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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


Bone & Joint Open
Vol. 4, Issue 3 | Pages 188 - 197
15 Mar 2023
Pearson NA Tutton E Gwilym SE Joeris A Grant R Keene DJ Haywood KL

Aims

To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery.

Methods

We undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes.


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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 71 - 71
1 May 2012
Molvik H Smitham P Cullen N Singh D Goldberg A
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Introduction. Following recommendations in the NHS Plan, all Trusts in the UK now send copies of correspondence to patients as standard practice. It is not clear whether patients wish to receive such correspondence, nor whether this practices an additional workload on the NHS as patients seek clarification on the medical terminology used in their letters. Methods. We surveyed 90 consecutive patients in three Consultant Foot & Ankle surgeons' new outpatient clinics at our institution. Sixty patients received a copy of the letter sent to their GP (standard practice) and 30 patients received a letter in plain English addressed to the patient and a copy was sent to the GP (new practice). Patients were sent a cover letter explaining the study a copy of their clinic note and also a questionnaire that asked details about their preferred methods of communication. In addition qualitative interviews with 4 GP Partners were carried out to harbour their opinions. Results. 72 (80%) patients responded to the questionnaire. The majority (95%) wanted a letter about their care, but 76% preferred a letter in plain English addressed to them (new practice) rather than a copy of the letter sent to their GP (standard practice). 27% of respondents who received a copy of their GP letter stated that there were one or more words that they did not understand compared to 8.3% of respondents who received letters in simple English. Many of the patients seeking clarification identified barriers in obtaining explanation. GP's interviewed welcomed the concept of writing directly to patients and felt that this process could lead to improvements to patient care. Conclusion. The practice of copying GP letters to patients is flawed, and is not consistent with what patients' want. Central NHS dictums should receive the same level of evidenced-based scrutiny applied to clinical pathways


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 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. 94-B, Issue SUPP_XXII | Pages 79 - 79
1 May 2012
Goss M Sott A
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Background. There is a general assumption amongst many patients – and some Surgeons- that 1. Metatarsophalangeal Joint Arthrodesis “in neutral plantigrade position” will postoperatively restrict the choice of shoes and heels in particular. To our knowledge no studies have been carried out to assess this further. Methods. A review of a single Surgeon's series of 25 patients and Radiographs following neutral 1.MTPJ Arthrodesis after 14 – 38 months follow up to assess the type of shoe and height of heel comfortably worn. Results. Out of 18 women whose 1. MTPJ was fused in neutral 12 were able to wear at least a 2 inch (5 cm) heel comfortably the remaining 6 wore mainly flat shoes because of contralateral disease or unrelated reasons. All men interviewed wore a wide range of different comfortable shoes. Conclusion. 1. MTPJ Arthrodesis in neutral does not restrict the choice of shoes/heels postoperatively. Our findings might further strengthen the argument in favour of Arthrodesis vs Joint replacement


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 48 - 48
1 Sep 2012
Thompson R McKeown R
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This is a case series report on the outcomes of patients that have received ORIF of their calcaneal fractures at Craigavon Hospital, Northern Ireland, for the first 2 years since it opened. It is a one surgeon series. Methods. Patients were identified from the theatre logbook. The patient recalled to clinic for interview and examination. Outcome was assessed using The Ankle-Hindfoot Scale devised by the American Orthopaedic Foot and Ankle Society. This was recorded with data for the patient's notes and CT scans. These data included age, date of surgery, mechanism of injury, associated injuries and previous function. The calcaneal fractures were classified according to the Sanders Classification. Results. Sixteen patients identified from the theatre register. Of these patients, 10 patients were contactable and attended for evaluation. The data from these 10 patients was then analysed. There 9 male patients and one female. Time from operation from 9.5 months to 33 months. All patients had fractures classified as Sanders Type IV. All implants were Variax calcaneal plates. One patient had metalwork removed at 15 months. All patients had commenced weightbearing at 3 months. Outcome scores ranged from 52–97 (mean 78.3, median 79). Six of the ten had returned to work at this review. Subtalar motion was universally affected. Discussion. This one surgeon case series reflects the current literature on calcaneal fractures, in that there is a variation in outcome which is multifactorial. There is also a difficulty in defining a classification system which can reflect outcome. The results of this series suggest that there is a trend of improving outcome scores as time from injury progresses, and that outcome score tends to decrease as age at injury increases


