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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 14 - 14
17 Jun 2024
Johnson-Lynn S Curran M Allen C Webber K Maes M Enoch D Robinson A Coll A
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Introduction. Diabetic foot disease is a major public health problem with an annual NHS expenditure in excess of £1 billion. Infection increases risk of major amputation fivefold. Due to the polymicrobial nature of diabetic foot infections, it is often difficult to isolate the correct organism with conventional culture techniques, to deliver appropriate narrow spectrum antibiotics. Rapid DNA-based technology using multi-channel arrays presents a quicker alternative and has previously been used effectively in intensive care and respiratory medicine. Methods. We gained institutional and Local Ethics Committee approval for a prospective cohort study of patients with clinically infected diabetic foot wounds. They all had deep tissue samples taken in clinic processed with conventional culture and real-time PCR TaqMan array. Results. 50 samples were taken from 39 patients between October 2020 and March 2022. 84% of patient were male, 88% had type 2 diabetes. The ulcers were of variable chronicity prior to sampling (range 1–113 weeks) and mean HbA1c was 67.2mmol/mol. Ulcers were on the heel (3), midfoot (6) and forefoot (41). Minimum follow up was 3 months. 6 ulcers healed, 24 patients were admitted due to foot disease, there were 2 major amputations and 4 deaths. TaqMan array results were available a mean of 4.3 days earlier than culture results. 9 patients had negative conventional cultures and 8 were negative onarray testing. 17 patients had the same organisms detected on culture and array. 16 of these 17 had additional organisms detected by array. The most frequent organisms detected on array that were not detected by culture were Staphylococcus spp., Enterobacter, Pseudomonas and fungi. Conclusion. TaqMan array shows promise in detecting infecting organisms from diabetic foot wounds and providing earlier results than standard culture, which may enable appropriate and timely antibiotic therapy


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 24 - 24
1 Dec 2017
Johnson-Lynn S Ramaskandhan J Siddique M
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The effect of BMI on patient-reported outcomes following total ankle replacement (TAR) is uncertain and the change in BMI experienced by these patients in the 5 years following surgery has not been studied. We report a series of 106 patients with complete 5-year data on BMI and patient-reported outcome scores. Patients undergoing TAR between 2006 and 2009, took part in the hospital joint registry, which provides routine clinical audit of patient progress following total joint arthroplasty; therefore, ethics committee approval was not required for this study. Data on BMI, Foot and Ankle Score (FAOS) and SF-36 score were collected preoperatively and annually postoperatively. Patients who were obese (BMI >30) had lower FAOS scores pre-operatively and at 5 years, however this did not reach significance. Both obese (p = 0.0004) and non-obese (p < 0.0001) patients demonstrated a significant improvement in FAOS score from baseline to 5 years. This improvement was more marked for the non-obese patients. No significant differences were seen for SF36 scores between obese and non-obese patients either at baseline or 5 years. There was a trend for improved score in both groups. Mean pre-operative BMI was 28.49. Mean post-operative BMI was 28.33. The mean difference between pre- and post-operative BMI was −0.15, which was not statistically significant (p=0.55). There were no significant differences in revisions in the obese (2) and non-obese (1 and one awaited) groups at 5 years. This data supports use of TAR in the obese population, as significant increases in mean FAOS score were seen in this group at 5 years. Obesity did not have a significant influence on patients' overall health perceptions, measured by the SF36 and a trend for improvement was seen in both obese and non-obese patients. TAR cannot be relied upon to result in significant post-operative weight-loss without further interventions


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 46 - 52
1 Jan 2024
Hintermann B Peterhans U Susdorf R Horn Lang T Ruiz R Kvarda P

Aims

Implant failure has become more common as the number of primary total ankle arthroplasties (TAAs) performed has increased. Although revision arthroplasty has gained attention for functional preservation, the long-term results remain unclear. This study aimed to assess the long-term outcomes of revision TAA using a mobile-bearing prosthesis in a considerably large cohort; the risk factors for failure were also determined.

Methods

This single-centre retrospective cohort study included 116 patients (117 ankles) who underwent revision TAA for failed primary TAA between July 2000 and March 2010. Survival analysis and risk factor assessment were performed, and clinical performance and patient satisfaction were evaluated preoperatively and at last follow-up.


