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The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 858 - 864
1 Aug 2024
Costa ML Achten J Knight R Campolier M Massa MS

Aims

The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial.

Methods

The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and health-related quality of life, chronic pain scores and neuropathic pain scores annually, using a self-reported questionnaire. Complications, including further surgery related to the fracture, were also recorded.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 705 - 712
1 Jul 2024
Karlsson T Försth P Öhagen P Michaëlsson K Sandén B

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

Methods

The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.


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. 106-B, Issue SUPP_6 | Pages 51 - 51
2 May 2024
Diffley T Yee T Letham C Ali M Cove R Mohammed I Kindi GA Samara A Cunningham C
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Extracapsular Hip Fractures (EHF's) are a significant health burden on healthcare services. Optimal treatment is controversial with conflicting evidence being reported. Currently treatment is undertaken with Intramedullary Nail (IMN) or Dynamic Hip Screw (DHS) constructs with a recent increase in IMN use (1). This study aims to conduct a systematic review of Randomised Control Trials published between 2020 and 2023 with particular focus on patient demographics and holistic patient outcomes. Using a unified search-protocol, RCT's published between 2020 and 2023 were collected from CENTRAL, PubMed, MEDLINE and EMBASE. Rayyan software screened duplicates. Using the CASP and Cochrane Risk of Bias Tool papers were critically examined twice, and Blood Loss, Infection and Mobility described the patient journey. Patient demographics were recorded and were contrasted with geographically diverse cohort studies to compare population differences. Parametric tests were used to determine significance levels between population demographics, namely Age and Sex. Eleven papers were included, representing 908 patients (436 Male). The mean age for patients was 64.39. There was considerable risk of bias in 7/11 studies owing to the randomization process and the recording of data. Four Cohort studies were selected for comparison representing 14314 patients. Mean age was significantly different between Cohort Studies and RCT's (Independent T-Test, df 13, t=7.8, p = <0.001, mean difference = 19.251, 95% CI = 13.888, 24.613). This was also true for sex ratios included in the studies (df 13, t = -2.268, p = 0.024, Mean Difference = -0.4884, 95% CI = -0.9702, -0.0066). To conclude, RCT's published in the post COVID-19 era are not representative of patient demographics. This has the potential to provide inaccurate information for implant selection. Additionally further research must be conducted in how to better improve RCT patient inclusion so as to be more representative of patients whilst balancing the risks of operations


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 450 - 459
1 May 2024
Clement ND Galloway S Baron J Smith K Weir DJ Deehan DJ

Aims

The aim was to assess whether robotic-assisted total knee arthroplasty (rTKA) had greater knee-specific outcomes, improved fulfilment of expectations, health-related quality of life (HRQoL), and patient satisfaction when compared with manual TKA (mTKA).

Methods

A randomized controlled trial was undertaken (May 2019 to December 2021), and patients were allocated to either mTKA or rTKA. A total of 100 patients were randomized, 50 to each group, of whom 43 rTKA and 38 mTKA patients were available for review at 12 months following surgery. There were no statistically significant preoperative differences between the groups. The minimal clinically important difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was defined as 7.5 points.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 515 - 515
1 May 2024
Kayani B D. Luo T S. Haddad F


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 307 - 311
1 Apr 2024
Horner D Hutchinson K Bretherton CP Griffin XL


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 108 - 110
1 Feb 2024
Haddad FS


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 114 - 120
1 Feb 2024
Khatri C Metcalfe A Wall P Underwood M Haddad FS Davis ET

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies. Cite this article: Bone Joint J 2024;106-B(2):114–120


