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The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1256 - 1265
1 Nov 2022
Keene DJ Alsousou J Harrison P O’Connor HM Wagland S Dutton SJ Hulley P Lamb SE Willett K

Aims. To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. Methods. A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat. Results. A total of 230 participants were randomized, 114 to PRP and 116 to placebo. Two-year questionnaires were sent to 216 participants who completed a six-month questionnaire. Overall, 182/216 participants (84%) completed the two-year questionnaire. Participants were aged a mean of 46 years (SD 13.0) and 25% were female (57/230). The majority of participants received the allocated intervention (219/229, 96%). Mean ATRS scores at two years were 82.2 (SD 18.3) in the PRP group (n = 85) and 83.8 (SD 16.0) in the placebo group (n = 92). There was no evidence of a difference in the ATRS at two years (adjusted mean difference -0.752, 95% confidence interval -5.523 to 4.020; p = 0.757) or in other secondary outcomes, and there were no re-ruptures between 24 weeks and two years. Conclusion. PRP injection did not improve patient-reported function or quality of life two years after acute Achilles tendon rupture compared with placebo. The evidence from this study indicates that PRP offers no patient benefit in the longer term for patients with acute Achilles tendon rupture. Cite this article: Bone Joint J 2022;104-B(11):1256–1265


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 3 - 3
10 Jun 2024
Alsousou J Keene D Harrison P O'Connor H Wagland S Dutton S Hulley P Lamb S Willett K
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Background. The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture. Study design. Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial. Methods. Adults with acute ATR managed non-surgically were recruited in 19 UK hospitals from 2015 to 2019. Exclusions were insertion or musculotendinous injuries, leg injury or deformity, diabetes, haematological disorder, corticosteroids and anticoagulation therapy. Participants were randomised via an online system 1:1 to PRP or placebo. Primary outcome was Achilles Tendon Rupture Score (ATRS) at two-years. Secondary outcomes were pain, Patient-Specific Functional Scale (PSFS), SF-12 and re-rupture. Assessors were blinded. Intention-to-treat and Compliance Average Causal effects (CACE) analyses were carried out. Consistency of effects across subgroups age, BMI, smoking and gender were assessed using Forest plots. Pearson's correlation was used to explore ATRS correlation with blood and growth factors. Results. 216/230 (94%) participants completed the 6-months follow-up were contacted. 182/216 (84%) completed the two-year follow-up. Participants were aged mean 46 (SD 13.0), 57 female/159 male. 96% received the allocated intervention. Two-years ATRS scores were 82.2 (SD 18.3) in the PRP group (n=85) and 83.8 (SD 16.0) in the placebo group (n=92). There was no evidence of a difference in the two-years ATRS (adjusted-mean difference −0.752 95%CI −5.523 to 4.020, p=0.757), or in any secondary outcome, and no re-rupture between at two-years. Neither PRP cellular or growth factors correlated with the two-year ATRS. Conclusion. PRP did not improve patient-reported function or quality of life two-years after acute Achilles tendon rupture, compared with placebo, indicating that PRP offers no patient benefit in the longer term


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 5 - 5
1 Jun 2023
Church D Pawson J Hilton C Fletcher J Wood R Brien J Vris A Iliadis A Collins K Lloyd J
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Introduction. External fixators are common surgical orthopaedic treatments for the management of complex fractures and in particular, the use of circular frame fixation within patients requiring limb reconstruction. It is well known that common complications relating to muscle length and patient function without rehabilitation can occur. Despite this there remains a lack of high-quality clinical trials in this area investigating the role of physiotherapy or rehabilitation in the management of these patients. We aim to complete a systematic review of rehabilitation techniques for patients undergoing external fixator treatment for Limb Reconstruction of the lower limb. Materials & Methods. A comprehensive search of AMED, CINAHL, MEDLINE and COCHRANE databases was conducted to identify relevant articles for inclusion, using a search strategy developed in collaboration with a research librarian. Inclusion criteria consisted of adults aged 18 years and over who have experienced leg trauma (open fracture, soft tissue damage), elective leg deformity corrective surgery, bone infection or fracture non-union who have been treated with the use of an external fixator for fixation. Specific exclusion criteria were patients below the age of 18 years old, patients with cancer, treatment of the injury with internal nail, patients who underwent amputation, the use of external fixators for soft tissue contracture management, editorials, comment papers, review papers, conference proceedings and non-English papers. Titles, abstracts, and full texts were screened for suitability by pairs of reviewers according to the inclusion and exclusion criteria using Rayyan QCRI online software. Any conflicts were resolved through discussion with three independent specialist senior reviewers. Following full text screening, references lists of included articles were manually searched to ensure that all relevant studies were identified. Due to lack of evidence, forward searching was also completed for studies included in the review. Data quality was assessed using the mixed methods appraisal tool and the CERT assessment tool was utilised to look at completeness of reporting of exercise interventions. Results. A total number of 832 articles were initially retrieved from our search once duplicate articles removed. After title and abstract screening, 45 articles remained for full text screening. Of these, 11 articles met our inclusion criteria and included for data extraction. Conclusions. We expect high variability of results due to our inclusion criteria and therefore plan to conduct a narrative synthesis to summarise the findings whilst measing against the mixed methods appraisal tool and CERT assessment scores to assess the data quality. We anticipate lower assessment scores within the fewer articles found and therefore poorer-quality data. We currently are in the process of finalising this data extraction. This will be completed ready for submission and potential presentation at the BLRS conference in March 2023