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.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 7 - 7
1 Dec 2017
Ahluwalia R Rhamen F Kavarthapu V
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Diabetes is a poor prognostic indicator after an ankle fracture. Many surgeons avoid operating due to concerns regarding complications. We performed a retrospective analysis of complication rates for acute ankle fractures in diabetics with a control non-diabetic patient treated by all surgeons in our unit and assessed factors for success including long-segment fixation. Patient records were cross-referenced with departmental databases and a review of all ankle fractures managed in our department was conducted from 2012. All patients subjected to a retrospective-review of their follow-up for at least 6-months. Radiographs were assessed of the ankle before and at completion of treatment being reviewed independently (RA & FR). We identified the HB1Ac (diabetic-control) and systematic co-morbidities. Fractures were classified into unimalleolar, bi malleolar and trimalleolar and surgery grouped into standard or long-segment-rigid fixation. Statistical analysis was conducted using absolute/relative risk (RR); numbers needed to treat (NNT) were calculated. We compared a control-group, a diabetic group managed conservatively, and undergoing surgery; comparing the concept of rigid fixation and prolonged imobilisation in isolation or combined. Further sub-analysis conducted assessing diabetic neuropathy, retinopathy and nephropathy. Ethics approval was granted as per our institutional policy by our governance lead. We identified 154 diabetic ankle fractures, seventy-six had conservative-treatment; 78 had operative fixation of which 23 had rigid-long-segment-fixation. The diabetic-groups had a higher risk-relative-risk of complication − 3.2 (P< 0.03) being linked to systematic complications of diabetes e.g. neuropathy 5.8 (P< 0.003); HBA1c 4.6 P< 0.004); and neuropathy or retinopathy 6.2 (P< 0.0003). Relative-risk reduction of complications occurred following surgery with prolonged immobilization (0.86) and rigid-fixation (0.65). The Number-Needed-to-Treat required to see a benefit from rigid fixation was 7. Diabetics have a higher risk for complications, however the risk is not as great as previously reported. We provide evidence of rigid-long-segment-fixation with prolonged-immobilization improving-outcomes


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. 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).


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.


Bone & Joint Research
Vol. 11, Issue 4 | Pages 189 - 199
13 Apr 2022
Yang Y Li Y Pan Q Bai S Wang H Pan X Ling K Li G

Aims

Treatment for delayed wound healing resulting from peripheral vascular diseases and diabetic foot ulcers remains a challenge. A novel surgical technique named ‘tibial cortex transverse transport’ (TTT) has been developed for treating peripheral ischaemia, with encouraging clinical effects. However, its underlying mechanisms remain unclear. In the present study, we explored the potential biological mechanisms of TTT surgery using various techniques in a rat TTT animal model.

Methods

A novel rat model of TTT was established with a designed external fixator, and effects on wound healing were investigated. Laser speckle perfusion imaging, vessel perfusion, histology, and immunohistochemistry were used to evaluate the wound healing processes.


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.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 2 - 2
1 Jan 2014
Shamsuddin M McCarthy I Singh D Goldberg A
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Aims:. With the advent of standing CT and MRI scans, there is increasing interest in establishing the role and usefulness of these investigations. When ordering a standing investigation, we assume that 100% of body weight is loaded through the limb, but most machines have handlebars for support and some have seats to allow patients the opportunity to sit. The aim of this study was to evaluate the amount of load going through the lower limbs in various positions supported and unsupported, to explore the range and variation in measurements obtained. Methods:. Following ethics and local IRB approval, 40 healthy volunteers were asked to stand on an electronic weighing scales and be measured for height. They were then asked to stand on an identical electronic weighing scale on the PedCAT standing CT. Their weight was measured single and double leg stance, with the hands supported and unsupported on the side bars. The subjects were then asked to sit with a single and then both legs on the scale. Results:. 40 subjects participated. 28 were female, average BMI 25.8 (4.98). By holding on to the hand rails between 10–20% (2.0) of body weight was removed. Single stance meant 85% (4.0) of body weight went through the single limb and by sitting, with the single limb on the scanner only 8.8% (2.3) of body weight goes through the limb. Conclusions:. Standing CT and MRI are increasing in popularity. We now know that in standing the majority of body weight is transferred to the limbs, but if the subject is holding onto support up to 20% of body weight is removed. If the subject is sitting then only 9% of body weight goes through the single limb. This information will help inform future studies that use weight bearing MRI or CT