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_15 | Pages 50 - 50
7 Nov 2023
Bell K Oliver W White T Molyneux S Clement N Duckworth A
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This systematic review and meta-analysis aimed to compare the outcome of operative and non-operative management in adults with distal radius fractures, with an additional elderly subgroup analysis. The main outcome was 12-month PRWE score. Secondary outcomes included DASH score, grip strength, complications and radiographic parameters. Randomised controlled trials of patients aged ≥18yrs with a dorsally displaced distal radius fractures were included. Studies compared operative intervention with non-operative management. Operative management included open reduction and internal fixation, Kirschner-wiring or external fixation. Non-operative management was cast/splint immobilisation with/without closed reduction. Version 2 of the Cochrane risk-of-bias tool was used. After screening 1258 studies, 16 trials with 1947 patients (mean age 66yrs, 76% female) were included in the meta-analysis. Eight studies reported PRWE score and there was no clinically significant difference at 12 weeks (MD 0.16, 95% confidence interval [CI] −0.75 to 1.07, p=0.73) or 12 months (mean difference [MD] 3.30, 95% CI −5.66 to −0.94, p=0.006). Four studies reported on scores in the elderly and there was no clinically significant difference at 12 weeks (MD 0.59, 95% CI −0.35 to 1.53, p=0.22) or 12 months (MD 2.60, 95% CI −5.51 to 0.30, p=0.08). There was a no clinically significant difference in DASH score at 12 weeks (MD 10.18, 95% CI −14.98 to −5.38, p<0.0001) or 12 months (MD 3.49, 95% CI −5.69 to −1.29, p=0.002). Two studies featured only elderly patients, with no clinically important difference at 12 weeks (MD 7.07, 95% CI −11.77 to −2.37, p=0.003) or 12 months (MD 3.32, 95% CI −7.03 to 0.38, p=0.08). There was no clinically significant difference in patient-reported outcome according to PRWE or DASH at either timepoint in the adult group as a whole or in the elderly subgroup


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 83 - 83
7 Aug 2023
Sidhu GAS
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Abstract. Introduction. Multiple strategies, used either in isolation or combination, are available to reduce the need for post-operative blood transfusion in joint replacements. Amongst them, the use of tranexamic acid (TXA) has been rising and this study was conducted to compare the efficacy of topical and intravenous TXA in bilateral total knee replacement patients. Materials and methods. Randomised prospective study with 120 patients (male: female: 25:95) undergoing bilateral TKA. Patients were divided into two groups A and B after computer randomization, who received intravenous or topical (intra-articular) TXA respectively. Results. The average haemoglobin loss in intravenous group was 90.2379 g/L as compared to 39.137 g/L in topical group (p < 0.005). Moreover, there was reduction in blood loss in topical (330.1602 ml) as compared to intravenous group (764.9622 ml). The blood transfusion rate was more for the intravenous group (average 1.73 units) than for the topical group (average 0.75, unit). WOMAC score at 6 weeks in the intravenous group was 12.50, and in the topical group was 7.23 (p value < 0.001). Conclusion. Topical TXA is better than intravenous TXA for reduction of blood loss, which also reduces the need for blood transfusion in bilateral TKA patients


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 49 - 49
17 Apr 2023
Cooper G Kennedy M Jamal B Shields D
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Our objective was to conduct a systematic review and meta-analysis, comparing differences in clinical outcomes between either autologous or synthetic bone grafts in the operative management of tibial plateau fractures: a traumatic pattern of injury, associated with poor long-term functional prognosis. A structured search of MEDLINE, EMBASE, The Bone & Joint and CENTRAL databases from inception until 07/28/2021 was performed. Randomised, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture non-union or chondral defects were excluded. Outcome data was assessed using the Risk of Bias 2 (ROB2) framework and synthesised in random-effect meta-analysis. Preferred Reported Items for Systematic Review and Meta-Analysis guidance was followed throughout. Six comparable studies involving 352 patients were identified from 3,078 records. Following ROB2 assessment, five studies (337 patients) were eligible for meta-analysis. Within these studies, more complex tibia plateau fracture patterns (Schatzker IV-VI) were predominant. Primary outcomes showed non-significant reductions in articular depression at immediate postoperative (mean difference −0.45mm, p=0.25, 95% confidence interval (95%CI): −1.21-0.31mm, I. 2. =0%) and long-term (>6 months, standard mean difference −0.56, p=0.09, 95%CI: −1.20-0.08, I. 2. =73%) follow-up in synthetic bone grafts. Secondary outcomes included mechanical alignment, limb functionality, defect site pain, occurrence of surgical site infections, secondary surgery, perioperative blood loss, and duration of surgery. Blood loss was lower (90.08ml, p<0.001, 95%CI: 41.49-138.67ml, I. 2. =0%) and surgery was shorter (16.17minutes, p=0.04, 95%CI: 0.39-31.94minutes, I. 2. =63%) in synthetic treatment groups. All other secondary measures were statistically comparable. Our findings supersede previous literature, demonstrating that synthetic bone grafts are non-inferior to autologous bone grafts, despite their perceived disadvantages (e.g. being biologically inert). In conclusion, surgeons should consider synthetic bone grafts when optimising peri-operative patient morbidity, particularly in complex tibial plateau fractures, where this work is most applicable