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_21 | Pages 9 - 9
1 Apr 2013
Ramasamy A Masouros S Phillip R Gibb I Bull A Clasper J
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Background. The conflict in Afghanistan has been epitomised by the emergence of the Improvised Explosive Device (IEDs). Improvements in protection and medical treatments have resulted in increasing numbers of casualties surviving with complex lower extremity injuries. To date, there has been no analysis of foot and ankle blast injuries as a result of IEDs. Therefore the aims of this study are to report the pattern of injury and determine which factors were associated with a poor clinical outcome. Methods. Using a prospective trauma registry, UK Service Personnel who sustained lower leg injuries following an under-vehicle explosion between Jan 2006 and Dec 2008 were identified. Patient demographics, injury severity, the nature of lower limb injury and clinical management was recorded. Clinical endpoints were determined by . (i). need for amputation and. (ii). need for ongoing clinical output at mean 33.0 months follow-up. Results. 63 UK Service Personnel (89 injured limbs) were identified with lower leg injuries from explosion. 50% of casualties sustained multi-segmental injuries to the foot and ankle complex. 26(29%) limbs required amputation, with six amputated for chronic pain 18 months following injury. Regression analysis revealed that hindfoot injuries, open fractures and vascular injuries were independent predictors of amputation. Of the 69 limbs initially salvaged, the overall infection rate was 42%, osteomyelitis 11.6% and non-union rates was 21.7%. Symptomatic traumatic osteoarthritis was noted in 33.3% salvaged limbs. At final follow-up, 66(74%) of injured limbs had persisting symptoms related to their injury, with only 9(14%) fit to return to their pre-injury duties. Conclusions. This study demonstrates that foot and ankle injuries from IEDs are frequently associated with a high amputation rate and poor clinical outcome. Although, not life-threatening, they remain a source of long-term morbidity in an active population. Primary prevention of these injuries remain key in reducing the injury burden


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 56 - 56
1 Jan 2013
Ramasamy A Hill A Masouros S Gibb I Phillip R Bull A Clasper J
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The conflict in Afghanistan has been epitomised by the emergence of the Improvised Explosive Device(IEDs). Improvements in medical treatments have resulted in increasing numbers of casualties surviving with complex lower extremity injuries. To date, there has been no analysis of foot and ankle blast injuries as a result of IEDs. Therefore the aims of this study are to firstly report the pattern of injury and secondly determine which factors were associated with a poor clinical outcome in order to focus future research. Using a prospective trauma registry, UK Service Personnel who sustained lower leg injuries following an under-vehicle explosion between Jan 2006 and Dec 2008 were identified. Patient demographics, injury severity, the nature of lower limb injury and clinical management was recorded. Clinical endpoints were determined by (i)need for amputation and (ii)need for ongoing clinical output at mean 33.0 months follow-up. 63 UK Service Personnel (89 injured limbs) were identified with lower leg injuries from explosion. 50% of casualties sustained multi-segmental injuries to the foot and ankle complex. 26(29%) limbs required amputation, with six amputated for chronic pain 18 months following injury. Regression analysis revealed that hindfoot injuries, open fractures and vascular injuries were independent predictors of amputation. Of the 69 limbs initially salvaged, the overall infection rate was 42%, osteomyelitis 11.6% and non-union rates was 21.7%. Symptomatic traumatic osteoarthritis was noted in 33.3% salvaged limbs. At final follow-up, 66(74%) of injured limbs had persisting symptoms related to their injury, with only 9(14%) fit to return to their pre-injury duties. This study demonstrates that foot and ankle injuries from IEDs are frequently associated with a high amputation rate and poor clinical outcome. Although, not life-threatening, they remain a source of long-term morbidity in an active population. Primary prevention of these injuries remain key in reducing the injury burden


