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Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 22 - 22
1 Jan 2014
Cowan C Ahluwalia R Howard N Hennessy M Platt S
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Informed consent is integral to good-practice. It protects the patient and offers proof of discussion and interaction between the surgeon and the patient. We compare efficacy of last clinic consent, specialised consent clinic with or without provision of patient specific literature. Group A patients underwent written consent at their last outpatient clinic and conformation of consent on the morning of surgery. Group B underwent consent in designated pre-admission clinic in the week prior to surgery. Group (C) attended the same preadmission clinic and were provided with a surgeon dictated written explanation of their surgery and particular risks. This included a explanation of the procedure, complications, risks and rewards in layman's terms, aimed at patients with a reading age of 14 years, with advice concerning alternative procedures and the consequences of taking no action. The risks are graded: common, less common and rare. All patients undertook a pre-surgery questionnaire on the morning of surgery by an independent observer prior to any contact with the surgical team. Questions focused on their planed procedure, post-operative instructions and possible complications in order to assess the recall of the consent process. A VAS-scale was added to assess overall satisfaction. Statistical analysis was undertaken by a T-test. In total 162-patients were assessed, the response rate was 68.5% (n=111). In-group A (n=16) 18.8% patients remembered 3 relevant complications, 56.2% recalled their post-operative considerations their overall satisfaction was 4/10. In-group B (n=57) 45.5% remembered three complications, 63.7% recalled their postoperative considerations and had a patient satisfaction of 5/10. In-group C (n=38) 48.3% remembered three complications, and 70.7% recalled postoperative considerations, the overall satisfaction improved to 6/10. We observed that the consent process is improved by the use of routine pre-operative consent clinics; however the addition of patient specific literature is observed to further improve recall and satisfaction


Bone & Joint Open
Vol. 2, Issue 8 | Pages 631 - 637
10 Aug 2021
Realpe AX Blackstone J Griffin DR Bing AJF Karski M Milner SA Siddique M Goldberg A

Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637


Aims. Osteochondral lesions of the talus (OLT) are a common cause of disability and chronic ankle pain. Many operative treatment strategies have been introduced; however, they have their own disadvantages. Recently lesion repair using autologous cartilage chip has emerged therefore we investigated the efficacy of particulated autologous cartilage transplantation (PACT) in OLT. Methods. We retrospectively analyzed 32 consecutive symptomatic patients with OLT who underwent PACT with minimum one-year follow-up. Standard preoperative radiography and MRI were performed for all patients. Follow-up second-look arthroscopy or MRI was performed with patient consent approximately one-year postoperatively. Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score and International Cartilage Repair Society (ICRS) grades were used to evaluate the quality of the regenerated cartilage. Clinical outcomes were assessed using the pain visual analogue scale (VAS), Foot Function Index (FFI), and Foot Ankle Outcome Scale (FAOS). Results. All patients had ICRS grade IV cartilage lesions, except for one (ICRS grade III). The paired MOCART scores significantly improved from 42.5 (SD 1.53) to 63.5 (SD 22.60) (p = 0.025) in ten patients. Seven patients agreed to undergo second-look arthroscopy; 5 patients had grade I (normal) ICRS scores and two patients had grade II (nearly normal) ICRS scores. VAS, FFI, and all subscales of FAOS were significantly improved postoperatively (p ≤ 0.003). Conclusion. PACT significantly improved the clinical, radiological, and morphological outcomes of OLT. We consider this to be a safe and effective surgical method based on the short-term clinical results of this study. Cite this article: Bone Jt Open 2023;4(12):942–947