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 78 - 78
1 May 2012
Smitham P Molvik H Smith K Attard J Cullen N Singh D Goldberg A
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Introduction. There are approximately 1.2 million patients using orthotics in the UK costing the NHS in excess of £100 million per annum. Despite this, there is little data available to determine efficacy and patient compliance. There have been a few reports on patient satisfaction, which indicate that between 13-50% of patients are dissatisfied with their orthotics. Our aim was to evaluate patient reported satisfaction with orthotics prescribed and to investigate the reasons behind patient dissatisfaction. Methods. Seventy consecutive patients receiving foot orthoses at the Royal National Orthopaedic Hospital were retrospectively asked to complete a questionnaire and to bring their shoes and orthotics to research clinic. The inside width of the shoes and corresponding width of the orthotic were measured. A semi-structured interview was carried out on 10 patients, including those that were satisfied or unsatisfied, using qualitative research methods to identify issues that are important to patients. Results. Forty out of 70 patients (57%) completed the questionnaire either by telephone or in the clinic. There was a statistically significant difference between the width of the orthotics and the inside diameter of the shoes that the orthotic was meant to fit in. Dissatisfaction with the new custom made insoles was reported in 28% of patients. Half of these patients reported that the insoles did not fit with their feet into their shoes, and 30% indicated a preference for cosmetic issues over function. The majority of patients had tried numerous homemade or off the shelf versions prior to attending the orthotic department. Conclusion. There is a high level of patient dissatisfaction with orthotics. This dissatisfaction was due to a disconnection between prescribed foot orthoses and shoes purchased by patients. There is an urgent need to join up these two industries to prevent financial waste and improve the cost-effectiveness of orthotic services


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 17 - 17
1 Sep 2012
Chadwick C Saxby T
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Introduction. Flexor digitorum longus (FDL) transfer and medial displacement calcaneal osteotomy (CO) is a well-recognised surgical treatment for stage II posterior tibial tendon dysfunction (PTTD). Whilst excellent results are quoted for short and medium term follow-up, the long-term outcome of this procedure is unknown. Materials and Methods. We reviewed the clinical outcome of patients with a symptomatic flexible flatfoot deformity undergoing this procedure at a mean follow up of 15.3 +/−0.7 years (range 14.4–16.5). We identified 48 patients who underwent surgery by the senior author between 1994 and 1996. We were able to contact 30 patients of whom 20 were available for clinical review. 10 patients participated via telephone interview, and also completed postal questionnaires. Results. All scores improved significantly from preoperative to latest follow-up. The mean AOFAS score improved from 48.4 presurgery to 90.0+/−13.6 (range 54–100) postsurgery. The pain component improved from a mean of 12.3 to 35.0+/−8.1 (range 20–40). Function score improved from 35.8 to 45.5+/−6.1 (range 30–50). Visual analogue score improved from 7.3 to 1.3+/−2.2 (range 0–6). Seven patients had only fair objective alignment, however six of those were totally satisfied and one satisfied with minor reservations, and all said they would have the surgery again. The mean SF36 physical component score was 39.8+/−8.4 and this showed significant correlation with the AOFAS score (r = 0.61, p = 0.009). Five patients developed further pain unresponsive to analgesia and orthotics and underwent further surgery in the form of calcaneocubuoid fusion, talonavicular fusion or triple fusion at a mean of 5.5+/−4.7 years (range 0.7–11.8) following initial surgery. 25(83%) patients were pain free and functioning well at an average of 15.3 years following surgery. Conclusion. We believe that FDL transfer and CO provides long-term pain relief and satisfactory function in the treatment of Stage II PTTD


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 662 - 667
1 May 2015
Mani SB Do H Vulcano E Hogan MV Lyman S Deland JT Ellis SJ

The foot and ankle outcome score (FAOS) has been evaluated for many conditions of the foot and ankle. We evaluated its construct validity in 136 patients with osteoarthritis of the ankle, its content validity in 37 patients and its responsiveness in 39. Data were collected prospectively from the registry of patients at our institution.

All FAOS subscales were rated relevant by patients. The Pain, Activities of Daily Living, and Quality of Life subscales showed good correlation with the Physical Component score of the Short-Form-12v2. All subscales except Symptoms were responsive to change after surgery.

We concluded that the FAOS is a weak instrument for evaluating osteoarthritis of the ankle. However, some of the FAOS subscales have relative strengths that allow for its limited use while we continue to seek other satisfactory outcome instruments.

