb salvage, 11 (18.6%) had delayed wound healing. Survivorship was 97% at 3yrs, and 94% at 6yrs, however if pre-existing vascular disease was present, it was 94% at 3yrs 85.3% at 6yrs. All patients were mobile at a 3 years mean follow up. Conclusion. Careful patient selection, multidisciplinary team and anatomic reconstruction led to predictable outcomes and functional limb salvage. Pre-operative vascular compromise led to a slight reduction in survivorship, but no major amputation


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 14 - 14
10 Jun 2024
Nogdallah S Fatooh M Khairy A Mohamed H Abdulrahman A Mohamed H
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Background. Neglected clubfoot in this series is defined as untreated equino-cavo-adducto-varus in older children, or adults. Relapsed clubfoot is the residual deformity that remains after single or multiple surgical interventions. Severe neglected clubfoot rarely exists today in developed countries, except in some emigrants from low- and middle-income countries. Acute surgical management with corrective mid-foot osteotomy and elongation of the Achilles tendon has excellent functional outcome. Objective. To assess the functional outcome of acute correction of neglected Talipes-quino-varus deformity in adults. Methods. This is cross sectional, hospital–based study that took place in Khartoum, Sudan. Forty patients were included in this study. Midfoot osteotomy and elongation of the Achilles tendon were performed to all patients. Data was collected using a questionnaire and the functional outcome has been assessed using the American Orthopaedic Foot and Ankle Society Score (AOFAS). This score was measured before surgery and one years after surgery. Results. The mean age was 19.9±4.7 years. Males were 25 (62.5%) and females were 15 (37.5%). The mean preoperative AOFAS score was 37.7±7.1 (poor). This score improved to 80.7±13.7 (good to excellent), two years after surgery. However, this indicates significant change in the functional outcome after the operation (P value < 0.05). Excellent post-operative functional outcome was found among patients aged 18 – 23 years 18 (50%) P. value: 0.021. The majority of patients 36(90%) were fully satisfied with the operation, 2(5%) partially satisfied and 2(5%) were unsatisfied. Conclusion. Acute correction of neglected and relapsed TEV with elongation of the Achilles tendon and single midfoot osteotomy has excellent functional outcome as assessed by AOFAS Score. The satisfaction with this procedure is impressive. The younger age population showed better outcomes with this procedure