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 36 - 36
23 Feb 2023
Ma N Gogos S Moaveni A
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Surgical site infections following orthopaedic surgery are a serious complication associated with increased morbidity and mortality. Intra-wound antibiotic powder may be able to provide infection prophylaxis locally with less systemic adverse effects, and promising results have been reported in systematic reviews of its use in spine surgery. This study aims to analyse the efficacy and adverse effect profile of intra-wound antibiotics in reducing surgical site infections in orthopaedic surgery for traumatic pelvic and lower limb fractures. A systematic review was conducted for studies reporting on the incidence of surgical site infections following administration of intra-wound antibiotic powder in pelvic and lower limb trauma surgery. Randomised controlled trials, cohort and case-control studies were included. A meta-analysis was conducted for deep surgical site infections. Seven studies were included in the systematic review including six retrospective case-control studies and one randomised controlled trial. Results of the meta-analysis suggest a potential 23% reduction in the odds of developing a deep surgical site infection in patients treated with intra-operative antibiotic powder compared with those managed with intravenous antibiotics alone (OR 0.77, 95% CI 0.52 – 1.13), although the results did not reach statistical significance. Notable selective bias against intra-wound antibiotics and suboptimal study design were found in the retrospective studies, however the randomised controlled trial reported a significant reduction in deep surgical site infections with intra-wound vancomycin powder. There were no reports of systemic adverse outcomes and minimal risk of wound complications with the use of intra-wound antibiotics. This review suggests the use of intra-wound antibiotic powder in pelvic and lower limb trauma surgery may reduce the incidence of deep surgical site infections. Further powered studies including randomised controlled trials are required to confirm the results highlighted in this study


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1148 - 1155
1 Oct 2022
Watts AC Hamoodi Z McDaid C Hewitt C

Aims

Arthroplasties of the elbow, including total elbow arthroplasty, radial head arthroplasty, distal humeral hemiarthroplasty, and radiocapitellar arthroplasty, are rarely undertaken. This scoping review aims to outline the current research in this area to inform the development of future research.

Methods

A scoping review was undertaken adhering to the Joanna Briggs Institute guidelines using Medline, Embase, CENTRAL, and trial registries, limited to studies published between 1 January 1990 and 7 February 2021. Endnote software was used for screening and selection, and included randomized trials, non-randomized controlled trials, prospective and retrospective cohort studies, case-control studies, analytical cross-sectional studies, and case series of ten or more patients reporting the clinical outcomes of elbow arthroplasty. The results are presented as the number of types of studies, sample size, length of follow-up, clinical outcome domains and instruments used, sources of funding, and a narrative review.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 58 - 58
1 Jul 2022
Joshi A Gupte C Bhattacharyya R Ahmad K Porteous A Murray J Murray J
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Abstract. Introduction. In recent years, CTA has been an effective training adjunct for orthopaedic procedures. ACLR is a complex procedure with a steep learning curve. Aim. To design a multimedia CTA learning tool for ACLR using a modified Delphi methodology. Methodology:. CTA generation: A modified Delphi method was used to generate a list of Technical Steps (TS), Decision Points (DP) and errors/solutions for an ACLR that was approved by an expert consensus amongst four, fellowship-trained knee surgeons. A technical workflow was designed to generate the audio-visual tool. Pilot study: 30 novice trainees were granted access to the CTA tool and then performed the ACLR in a cadaveric simulation workshop. A 5-point Likert scale aimed to qualitatively assess if the CTA was useful to their learning. Results:. CTA generation: 156 TS and 79 DP were included for an ACLR procedure which was divided into 7 phases. The audio-visual component was combined with the written tool to design the final CTA tool. Pilot study: 95% of trainees suggested the CTA tool would be useful before carrying out an ACLR in the operating theatre. They agreed it made their ACLR learning more effective. Conclusion:. We have designed a novel and easily accessible CTA tool to standardise teaching of ACLR surgery. Novice surgeons verify the value of the CTA as an adjunct to their apprenticeship training. Future work: A Randomised Controlled Trial (RCT) is currently being planned to evaluate whether there are any objective benefits of this CTA to train surgeons performing an ACLR