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_8 | Pages 16 - 16
1 Feb 2013
Ramasamy A Hill A Phillip R Gibb I Bull A Clasper J
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The defining weapon of the conflicts in Iraq and Afghanistan has been the Improvised Explosive Device (IEDs). When detonated under a vehicle, they result in significant axial loading to the lower limbs, resulting in devastating injuries. Due to the absence of clinical blast data, automotive injury data using the Abbreviated Injury Score (AIS) has been extrapolated to define current NATO injury thresholds for Anti-vehicle (AV) mine tests. We hypothesized that AIS, being a marker of fatality rather than disability would be a worse predictor of poor clinical outcome compared to the lower limb specific Foot and Ankle Severity Score (FASS). Using a prospectively collected trauma database, we identified UK Service Personnel sustaining lower leg injuries from under-vehicle explosions from Jan 2006–Dec 2008. A full review of all medical documentation was performed to determine patient demographics and the severity of lower leg injury, as assessed by AIS and FASS. Clinical endpoints were defined as (i) need for amputation or (ii) poor clinical outcome. Statistical models were developed in order to explore the relationship between the scoring systems and clinical endpoints. 63 UK casualties (89 limbs) were identified with a lower limb injury following under-vehicle explosion. The mean age of the casualty was 26.0 yrs. At 33.6 months follow-up, 29.1% (26/89) required an amputation and a further 74.6% (41/89) having a poor clinical outcome (amputation or ongoing clinical problems). Only 9(14%) casualties were deemed medically fit to return to full military duty. ROC analysis revealed that both AIS=2 and FASS=4 could predict the risk of amputation, with FASS = 4 demonstrating greater specificity (43% vs 20%) and greater positive predictive value (72% vs 32%). In predicting poor clinical outcome, FASS was significantly superior to AIS (p<0.01). Probit analysis revealed that a relationship could not be developed between AIS and the probability of a poor clinical outcome (p=0.25). Foot and ankle injuries following AV mine blast are associated with significant morbidity. Our study clearly demonstrates that AIS is not a predictor of long-term clinical outcome and that FASS would be a better quantitative measure of lower limb injury severity. There is a requirement to reassess the current injury criteria used to evaluate the potential of mitigation technologies to help reduce long-term disability in military personnel. Our study highlights the critical importance of utilising contemporary battlefield injury data in order to ensure that the evaluation of mitigation measures is appropriate to the injury profile and their long-term effects


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 7 - 7
1 Mar 2010
Selby R Geerts WH Kreder HJ Crowther MA Bent M Schemitsch EH Weiler P Kaus L Sealey F Jay R
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Purpose: We conducted the first, multicentre, prospective cohort study to define the incidence of symptomatic venous thromboembolism (VTE) in patients with tibia and ankle fractures treated conservatively and relatively minor lower leg fractures. The reported incidence of deep vein thrombosis (DVT) using routine venography in patients with lower leg injury requiring cast immobilization is approximately 20–40%, which has lead to the routine use of anticoagulant prophylaxis for several weeks in many such patients. However the vast majority of venographically-detected DVTs are asymptomatic, distal thrombi whose clinical relevance is uncertain. Therefore venography is not the best outcome measure to assess the burden of clinically important VTE. Method: Consecutive patients with tibia and fibula fractures (treated non-operatively) and patella and foot fractures, (treated operatively or conservatively) were assessed for eligibility at 5 Ontario hospitals. Patients were enrolled after informed consent within 96 hours of injury and were followed prospectively, by telephone, at 2, 6 and 12 weeks. Those with major trauma, active cancer, and previous VTE were excluded. Thromboprophylaxis was not allowed. Education regarding symptoms of VTE was provided at study entry and patients were asked about VTE symptoms at follow up. Suspected VTE was investigated in a standardized manner. Results: From August 2002 to June 2005, 1200 patients were enrolled from 2446 consecutively screened patients. 98% of patients completed 3-month follow-up. The mean age was 45 years (16 to 93) and 60% were female. The most common fractures were fibular (39%) and most injuries were caused by falls (75%). 99 % of these fractures were unilateral. Most fractures did not require surgical repair (93%), and 82% of patients were immobilized by cast or splint for an average of 42 ±32 days. Overall, 7 patients had symptomatic, objectively confirmed VTE (2 proximal DVT, 3 calf DVT, 2 PE) with no fatal PE – an incidence of 0.6 % (95% CI 0.2 to 1.2). Conclusion: Symptomatic VTE is an infrequent complication after these fractures without thromboprophylaxis. Therefore routine thromboprophylaxis is neither warranted, nor likely to be cost-effective in these patients. This study also highlights the significant discrepancy between clinical endpoint studies and studies using venography


