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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 24 - 24
1 Sep 2012
Malik A Ali S Mann B Natfogel E Charalambides C
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Akins original description of his osteotomy did not describe the use of any metal work. Today the osteotomy is most commonly held and fixed with either a staple or screw. We describe the results obtained with a simple suture technique. Methods Data was collected prospectively on 125 patients undergoing an Akin osteotomy. Hallux valgus (HV) and intermetatarsal (IM) angles pre and postoperatively were recorded. Patients were reviewed at 6 week follow up. Cost analysis was also performed comparing different fixation types. 111 of the patients were female and 14 male. The average age at time of surgery was 49 years. 104 cases were in conjunction with hallux valgus correction while 21 cases were for hallux interphalangeus. The mean preoperative HV angle was 33.3 degrees (range 22 to 53), and the IM angle 13.3 degrees (range 9 to 25). At the 6 week follow up all patients had shown signs of radiological union. The postoperative HV angle was 12.4 degrees (range 7 to 17) and the IM angle 6.4 degrees (range 5 to 11). All patients maintained their correction. There were no complications, infections or fixation problems. All patients were satisfied with their surgery and would have it repeated again. The suture technique was the most cost effective method. We describe a quick, easy, implant free method of fixing the Akin osteotomy. There is no need for metalwork removal and in today's world of austerity and the current climate of widespread budget constraints we describe a cost effective method which is clinically just as effective as methods requiring a staple or screw


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 25 - 25
1 Dec 2015
Dall G Clement N McDonald D Ahmed I Duckworth A Shalaby H McKinley J
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We present a review of 97 consecutive BioPro. ®. metallic hemiarthroplasties performed in 80 patients for end-stage hallux rigidus, with a minimum of five years follow-up. The mean age of the cohort was 55 (22 to 74) years. No patient was lost to follow-up. There were 15 revisions performed, one for infection, two for osteolysis, and 12 for pain. The all cause survival rate at five years was 85.6% (95% confidence interval (CI) 83.5 to 87.9). Younger age was a significant predictor of revision (odds ratio 1.09, 95% CI 1.02 to 1.17, p=0.014) on excluding infection and adjusting for confounding variables (Cox regression). Significant improvements were demonstrated at 5 years in the Manchester Oxford foot questionnaire (13.9, 95% CI 10.5 to 17.2) and in the physical component of the short form 12 score (6.5, 95% CI 4.1 to 8.9). The overall satisfaction rate was 72%. The cost per quality-adjusted-life-year at 5 years, accounting for a 3% per year revision rate, was £3,714. The BioPro offers good short to mid-term functional outcome and is a cost effective intervention. The relative high revision rate is associated with younger age and the use of this implant may be limited to older patients


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_21 | Pages 14 - 14
1 Apr 2013
Baraza N Lever S Waight G Dhukaram V
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Introduction

Operative fixation of ankle fractures is often deferred due to swelling to avoid the risk of wound problems. The routine practice is to admit the patient and operate once the swelling has subsided. We introduced a new pathway to manage these ankle fractures at home preoperatively to improve service efficiency. We studied the impact of home therapy on length of inpatient stay and associated problems.

Methods

A control group was studied from December 2009 to March 2010, where patients were treated normally. The home therapy ankle pathway was then introduced in August 2010. Patients presenting with excess ankle swelling were placed in a back slab following reduction of ankle to a satisfactory position. The patients were provided limb care advice, thromboprophylaxis, an emergency contact number and discharged home on crutches with a predetermined operative slot, usually 6 days following injury. Patients were also contacted by a member of staff to ensure they were coping with the injured limb at home. Patients who are unsafe to be discharged on home therapy were admitted. This cohort of patients was studied between August 2010 and December 2011.


Bone & Joint Open
Vol. 3, Issue 6 | Pages 455 - 462
6 Jun 2022
Nwankwo H Mason J Costa ML Parsons N Redmond A Parsons H Haque A Kearney RS