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 14 - 14
16 May 2024
Davey M Stanton P Lambert L McCarton T Walsh J
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Aims. Management of intra-articular calcaneal fractures remains a debated topic in orthopaedics, with operative fixation often held in reserve due to concerns regarding perioperative morbidity and potential complications. The purpose of this study was to identify the characteristics of patients who developed surgical complications to inform the future stratification of patients best suited to operative treatment for intra-articular calcaneal fractures and those in whom surgery was highly likely to produce an equivocal functional outcome with potential post-operative complications. Methods. All patients who underwent open reduction and internal fixation of calcaneal fractures utilizing the Sinus Tarsi approach between March 2014 and July 2018 were identified using theatre records. Patient imaging was used to assess pre- and post-operative fracture geometry with Computed Tomography (CT) used for pre-operative planning. Each patient's clinical presentation was established through retrospective analysis of medical records. Patients provided verbal consent to participation and patient reported outcome measures were recorded using the Maryland Foot Score. Results. Fifty-eight intra-articular calcaneal fractures (fifty-three patients including five bilateral, mean age = 46.91 years) were included. Forty-nine patients were injured as a result of a fall from a height (92.4%). Mean time from presentation to surgery was 3.23 days (range 0–21). Mean Maryland Foot score was found to be 77.6 (+/− 16.22) in forty-five patients. Five patients (9.4%) had wound complications; two superficial (3.7%) and three deep (5.6%). Conclusion. Intra-articular fractures of the calcaneus should be considered for surgical intervention in order to improve long-term functional outcomes. The Sinus Tarsi approach provides the potential to decrease the operative complication rate whilst maintaining adequate fixation, however, the decision to surgically manage these fractures should be carefully balanced against the risk of post-operative complications. This increased risk of complication associated with smoking may tip the balance against benefit from surgical management


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_11 | Pages 22 - 22
4 Jun 2024
Woods A Henari S Kendal A Rogers M Brown R Sharp R Loizou CL
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Background. Open or arthroscopic ankle fusion (AAF) is a successful operative treatment for end-stage ankle arthritis. Evidence suggest that AAFs have better outcomes. In addition to the operative technique other patient-factors can influence outcomes. The most significant complication of ankle fusion is a non-union. To better understand the risk factors related to this we undertook a retrospective investigation of primary AAFs. Methods. We reviewed all AAFs conducted at our institution over a 10-year period. Patients excluded if they had simultaneous fusion of neighbouring joints or were lost to follow-up. The primary outcome variable was radiographic union. Other operative complications were analysed as secondary outcomes. Two hundred and eighty-four eligible AAFs in 271 patients were performed over the study period. Results. The overall non-union rate was 7.7 %. Univariate logistic regression analysis found that smoking (6.2% non-union in non-smokers vs 24% in smokers) and prior triple fusion (5.5% non-union in the absence of prior triple fusion vs 70% in the presence of a prior triple fusion) were independent risk factors for non-union. Multivariate analysis showed that only prior triple fusion was predictive (OR 40.0 [9.4,170.3], p < 0.0001). Increasing age, obesity (BMI >30), surgical grade (trainee vs consultant), diabetes or the degree of weightbearing status post-operatively were not significant risk factors of non-union. The leading cause of reoperation was the removal of metal (18%). There were 5 superficial (1.8%) and 4 deep (1.4%) infections. Kaplan-Meier survival analysis showed a 75% ‘survivorship’ of the subtalar joint at 10 years following an arthroscopic ankle fusion. Conclusion. This is the largest case series of AAFs in the literature and the first to demonstrate that patients who had an AAF performed after a previous triple fusion have unacceptably high non-union rates and may benefit from other surgical options. This study data could also useful for patient consenting purposes


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1352 - 1358
1 Oct 2018
Clough TM Alvi F Majeed H

Aims. Total ankle arthroplasty (TAA) surgery is complex and attracts a wide variety of complications. The literature lacks consistency in reporting adverse events and complications. The aim of this article is to provide a comprehensive analysis of each of these complications from a literature review, and to compare them with rates from our Unit, to aid clinicians with the process of informed consent. Patients and Methods. A total of 278 consecutive total ankle arthroplasties (251 patients), performed by four surgeons over a six-year period in Wrightington Hospital (Wigan, United Kingdom) were prospectively reviewed. There were 143 men and 108 women with a mean age of 64 years (41 to 86). The data were recorded on each follow-up visit. Any complications either during initial hospital stay or subsequently reported on follow-ups were recorded, investigated, monitored, and treated as warranted. Literature search included the studies reporting the outcomes and complications of TAA implants. Results. There were wound-healing problems in nine ankles (3.2%), superficial infection in 20 ankles (7.2%), and deep infection in six ankles (2.2%). Intraoperative fractures occurred in medial malleoli in 27 ankles (9.7%) and in lateral malleoli in four ankles (1.4%). Aseptic loosening and osteolysis were seen 16 ankles (5.8%). Fracture of the polyethylene component occurred in one ankle (0.4%) and edge-loading in seven ankles (2.5%). We observed medial gutter pain in 31 ankles (11.1%). The incidence of thromboembolism occurred in two ankles (0.7%). The results were found to be comparable to the previously reported complications of total ankle arthroplasty in the literature. Conclusion. Total ankle arthroplasty continues to evolve and improve the ankle function. Despite high overall complication rates with TAA surgery, most complications appear to be minor and do not affect final clinical outcome. Our results and literature review will help in the consent process and provide detailed complication rates for an informed consent. Cite this article: Bone Joint J 2018;100-B:1352–8


Bone & Joint Open
Vol. 4, Issue 12 | Pages 957 - 963
18 Dec 2023
van den Heuvel S Penning D Sanders F van Veen R Sosef N van Dijkman B Schepers T

Aims

The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS).