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 184 - 184
1 Mar 2006
Mushtaq S Kotwal A Pavlou G Giannoudis P Branfoot T
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Introduction: Although the functional outcomes after severe lower limb injury ( Gustilo grade IIIb and IIIc ) managed with various surgical techniques is well described in the literature, there is limited information on appearance related psychological impact after complex lower limb reconstruction. We sought to determine the aesthetic problems in patients with open tibial fractures with extensive soft tissue injury. Materials and methods: Data on patients with open tibial fractures managed with free flaps between 1999–2003 admitted to our trauma unit was collected and analysed. Patients who had finished their treatment at least one year ago with isolated leg injury were identified, patients with surgery related disability were excluded. we used Derriford Scale (DSA24) with additional questionnaire for analysis . Results: In total 31 patients were contacted out of which 18 provided with completed questionnaires, 14 male and 4 female with mean age of 41.8(17–69) year. Appearance of the leg following surgery significantly effected relationships (3 divorced, 2 split up, 3 worse, 8 same and 2 better). Nine (56.2%) patients experienced poor sexual relationship following surgery and four (22.2%) reported to avoid undressing in front of partners. Five patients (27.7%) requested debunking and two under went surgery. Twelve (66.6%) patients were still taking pain killers. Ten (55.5%) patient complained of donor site weakness or painful scar. Six (33.3%) patients required to change jobs. Thirteen (72.2%) were unconfident in themselves, (66.6%) were distressed to see there legs in mirror. Nine (50%) felt hurt and irritable at home, (61.1%) patients avoided going to beach. Nine (50%) disliked using communal changing areas or even going for shopping and felt closed in a shell. Eight (44.4%) patients felt rejected and chose not to attend social events. Conclusion: The psychological impact of trauma is generally neglected, sudden and unexpected nature of events and interventions have significant effect on post operative quality of life


Bone & Joint 360
Vol. 7, Issue 4 | Pages 28 - 31
1 Aug 2018


The Bone & Joint Journal
Vol. 100-B, Issue 1 | Pages 88 - 94
1 Jan 2018
Sprague S Petrisor B Jeray K McKay P Heels-Ansdell D Schemitsch E Liew S Guyatt G Walter SD Bhandari M

Aims

The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap versus normal saline) and irrigation pressure (very low versus low versus high) on health-related quality of life (HRQL) in patients with open fractures. In this study, we used this dataset to ascertain whether these factors affect whether HRQL returns to pre-injury levels at 12-months post-injury.

Patients and Methods

Participants completed the Short Form-12 (SF-12) and the EuroQol-5 Dimensions (EQ-5D) at baseline (pre-injury recall), at two and six weeks, and at three, six, nine and 12-months post-fracture. We calculated the Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 and the EQ-5D utility score, conducted an analysis using a multi-level generalized linear model, and compared differences between the baseline and 12-month scores.


Bone & Joint 360
Vol. 1, Issue 4 | Pages 24 - 26
1 Aug 2012

The August 2012 Trauma Roundup360 looks at: pelvic fractures, thromboembolism and the Japanese; venous thromboembolism risk after pelvic and acetabular fractures; the displaced clavicular fracture; whether to use a nail or plate for the displaced fracture of the distal tibia; the dangers of snowboarding; how to predict the outcome of lower leg blast injuries; compressive external fixation for the displaced patellar fracture; broken hips in Morocco; and spinal trauma in mainland China.