Aims. To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture. Methods. A within-trial economic evaluation conducted from the UK NHS and personnel social services (PSS) perspective. Health resources and quality-of-life data were collected as part of the Ankle Injury Rehabilitation (AIR) multicentre, randomized controlled trial over a 12-month period using trial case report forms and patient-completed questionnaires. Cost-utility analysis was estimated in terms of the incremental cost per quality adjusted life year (QALY) gained. Estimate uncertainty was explored by bootstrapping, visualized on the incremental cost-effectiveness ratio plane. Net monetary benefit and probability of cost-effectiveness were evaluated at a range of willingness-to-pay thresholds and visualized graphically. Results. The incremental cost and QALYs of using brace over a 12-month period were £46.73 (95% confidence interval (CI) £-9 to £147) and 0.0141 (95% CI -0.005 to 0.033), respectively. The cost per QALY gained was £3,318. The probability of brace being cost-effective at a £30,000 per QALY willingness-to-pay threshold was 88%. The results remained robust to a range of sensitivity analyses. Conclusion. This within-trial economic evaluation found that it is probable that using a removable brace provides good value to the NHS when compared to cast, in the management of adults with ankle fracture. Cite this article: Bone Jt Open 2022;3(6):455–462


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 2 - 2
17 Jun 2024
Fishley W Morrison R Baldock T Hilley A Baker P Townshend D
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Background. In fixation of the fibula in ankle fractures, AO advocate using a lag screw and one-third tubular neutralisation plate for simple patterns. Where a lag screw cannot be placed, bridging fixation is required. A local pilot service evaluation previously identified variance in use of locking plates in all patterns with significant cost implications. The FAIR study aimed to evaluate current practice and implant use across the United Kingdom (UK) and review outcomes and complication rates between different fibula fixation methods. Method. The study was supported by CORNET, the North East trainee research collaborative, and BOTA. Data was collected using REDCap from 22 centres in the UK retrospectively for a one-year period between 1. st. January 2019 and 31. st. December 2019 on injury mechanism, fracture characteristics, comorbidities, fixation and complications. Follow-up data was collected to at least two-years from the time surgery. Results. 1448 ankle fractures which involved fixation of the fibula were recorded; one-third tubular plate was used in 866 (59.8%) cases, a locking plate in 463 (32.0%) cases and other methods in 119 (8.2%) cases. There was significant difference between centres (p<0.001) in implant type used. Other factors associated with implant type were age, diabetes, osteoporosis, open fractures, fracture pattern and the presence of comminution. Incidence of lateral wound breakdown was higher in locking plates than one-third tubular plates (p<0.05). There was no significant difference in infection, non-union, fixation failure or removal of metalware. Conclusion. There is significant variation in practice in the UK in implant use for fixation of the fibula in ankle fractures. Potentially unnecessary use of locking plates, where a one-third tubular shows equivalent outcomes, incurs additional cost and may increase the risk of lateral wound breakdown. We would encourage surgeons with high locking plate usage to evaluate their own unit's practice against this data


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 9 - 9
16 May 2024
Galhoum A Abd-Ella M ElGebeily M Rahman AA Zahlawy HE Ramadan A Valderrbano V
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Background. Charcot neuroarthropathy is a destructive disease characterized by progressive bony fragmentation as a result of the isolated or accumulative trauma in patients with decreased sensation that manifests as dislocation, periarticular fractures and instability. Although amputation can be a reasonable cost economic solution, many patients are willing to avoid that if possible. We explored here one of the salvage procedures. Methods. 23 patients with infected ulcerated unstable Charcot neuroarthropathy of the ankle were treated between 2012 and 2017. The mean age was 63.5 ±7.9 years; 16 males and 7 females. Aggressive open debridement of ulcers and joint surfaces, with talectomy in some cases, were performed followed by external fixation with an Ilizarov frame. The primary outcome was a stable plantigrade infection free foot and ankle that allows weight bearing in accommodative foot wear. Results. Limb salvage was achieved in 91.3% of cases at the end of a mean follow up time of 25 months (range: 19–32). Fifteen (71.4%) solid bony unions were evident clinically and radiographically, while 6 (28.5%) patients developed stable painless pseudoarthrosis. Two patients had below knee amputations due to uncontrolled infection. Conclusion. Aggressive debridement and arthrodesis with ring external fixation can be used successfully to salvage severely infected Charcot arthropathy of the ankle. Pin tract infection, delayed wound healing and stress fracture may complicate the procedure but can be easily managed. Amputation may be the last resort in uncontrolled infection