Methods

All patients included in the ‘ROutine vs on DEmand removal Of the syndesmotic screw’ (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups.


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 895 - 904
1 Aug 2023
Smith TO Dainty J Loveday DT Toms A Goldberg AJ Watts L Pennington MW Dawson J van der Meulen J MacGregor AJ

Aims

The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures.

Methods

Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics.


Aims

Arthroscopic microfracture is a conventional form of treatment for patients with osteochondritis of the talus, involving an area of < 1.5 cm2. However, some patients have persistent pain and limitation of movement in the early postoperative period. No studies have investigated the combined treatment of microfracture and shortwave treatment in these patients. The aim of this prospective single-centre, randomized, double-blind, placebo-controlled trial was to compare the outcome in patients treated with arthroscopic microfracture combined with radial extracorporeal shockwave therapy (rESWT) and arthroscopic microfracture alone, in patients with ostechondritis of the talus.

Methods

Patients were randomly enrolled into two groups. At three weeks postoperatively, the rESWT group was given shockwave treatment, once every other day, for five treatments. In the control group the head of the device which delivered the treatment had no energy output. The two groups were evaluated before surgery and at six weeks and three, six and 12 months postoperatively. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale. Secondary outcome measures included a visual analogue scale (VAS) score for pain and the area of bone marrow oedema of the talus as identified on sagittal fat suppression sequence MRI scans.


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1093 - 1099
1 Oct 2024
Ferreira GF Lewis TL Fernandes TD Pedroso JP Arliani GG Ray R Patriarcha VA Filho MV

Aims

A local injection may be used as an early option in the treatment of Morton’s neuroma, and can be performed using various medications. The aim of this study was to compare the effects of injections of hyaluronic acid compared with corticosteroid in the treatment of this condition.

Methods

A total of 91 patients were assessed for this trial, of whom 45 were subsequently included and randomized into two groups. One patient was lost to follow-up, leaving 22 patients (24 feet) in each group. The patients in the hyaluronic acid group were treated with three ultrasound-guided injections (one per week) of hyaluronic acid (Osteonil Plus). Those in the corticosteroid group were treated with three ultrasound-guided injections (also one per week) of triamcinolone (Triancil). The patients were evaluated before treatment and at one, three, six, and 12 months after treatment. The primary outcome measure was the visual analogue scale for pain (VAS). Secondary outcome measures included the American Orthopaedic Foot and Ankle Society (AOFAS) score, and complications.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 256 - 261
1 Mar 2024
Goodall R Borsky K Harrison CJ Welck M Malhotra K Rodrigues JN

Aims

The Manchester-Oxford Foot Questionnaire (MOxFQ) is an anatomically specific patient-reported outcome measure (PROM) currently used to assess a wide variety of foot and ankle pathology. It consists of 16 items across three subscales measuring distinct but related traits: walking/standing ability, pain, and social interaction. It is the most used foot and ankle PROM in the UK. Initial MOxFQ validation involved analysis of 100 individuals undergoing hallux valgus surgery. This project aimed to establish whether an individual’s response to the MOxFQ varies with anatomical region of disease (measurement invariance), and to explore structural validity of the factor structure (subscale items) of the MOxFQ.

Methods

This was a single-centre, prospective cohort study involving 6,637 patients (mean age 52 years (SD 17.79)) presenting with a wide range of foot and ankle pathologies between January 2013 and December 2021. To assess whether the MOxFQ responses vary by anatomical region of foot and ankle disease, we performed multigroup confirmatory factor analysis. To assess the structural validity of the subscale items, exploratory and confirmatory factor analyses were performed.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 301 - 306
1 Mar 2023
Jennison T Ukoumunne O Lamb S Sharpe I Goldberg AJ

Aims

Despite the increasing numbers of ankle arthroplasties, there are limited studies on their survival and comparisons between different implants. The primary aim of this study was to determine the failure rates of primary ankle arthroplasties commonly used in the UK.