Cite this article: Bone Joint J 2015; 97-B:662–7.


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 346 - 352
1 Mar 2015
Chadwick C Whitehouse SL Saxby TS

Flexor digitorum longus transfer and medial displacement calcaneal osteotomy is a well-recognised form of treatment for stage II posterior tibial tendon dysfunction. Although excellent short- and medium-term results have been reported, the long-term outcome is unknown. We reviewed the clinical outcome of 31 patients with a symptomatic flexible flat-foot deformity who underwent this procedure between 1994 and 1996. There were 21 women and ten men with a mean age of 54.3 years (42 to 70). The mean follow-up was 15.2 years (11.4 to 16.5). All scores improved significantly (p < 0.001). The mean American Orthopedic Foot and Ankle Society (AOFAS) score improved from 48.4 pre-operatively to 90.3 (54 to 100) at the final follow-up. The mean pain component improved from 12.3 to 35.2 (20 to 40). The mean function score improved from 35.2 to 45.6 (30 to 50). The mean visual analogue score for pain improved from 7.3 to 1.3 (0 to 6). The mean Short Form-36 physical component score was 40.6 (sd 8.9), and this showed a significant correlation with the mean AOFAS score (r = 0.68, p = 0.005). A total of 27 patients (87%) were pain free and functioning well at the final follow-up. We believe that flexor digitorum longus transfer and calcaneal osteotomy provides long-term pain relief and satisfactory function in the treatment of stage II posterior tibial tendon dysfunction.

Cite this article: Bone Joint J 2015;97-B:346–52.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 2 | Pages 215 - 221
1 Feb 2012
Dawson J Boller I Doll H Lavis G Sharp R Cooke P Jenkinson C

The responsiveness of the Manchester–Oxford Foot Questionnaire (MOXFQ) was compared with foot/ankle-specific and generic outcome measures used to assess all surgery of the foot and ankle. We recruited 671 consecutive adult patients awaiting foot or ankle surgery, of whom 427 (63.6%) were female, with a mean age of 52.8 years (18 to 89). They independently completed the MOXFQ, Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS) scores corresponding to four foot/ankle regions. A transition item measured perceived changes in foot/ankle problems post-surgery. Of 628 eligible patients proceeding to surgery, 491 (78%) completed questionnaires and 262 (42%) received clinical assessments both pre- and post-operatively. The regions receiving surgery were: multiple/whole foot in eight (1.3%), ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in 196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (> 0.8) than any SF-36 domains, suggesting superior responsiveness. In analyses that anchored change in scores and effect sizes to patients’ responses to a transition item about their foot/ankle problems, the MOXFQ performed well. The SF-36 and EQ-5D performed poorly. Similar analyses, conducted within foot-region based sub-groups of patients, found that the responsiveness of the MOXFQ was good compared with the AOFAS.

This evidence supports the MOXFQ’s suitability for assessing all foot and ankle surgery.


The Bone & Joint Journal
Vol. 95-B, Issue 12 | Pages 1650 - 1655
1 Dec 2013
van Bergen CJA van Eekeren ICM Reilingh ML Sierevelt IN van Dijk CN

We have evaluated the clinical effectiveness of a metal resurfacing inlay implant for osteochondral defects of the medial talar dome after failed previous surgical treatment. We prospectively studied 20 consecutive patients with a mean age of 38 years (20 to 60), for a mean of three years (2 to 5) post-surgery. There was statistically significant reduction of pain in each of four situations (i.e., rest, walking, stair climbing and running; p ≤ 0.01). The median American Orthopaedic Foot and Ankle Society ankle-hindfoot score improved from 62 (interquartile range (IQR) 46 to 72) pre-operatively to 87 (IQR 75 to 95) at final follow-up (p < 0.001). The Foot and Ankle Outcome Score improved on all subscales (p ≤ 0.03). The mean Short-Form 36 physical component scale improved from 36 (23 to 50) pre-operatively to 45 (29 to 55) at final follow-up (p = 0.001); the mental component scale did not change significantly. On radiographs, progressive degenerative changes of the opposing tibial plafond were observed in two patients. One patient required additional surgery for the osteochondral defect. This study shows that a metal implant is a promising treatment for osteochondral defects of the medial talar dome after failed previous surgery.