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 11 - 11
17 Jun 2024
Lewis T Ferreira G Nunes G Ray R
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Background. Infiltration is considered the first treatment option for symptomatic Morton's neuroma and can be performed with various medications. The aim of this study was to compare the effects of hyaluronic acid infiltration versus corticosteroid injection in the treatment of Morton's neuroma. Methods. A randomised clinical trial was conducted with 46 patients (50 feet) diagnosed with Morton's neuroma. After randomisation, the control group (CG) received three injections (one per week) of triamcinolone (Triancil®) guided by ultrasound, while the study group (SG) received three applications of hyaluronic acid (Osteonil Plus®). Patients were followed up for six months after the intervention. The primary outcome measure used was the Visual Pain Analog Scale (VAS). Secondary endpoints included patient-reported outcome measures using the American Orthopaedic Foot & Ankle Society (AOFAS) score and complications. Results. Both groups showed significant improvement in VAS and AOFAS scores (p < 0.001). The CG showed greater improvement than the SG in the VAS (p < 0.05) and AOFAS (p < 0.001) variables. Four patients in the CG experienced skin hypochromia at the injection site, while there were no complications in the SG. Conclusion. Ultrasound-guided hyaluronic acid infiltration in Morton's Neuroma proved to be safe, showing improvement in pain and function after six months of follow-up, without major complications, but with a significantly lower improvement when compared to corticosteroid injection. Taking into account cost implications and the potential for longer lasting improvement from viscosupplementation further medium- and long-term studies are needed


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 18 - 18
17 Jun 2024
Andres L Donners R Harder D Krähenbühl N
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Background. Weightbearing computed tomography scans allow for better understanding of foot alignment in patients with Progressive Collapsing Foot Deformity. However, soft tissue integrity cannot be assessed via WBCT. As performing both WBCT and magnetic resonance imaging is not cost effective, we aimed to assess whether there is an association between specific WBCT and MRI findings. Methods. A cohort of 24 patients of various stages of PCFD (mean age 51±18 years) underwent WBCT scans and MRI. In addition to signs of sinus tarsi impingement, four three-dimensional measurements (talo-calcaneal overlap, talo-navicular coverage, Meary's angle axial/lateral) were obtained using a post processing software (DISIOR 2.1, Finland) on the WBCT datasets. Sinus tarsi obliteration, spring ligament complex and tibiospring ligament integrity, as well as tibialis posterior tendon degeneration were evaluated with MRI. Statistical analysis was performed for significant (P<0.05) correlation between findings. Results. None of the assessed 3D measurements correlated with spring ligament complex or tibiospring ligament tears. Age, body mass index, and TCO were associated with tibialis posterior tendon tears. 75% of patients with sinus tarsi impingement on WBCT also showed signs of sinus tarsi obliteration on MRI. Of the assessed parameters, only age and BMI were associated with sinus tarsi obliteration diagnosed on MRI, while the assessed WBCT based 3D measurements were, with the exception of MA axial, associated with sinus tarsi impingement. Conclusion. While WBCT reflects foot alignment and indicates signs of osseous impingement in PCFD patients, the association between WBCT based 3D measurements and ligament or tendon tears in MRI is limited. Partial or complete tears of the tibialis posterior tendon were only detectable in comparably older and overweight PCFD patients with an increased TCO. WBCT does not replace MRI in diagnostic value. Both imaging options add important information and may impact decision-making in the treatment of PCFD patients


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 945 - 951
1 Jul 2016
Clement ND MacDonald D Dall GF Ahmed I Duckworth AD Shalaby HS McKinley J

Aims. To examine the mid-term outcome and cost utility of the BioPro metallic hemiarthroplasty for the treatment of hallux rigidius. Patients and Methods. We reviewed 97 consecutive BioPro metallic hemiarthroplasties performed in 80 patients for end-stage hallux rigidus, with a minimum follow-up of five years. There were 19 men and 61 women; their mean age was 55 years (22 to 74). No patient was lost to follow-up. Results. A total of 12 patients (15 first metatarso-phalangeal joints (MTPJs)) required a revision; one for infection, two for osteolysis and 12 for pain. The all cause rate of survival at five years was 85.6% (95% confidence interval (CI) 83.5 to 87.9). Younger age was a significant predictor of revision (odds ratio 1.09, 95% CI 1.02 to 1.17, p = 0.014) on excluding infection and adjusting for confounding variables (Cox regression). Significant improvements were demonstrated at five years in the Manchester Oxford Foot Questionnaire (13.9, 95% CI 10.5 to 17.2) and in the physical component of the Short Form-12 score (6.5, 95% CI 4.1 to 8.9). The overall rate of satisfaction was 75%. The cost per quality adjusted life year at five years, accounting for a 14% rate of revision was between £4431 and £6361 depending on the complexity and morbidity of the patient. Conclusion. The BioPro hemiarthroplasty offers good short to mid-term functional outcome and is a cost effective intervention. The relatively high revision rate is associated with younger age and perhaps the use of this implant should be limited to older patients. Cite this article: Bone Joint J 2016;98-B:945–51