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 34 - 34
1 Jan 2014
Refaie R Chong M Murty A Reed M
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Introduction:. Symptomatic treatment of ankle osteoarthritis (OA) with corticosteroid injections is well established. Hyaluronic acid is also reported as an effective symptomatic treatment for ankle OA but these two treatments have not been compared directly. Methods:. A prospective randomised controlled trial in patients with symptomatic ankle osteoarthritis. Twenty patients per group were required based on a significance level of 0.05, and a drop out rate of 5%. Patients were blindly allocated to the treatment or control group. Injections were carried out by the clinician in the outpatient department. Treatment group received Ostenil 20 mg and control group received Depomedrone 40 mg (both as single injections). The treatment arm was allocated by computer generated block randomization to match treatment allocation with grade of arthritis. The primary outcome measure was the change in Visual Analogue Scale (VAS) pain score at 6 months. Secondary outcome was the change in AOFAS score at 6 months. Research ethics committee approval was obtained. Results:. A total of 42 patients were recruited of which 38 completed the study. Male recruits predominated (79%; 33 recruits). More than 70% had radiographic OA of grade 3 or more. Both groups demonstrated statistically significant improvements in VAS at weeks 3, 6, and 3 months over baseline, but the Ostenil group faired better at 6 months follow-up. (difference in VAS scores of 3.5 Ostenil VAS − 4; Steroid VAS − 7.5; Mann Whitney test (p<=0.05). There was no statistical difference in AOFAS scores between both groups at baseline and follow-up (p=0.48, Mann Whitney test). No complications noted. 30% of patients have had their surgical procedures delayed for 6 month post injection. Conclusion:. The Ostenil group revealed similar clinical efficacy to steroid group, however the benefits provided by Ostenil lasted longer. Ostenil provided sufficient mid-term pain-relief whilst patient awaits further definitive intervention


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 68 - 75
1 Jan 2022
Harris NJ Nicholson G Pountos I

Aims

The ideal management of acute syndesmotic injuries in elite athletes is controversial. Among several treatment methods used to stabilize the syndesmosis and facilitate healing of the ligaments, the use of suture tape (InternalBrace) has previously been described. The purpose of this study was to analyze the functional outcome, including American Orthopaedic Foot & Ankle Society (AOFAS) scores, knee-to-wall measurements, and the time to return to play in days, of unstable syndesmotic injuries treated with the use of the InternalBrace in elite athletes.

Methods

Data on a consecutive group of elite athletes who underwent isolated reconstruction of the anterior inferior tibiofibular ligament using the InternalBrace were collected prospectively. Our patient group consisted of 19 elite male athletes with a mean age of 24.5 years (17 to 52). Isolated injuries were seen in 12 patients while associated injuries were found in seven patients (fibular fracture, medial malleolus fracture, anterior talofibular ligament rupture, and posterior malleolus fracture). All patients had a minimum follow-up period of 17 months (mean 27 months (17 to 35)).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 2 - 2
1 Sep 2012
Hickey B Morgan A Singh R Pugh N Perera A
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Introduction. The incidence of deep venous thrombosis (DVT) in patients with lower limb cast immobilization occurs in up to 20% of patients. This may result from altered calf pump function causing venous stasis. Our aim was to determine the effects of below knee cast on calf pump function. Method. Nine healthy participants were enrolled in this research and ethics approved prospective study. Four foot and ankle movements (toe dorsiflexion, toe plantar flexion, ankle dorsiflexion, ankle plantar flexion) and weight bearing were performed pre and post application of a below knee cast. Baseline and peak systolic velocity within the popliteal vein was measured during each movement. Participants with peripheral vascular disease, varicose veins, deep venous thrombosis or previous foot and ankle surgery were excluded. Results. The mean patient age was 34 years (range 28–58), the majority were female (n = 6). With cast in situ all movements resulted in a statistically significant increase in peak systolic velocity (p = <0.05). There was no significant difference in peak systolic velocity at the popliteal vein pre or post cast application. Discussion. This is the first study to examine the effect of a lower limb cast on calf muscle pump function. Despite cast immobilisation, toe and ankle flexion and extension movements significantly increase peak systolic velocity measured at the popliteal vein. Conclusion. Toe and ankle flexion and extension exercises significantly increase calf pump function in patients with below knee cast immobilization. We recommend that all patients treated in below knee cast immobilisation are advised to perform regular toe and ankle exercises to reduce venous stasis and risk of deep venous thromboembolism