Methods

A data linkage study combined National Joint Registry (NJR) data and NHS Digital data. The primary outcome of failure was defined as the removal or exchange of any components of the implanted device. Life tables and Kaplan-Meier survival charts were used to illustrate survivorship. Cox proportional hazards regression models were fitted to compare failure rates between 1 April 2010 and 31 December 2018.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 949 - 956
1 Sep 2024
Matthews PA Scammell BE Coughlin TA Nightingale J Ollivere BJ

Aims

This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme.

Methods

A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_17 | Pages 3 - 3
1 Nov 2014
Akkena S Karim T Clough T Karski M Smith R
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Introduction:. The aim of this study was to identify the rate of complications of total ankle replacement in a single Centre to help with informed patient consent. Methods:. Between 2008 and 2012, 202 total ankle replacements (TARs) were performed by 4 surgeons at our Institute. Data was collected on all patients; demographics, arthritic disease, pre-operative deformity, prosthesis and all early and late complications. Results:. 4 surgeons (A, B, C, D) performed 63, 55, 48 and 36 TARs (178 De Puy Mobility and 24 Corin Zenith). 130 patients had primary osteoarthrosis, 35 had rheumatoid and 36 had post traumatic osteoarthrosis. There were no differences in patient demographics for each surgeon. There were 3 deep infections (A, B, C, D: 1,0,2,0). There were 18 medial malleolar fractures (8 intra-operative [4,1,1,2], 3 early (< 3 months) [1,1,0,1] and 7 late (> 3 months) [2,2,2,1]). There were 2 lateral malleolar fractures, both intra-operative (0,0,1,1). There were 15 patients who developed superficial wound infections, which resolved fully with oral antibiotics (4,3,4,4). A further 7 patients had a delay to wound healing (wound not fully healed at 3 months) (4,0,2,1); 2 of these developed deep infection and failed. 22 patients had persistent medial gutter pain (9,4,5,4); all had undergone Mobility TAR. 4 patients developed recurrent edge loading and have had to be revised (4 converted to TTC fusion) (2,0,2,0). We report complications in 32% of patients. Overall 9 TARs failed and underwent revision to fusion (2,2,5,0). Conclusion:. We report an overall complication rate of 32% following TARs, however most are minor and don't affect clinical outcome. We had a 1.5% deep infection rate. Complication rates were comparable between 4 surgeons. There was a difference in medial gutter pain rate between implants (13% v 0% Mobility to Zenith). This data provides detailed complication rates for informed consent


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 938 - 945
1 Aug 2022
Park YH Kim W Choi JW Kim HJ

Aims

Although absorbable sutures for the repair of acute Achilles tendon rupture (ATR) have been attracting attention, the rationale for their use remains insufficient. This study prospectively compared the outcomes of absorbable and nonabsorbable sutures for the repair of acute ATR.

Methods

A total of 40 patients were randomly assigned to either braided absorbable polyglactin suture or braided nonabsorbable polyethylene terephthalate suture groups. ATR was then repaired using the Krackow suture method. At three and six months after surgery, the isokinetic muscle strength of ankle plantar flexion was measured using a computer-based Cybex dynamometer. At six and 12 months after surgery, patient-reported outcomes were measured using the Achilles tendon Total Rupture Score (ATRS), visual analogue scale for pain (VAS pain), and EuroQoL five-dimension health questionnaire (EQ-5D).


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 472 - 478
1 Apr 2022
Maccario C Paoli T Romano F D’Ambrosi R Indino C Federico UG

Aims

This study reports updates the previously published two-year clinical, functional, and radiological results of a group of patients who underwent transfibular total ankle arthroplasty (TAA), with follow-up extended to a minimum of five years.

Methods

We prospectively evaluated 89 patients who underwent transfibular TAA for end-stage osteoarthritis. Patients’ clinical and radiological examinations were collected pre- and postoperatively at six months and then annually for up to five years of follow-up. Three patients were lost at the final follow-up with a total of 86 patients at the final follow-up.


Bone & Joint Open
Vol. 2, Issue 7 | Pages 503 - 508
8 Jul 2021
Callaghan CJ McKinley JC

Aims

Arthroplasty has become increasingly popular to treat end-stage ankle arthritis. Iatrogenic posterior neurovascular and tendinous injury have been described from saw cuts. However, it is hypothesized that posterior ankle structures could be damaged by inserting tibial guide pins too deeply and be a potential cause of residual hindfoot pain.