Bone & Joint Open
Vol. 3, Issue 8 | Pages 618 - 622
1 Aug 2022
Robinson AHN Garg P Kirmani S Allen P

Aims

Diabetic foot care is a significant burden on the NHS in England. We have conducted a nationwide survey to determine the current participation of orthopaedic surgeons in diabetic foot care in England.

Methods

A questionnaire was sent to all 136 NHS trusts audited in the 2018 National Diabetic Foot Audit (NDFA). The questionnaire asked about the structure of diabetic foot care services.


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).


Bone & Joint Open
Vol. 3, Issue 6 | Pages 502 - 509
20 Jun 2022
James HK Griffin J Pattison GTR

Aims

To identify a core outcome set of postoperative radiographic measurements to assess technical skill in ankle fracture open reduction internal fixation (ORIF), and to validate these against Van der Vleuten’s criteria for effective assessment.

Methods

An e-Delphi exercise was undertaken at a major trauma centre (n = 39) to identify relevant parameters. Feasibility was tested by two authors. Reliability and validity was tested using postoperative radiographs of ankle fracture operations performed by trainees enrolled in an educational trial (IRCTN 20431944). To determine construct validity, trainees were divided into novice (performed < ten cases at baseline) and intermediate groups (performed ≥ ten cases at baseline). To assess concurrent validity, the procedure-based assessment (PBA) was considered the gold standard. The inter-rater and intrarater reliability was tested using a randomly selected subset of 25 cases.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims

The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture.

Methods

This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.


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. 97-B, Issue 4 | Pages 510 - 515
1 Apr 2015
Hutchison AM Topliss C Beard D Evans RM Williams P

The Swansea Morriston Achilles Rupture Treatment (SMART) programme was introduced in 2008. This paper summarises the outcome of this programme. Patients with a rupture of the Achilles tendon treated in our unit follow a comprehensive management protocol that includes a dedicated Achilles clinic, ultrasound examination, the use of functional orthoses, early weight-bearing, an accelerated exercise regime and guidelines for return to work and sport. The choice of conservative or surgical treatment was based on ultrasound findings. . The rate of re-rupture, the outcome using the Achilles Tendon Total Rupture Score (ATRS) and the Achilles Tendon Repair Score, (AS), and the complications were recorded. An elementary cost analysis was also performed. . Between 2008 and 2014 a total of 273 patients presented with an acute rupture 211 of whom were managed conservatively and 62 had surgical repair. There were three re-ruptures (1.1%). There were 215 men and 58 women with a mean age of 46.5 years (20 to 86). Functional outcome was satisfactory. Mean ATRS and AS at four months was 53.0 (. sd . 14), 64.9 (. sd. 15) (n = 135), six months 67.8 (. sd. 16), 73.8 (. sd. 15) (n = 103) and nine months (72.4; . sd. 14) 72.3 (. sd. 13) (n = 43). The programme realised estimated cost savings exceeding £91 000 per annum. The SMART programme resulted in a low rate of re-rupture, a satisfactory outcome, a reduced rate of surgical intervention and a reduction in healthcare costs. Cite this article: Bone Joint J 2015; 97-B:510–15


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 23 - 23
1 Jan 2014
Hutchinson A Beard D Evans R Topliss C Williams P
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Introduction:. Historically the incidence of Achilles re-ruptures has been described as around 5% after surgical repair and up to 21% after conservative management. In 2008 we commenced a dedicated Achilles tendon rupture clinic for both conservative and surgically managed patients using new standardised operating procedures (SOP). We have evaluated the impact of this new service, particularly with regard to re-rupture rate. Materials and methods:. The SOP was stage dependent and included an initial ultrasound examination, functional orthotics with early weight bearing, accelerated exercise and guidelines for the return to work and sport. Evaluation included re-rupture rate, complication rate, and outcome measured by the Achilles Tendon Total Rupture Score (ATRS) and Achilles Tendon Repair Score (AS). A basic cost evaluation was performed to assess any potential savings. Results:. A total of 213 patients (151 treated conservatively and 62 surgically) were included. Re-rupture occurred in two patients (1 conservative and 1 surgically managed). There were 16 major complications e.g. DVT, wound infection. The mean ATRS was 54.79, 67.66 and 71.05 at 4, 6 and 9 months respectively and the mean AS was 64.67, 73.96 and 71.05 at 4, 6 and 9 months respectively. The reduction in re-rupture compared to the literature was 4.1% and 19.1% for surgical and conservatively treated patients respectively. Cost savings achieved were £50,000 each annum. This was due to both a decrease in the number of re-ruptures as well as a decrease in the number of patients being managed operatively. Conclusion:. A dedicated follow up Achilles clinic treating acute Achilles tendon ruptures using monitored SOP's, provides an exceptionally low re-rupture rate (0.9%), excellent patient outcome and potential cost savings compared to a traditional fracture clinic approach. The reduction in re-rupture rate, and therefore cost savings, is greater in conservatively managed patients