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 43 - 43
1 May 2012
Kotwal R Paringe V Rath N Lyons K
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Injury to the syndesmosis occurs in approximately 10% of all patients with ankle fractures. Anatomic restoration of the syndesmosis is the only significant predictor of functional outcome. Several techniques of syndesmosis fixation are currently used such as cortical screws, bioabsorbable screws and more recently introduced suture-button fixation. No single technique has been shown to be superior to the others. The objective of this research project is to investigate whether treatment with a tightrope (suture-button fixation) gives superior results than the use of a cortical screw in the treatment of acute syndesmotic ankle injuries with regards to function, pain, satisfaction and return to normal activities. Research Ethics Committee approval was obtained. 40 patients with syndesmotic ankle injuries associated with diastasis were prospectively recruited, 20 in each group. Patients were randomized to one of the 2 groups. At 12 weeks, American Orthopaedic Foot and Ankle Society (AOFAS) scores and a computerized tomography (CT) scan of both the ankles was obtained. At 1 year, AOFAS scores and satisfaction was assessed. 32 patients have been recruited so far, 20 in the tightrope group and 12 in the cortical screw group. Mean AOFAS scores at 3 months post-op were 90.67 in the Tightrope group and 84 in the screw group. The difference was not significant (p= 0.096). CT scans revealed that the quality of syndesmosis reduction was equally good with both the techniques. Metalwork prominence was common with both the devices. Discussion and Conclusion. Both the devices achieved good reduction of the syndesmosis. Our CT scan protocol has insignificant radiation risk and allows more accurate assessment of the syndesmosis. Early clinical results do not show a significant difference in the functional outcome with the use of either device. Long-term (1 year) follow-up has been planned


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 1 - 1
1 Sep 2012
Hickey B Morgan A Jones H Singh R Pugh N Perera A
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Introduction. The muscles of the leg collectively comprise the calf pump, however the action of each muscle group on calf pump function is not known. Patients with foot or ankle injury or surgery are often advised to perform foot and ankle movements to help prevent deep venous thrombosis. Our aim was to determine which foot and ankle movements were most effective in stimulating the calf pump. Method: Nine healthy participants were enrolled in this research and ethics approved prospective study. Participants with a previous history of peripheral vascular disease, varicose veins, deep venous thrombosis or previous foot and ankle surgery were excluded. Each participant followed a standardized protocol of foot and ankle movements, starting with foot in neutral position and the baseline and movement peak systolic velocity within the popliteal vein was measured during each movement. The movements tested were toe dorsiflexion, toe plantar flexion, ankle dorsiflexion, ankle plantar flexion. Results. The mean patient age was 34 years (range 28–58), the majority were female (n = 6). All movements resulted in statistically significant changes in peak systolic velocity (p = <0.05). In order of decreasing peak velocity the exercises which had greatest effect on calf pump function were: Ankle dorsiflexion (101cm/s), Ankle plantarflexion (84cm/s), Toe dorsiflexion (63cm/s), Toe plantarflexion (59cm/s). We have shown that all four exercises significantly increased calf pump function. The greatest effect was seen with ankle movements. Conclusion. Toe and ankle flexion and extension exercises significantly increase calf pump function and should be advised for all patients following foot or ankle injury and surgery as this may reduce venous stasis and risk of venous thromboembolism


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 59 - 59
1 May 2012
Paringe V Vannet N Ferran N Gandour A
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ECSWT has been on the medical horizon for last 30 years mainly in urology for urolithiasis and has found a parallel use in orthopaedics for various chronic soft tissue conditions like Tendoachilles tendinoses and plantar fasciitis etc. ECSWT acts a piezoelectric device releasing acoustic energy and causing micro-trauma activating cytokine mediated response stimulating local angiogenesis and tissue repair. Methodology. 56 patients were recruited for the trial after ethics approval was achieved. The diagnosis was confirmed with ultrasound scan and measuring the width of the swelling and the local hypervascularity. The cohort of the patients was randomised in groups for physiotherapy [n=23] and shockwave therapy [n= 23]. The patient groups with shockwave therapy received a 3-week treatment with typical 2000 impulses per session once a week and physiotherapy group was subjected to eccentric loading exercises. Patients were assessed at 12 week with AOFAS, VISA-A scores and repeat ultrasound scan. Results. The average age of the average age was 51 years [36- 73 years] Mean duration of symptoms prior to treatment was 25 months (range 6-60 months). AOFAS scores increased in both groups: from 64□86 in the ECSWT group and 72□79 in the physiotherapy group. VISA-A scores also increased in both groups from 39□73 in the ECSWT group and from 36□56 in the physiotherapy group. Scores were significantly higher in the ECWST group post treatment. The ultrasound scan findings suggested the tendon girth receding from 10.9 mm□9.9 mm in physiotherapy group while 9.8 mm□8.7 mm in the ECSWT group with hypervascularity decreasing from marked to mild in both groups. Statistical significance was established using SPSS 16 p < 0.001in post treatment group. Conclusion. Clinically significant improvement was found in the patients treated with ECSWT as compared to the physiotherapy sessions while radiological evidence showed parallel improvement in both the groups


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.