Methods

The preparation steps for ankle arthroplasty were performed using the Infinity total ankle system in five right-sided cadaveric ankles. All tibial guide pins were intentionally inserted past the posterior tibial cortex for assessment. All posterior ankles were subsequently dissected, with the primary endpoint being the presence of direct contact between the structure and pin.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 11 - 11
1 Dec 2015
Barr L Loizou C Smith G Loveday D
Full Access

Introduction. The aim of this study was to identify the effects of first MTPJ arthritis, ankle arthritis and hallux valgus on patient reported outcomes, and to assess the efficacy of surgery. Methods. Patients who underwent first MTPJ fusion, ankle fusion or hallux valgus correction from July 2013 to October 2014 were included in the study. Exclusion criteria included revision or simultaneous bilateral surgery, inflammatory arthropathy, or arthritis of a proximal joint awaiting arthroplasty. Subjects completed the Manchester-Oxford Foot Questionnaire (MOX-FQ), EQ-5D index, and EQ-5D health scale on presentation and at least six months post-operatively. Between group statistical analysis was carried out using one-way ANOVA, pre- and post-operative scores were compared using a paired t-test. Results. Eighty-two patients completed pre-operative questionnaires. Seventy-four (22 male, 52 female) of these (90%) completed post-operative questionnaires at a median of 10 months (range 6–17 months). The median age was 64 years (range 36–85 years). Pre-operative MOX-FQ and EQ-5D scores differed significantly between the groups (both p< 0.001) with ankle fusion patients reporting the worst scores and hallux valgus patients the best. Post-operative MOX-FQ and EQ-5D did not differ between groups (p=0.52, p=0.06 respectively). MOX-FQ significantly improved in all groups from pre-operatively (MTPJ p=0.0001; Ankle p=0.0002; Hallux Valgus p< 0.0001). EQ-5D only statistically improved following surgery for arthritic conditions (MTPJ p< 0.001; ankle p< 0.001; Hallux valgus p=0.06). The EQ-5D health scale did not show any differences between the groups either pre- or post-operatively, nor between pre- and post-op scores for each type of surgery. Conclusions. MOX-FQ and EQ-5D scores differ between patients with different foot and ankle pathologies. Both scores significantly improve following surgery for arthritic conditions, but only the more specific MOX-FQ improves following hallux valgus correction. These results will be of benefit when consenting patients pre-operatively, and potentially for prioritisation of healthcare provision


Bone & Joint Open
Vol. 2, Issue 3 | Pages 150 - 163
1 Mar 2021
Flett L Adamson J Barron E Brealey S Corbacho B Costa ML Gedney G Giotakis N Hewitt C Hugill-Jones J Hukins D Keding A McDaid C Mitchell A Northgraves M O'Carroll G Parker A Scantlebury A Stobbart L Torgerson D Turner E Welch C Sharma H

Aims

A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.

Methods

A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_17 | Pages 7 - 7
1 Nov 2014
Chirputkar K Bhosale A Pillai A
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Introduction:. PREMS and PROMS are part of the national initiative of the DoH. They measure quality from patient perspective and also help patient choice. We present our pioneering experience of PROMS 2.0 which is a semi automated web based system to collect and analyse outcome data in real time. Materials and methods:. Data was prospectively collected from January 2013 to June 2014. Outcome measures included EQ-5D VAS, EQ-5D Health Index, and MOxFQ, collected pre-operatively and post-operatively. Patient Personal Experience (PPE-15) was collected postoperatively. A semi-automated e mail based system – Amplitude – was used. Results:. 345 patients consented to participate.147 patients (42.6%) and 168 pathways (47%) signed up for PROMs 2.0 programme. 40 (27%) did not complete either pre-op or post op questionnaire after signing up. 30 patients (20.4%) completed pre-op and at least one post op score. 99 patients (58.9%) completed PPE questionnaire. 83% of respondents had improved or unchanged EQ-5D VAS score, and EQ-5D Health Index. MOxFQ scores showed improvement in over 80% of responses. 88% responded favourably (YES) to PPE 15 questionnaire. Conclusion:. Our data shows an improvement in PROMS and a favourable PREMS in excess of 80% of our elective foot & ankle patients following surgery. Patient response was higher for PPE questionnaire compared to other PROMs outcomes. Methods to increase patient enrolment and to encourage higher participation are required. We feel patient education and simplification of PROMS 2.0 are the key