Cite this article: Bone Joint J 2013;95-B:1650–5.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 61 - 65
1 Jan 2010
Morgan SS Brooke B Harris NJ

We present the outcomes in 38 consecutive patients who had total ankle replacement using the Ankle Evolution System with a minimum follow-up of four years. Pain and function were assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) score and regular standardised anteroposterior and lateral weight-bearing radiographs were obtained. Patient satisfaction and complications were recorded and the survival of the implants was demonstrated by the Kaplan-Meier method.

The mean follow-up was for 57.8 months (48 to 80). The cumulative survival rate at six years was 94.7% (95% confidence interval 80.3 to 98.7). The mean total AOFAS score was 88.1 (53 to 100). The mean score for pain was 35.8 (20 to 40). Ten patients presented with edge-loading of whom nine had corrective surgery. Two ankles were revised, one to an arthrodesis and the other to replace the tibial component. Nine patients showed radiological evidence of osteolysis. They had minimal non-progressive symptoms and further surgery was not undertaken. Nevertheless, the concerns about osteolysis led to the implant being withdrawn by the manufacturer.

The medium-term results of the ankle evolution system ankle replacement are satisfactory with high patient satisfaction, but the rate of osteolysis is of some concern. The long-term benefit of this procedure has yet to be determined.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 8 | Pages 1071 - 1078
1 Aug 2011
Keating JF Will EM

A total of 80 patients with an acute rupture of tendo Achillis were randomised to operative repair using an open technique (39 patients) or non-operative treatment in a cast (41 patients). Patients were followed up for one year. Outcome measures included clinical complications, range of movement of the ankle, the Short Musculoskeletal Function Assessment (SMFA), and muscle function dynamometry evaluating dorsiflexion and plantar flexion of the ankle. The primary outcome measure was muscle dynamometry.

Re-rupture occurred in two of 37 patients (5%) in the operative group and four of 39 (10%) in the non-operative group, which was not statistically significant (p = 0.68). There was a slightly greater range of plantar flexion and dorsiflexion of the ankle in the operative group at three months which was not statistically significant, but at four and six months the range of dorsiflexion was better in the non-operative group, although this did not reach statistically significance either. After 12 weeks the peak torque difference of plantar flexion compared with the normal side was less in the operative than the non-operative group (47% vs 61%, respectively, p < 0.005). The difference declined to 26% and 30% at 26 weeks and 20% and 25% at 52 weeks, respectively. The difference in dorsiflexion peak torque from the normal side was less than 10% by 26 weeks in both groups, with no significant differences. The mean SMFA scores were significantly better in the operative group than the non-operative group at three months (15 vs 20, respectively, p < 0.03). No significant differences were observed after this, and at one year the scores were similar in both groups.

We were unable to show a convincing functional benefit from surgery for patients with an acute rupture of the tendo Achillis compared with conservative treatment in plaster.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 4 | Pages 494 - 498
1 Apr 2009
Cho NH Kim S Kwon D Kim HA

There are few data available regarding the association between hallux valgus and pain or functional limitation. We determined the prevalence of hallux valgus in a rural Korean population aged between 40 and 69 years, and its association with pain and function. A total of 563 subjects was examined using the foot health status questionnaire, the Short Form-36 questionnaire and weight-bearing anteroposterior radiographs.

Hallux valgus was present in 364 subjects (64.7%). It did not significantly correlate with age and was more common in women. Of the 364 subjects, 48 (13.2%) had moderate or greater deformity, defined as a hallux valgus angle > 25°. This was significantly associated with pain, worse function and worse foot health. The putative risk factors associated with painful hallux valgus were female gender, low educational attainment and the presence of pain in the knee.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 5 | Pages 605 - 609
1 May 2008
Wood PLR Prem H Sutton C

We describe the medium-term results of a prospective study of 200 total ankle replacements at a single-centre using the Scandinavian Total Ankle Replacement. A total of 24 ankles (12%) have been revised, 20 by fusion and four by further replacement and 27 patients (33 ankles) have died. All the surviving patients were seen at a minimum of five years after operation. The five-year survival was 93.3% (95% confidence interval (CI) 89.8 to 96.8) and the ten-year survival 80.3% (95% CI 71.0 to 89.6).

Anterior subluxation of the talus, often seen on the lateral radiograph in osteoarthritic ankles, was corrected and, in most instances, the anatomical alignment was restored by total ankle replacement. The orientation of the tibial component, as seen on the lateral radiograph, also affects the position of the talus and if not correct can hold the talus in an abnormal anterior position. Subtalar arthritis may continue to progress after total ankle replacement. Our results are similar to those published previously.