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1497 - 1504
1 Nov 2016
Dingemans SA Rammelt S White TO Goslings JC Schepers T

Aims. In approximately 20% of patients with ankle fractures, there is an concomitant injury to the syndesmosis which requires stabilisation, usually with one or more syndesmotic screws. The aim of this review is to evaluate whether removal of the syndesmotic screw is required in order for the patient to obtain optimal functional recovery. Materials and Methods. A literature search was conducted in Medline, Embase and the Cochrane Library for articles in which the syndesmotic screw was retained. Articles describing both removal and retaining of syndesmotic screws were included. Excluded were biomechanical studies, studies not providing patient related outcome measures, case reports, studies on skeletally immature patients and reviews. No restrictions regarding year of publication and language were applied. Results. A total of 329 studies were identified, of which nine were of interest, and another two articles were added after screening the references. In all, two randomised controlled trials (RCT) and nine case-control series were found. The two RCTs found no difference in functional outcome between routine removal and retaining the syndesmotic screw. All but one of the case-control series found equal or better outcomes when the syndesmotic screw was retained. However, all included studies had substantial methodological flaws. Conclusions. The currently available literature does not support routine elective removal of syndesmotic screws. However, the literature is of insufficient quality to be able to draw definitive conclusions. Secondary procedures incur a provider and institutional cost and expose the patient to the risk of complications. Therefore, in the absence of high quality evidence there appears to be little justification for routine removal of syndesmotic screws. Cite this article: Bone Joint J 2016;98-B:1497–1504


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 2 - 2
1 Dec 2015
Miller R
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Introduction. Diabetes is increasing on a global scale. By 2030, 10% of the global population, ½ billon people, are predicted to have diabetes. Potentially there will be a corresponding increase in number of patients referred for surgery. Traditional surgical management of these patients is challenging. Presented is a case series utilizing Minimally Invasive Surgical Techniques of percutaneous metatarsal neck osteotomies, metatarsal head debridement, mid-foot closing-wedge osteotomies and hind-foot arthrodesis, for the surgical management of diabetic foot pathology. The potential socio-economic benefits analysis with regards to reduction in out-patient and theatre time, patient length of stay and time to healing are also postulated. Methods. Minimally Invasive Surgical Techniques of metatarsal neck osteotomy, metatarsal head debridement, closing wedge osteotomy, mid-fusion and hind-foot arthrodesis nailing are described. Procedures are preformed as day cases with fluoroscopic guidance. Low speed, high torque burrs and wedges, create the osteotomies, which can be held with percutaneous fixation. Comparative cost analysis of conservative treatment, including clinic visits, out-patient debridement, dressings, intravenous and oral antibiotics, versus Minimally Invasive Surgical Techniques is presented. Results. Six patients had metatarsal osteotomies for mechanical ulceration. Five reported good outcome. One patient required revision to forefoot arthroplasty due to mal-union. Five patients had debridement of metatarsal heads, which healed on average at six to eight weeks. Eight patients had mid-foot arthrodesis. Two infected cases required removal of metalwork. Three patients had hind-foot arthrodesis for arthritis following ankle fracture with degeneration and deformity. Patients had good short and early medium term outcomes, with no reports of below-knee amputation. This technique is reproducible once the initial learning curve is mastered. Comparative cost analysis, suggests significant financial savings by reducing inpatient admissions, clinic visits and theatre time. Conclusion. Minimally Invasive Surgical Techniques may provide an alternative surgical management for diabetic patient with foot and ankle pathology


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.


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.