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 40 - 40
1 Jul 2022
Prodromidis A Chloros G Thivaios G Sutton P Veysi V Giannoudis P Charalambous C
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Abstract. Introduction. Higher than expected rates of tibial loosening with the ATTUNE® total knee arthroplasty (TKA) implant has been reported. Component loosening can be associated with the development of radiolucency lines (RLL) and our study aim was to systematically assess the reported rates of these. Methodology. A systematic search was undertaken using the Cochrane methodology in four online databases. Identified studies were assessed and screened against predetermined inclusion criteria. Meta-analysis was conducted using a random-effects model. Results. Nine studies (n=2,727 TKAs) from 6,590 titles met the inclusion criteria: 1 Randomised Controlled Trial (n=74), 1 prospective cohort (n=200), 4 retrospective cohort (n=1,639), and 3 case-series (n=814). All used the 2013 ATTUNE® design. In meta-analysis: 8 studies (n=1,440 ATTUNE TKAs) reported an overall prevalence of 11% (95%CI: 6.4-18.3%) for medial tibia RLL; 7 studies (n=940) a 12.3% (95%CI: 4.0-32%) rate of any tibia RLL.; 5 studies (n=736) femoral RLL in 11% (95%CI: 7.2-106.5%) and 7 studies (n=896) any RLL in 20.7% (95%CI: 13.4-30.6%). Meta-analysis of 4 studies (n=1,036) comparing the ATTUNE® with another implant (PFC Sigma®, LCS®, or PERSONA®) showed a higher risk of medial tibia RLL (OR: 2.538; 95%CI: 1.397-4.611, P=0.002) and any RLL (OR: 2.725; 95%CI: 1.302-5.703, P=0.008) in the ATTUNE® group. Conclusions. The 2013 ATTUNE® TKA system is associated with high rates of radiolucency around the tibial and femoral components. Comparative studies suggesting these rates are more than double those of other systems. Radiolucency may be a herald of component loosening, therefore, close surveillance of this implant is recommended


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 50 - 50
1 Jul 2022
Fontalis A Kayani B Asokan A Haddad IC Tahmassebi J Konan S Oussedik S Haddad FS
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Abstract. Introduction. The postoperative inflammatory response may be implicated in the aetiology of patient dissatisfaction following Total Knee Arthroplasty. Robotic-arm assisted TKA has been associated with reduced bone and soft tissue trauma. The objective of this Randomised Controlled Trial was to compare the inflammatory response in conventional Jig-based versus robotic arm-assisted TKA and examine the relationship with patient reported outcome measures and functional outcomes. Methodology. 30 patients with knee osteoarthritis were randomised to either conventional or robotic-arm assisted TKA. Blood samples were collected for up to 28 days post-operatively and intraarticular drain samples at 6 and 24 hours, to ascertain the systemic and local inflammatory responses. The Spearman's correlation was utilised to evaluate the relationship with PROMs and functional outcomes. Results. Reduced IL-6 drain fluid levels were noted at 6 hours [798.54 vs. 5699.2, p=0.026] and 24 hours and IL-8 at 6 hours. Patients in the robotic group had lower pain scores on post-operative day 1, 2 and 7. PROM scores were comparable at 2 years. Statistically significant correlations were evident between all serum markers except IL-1b on the 7th postoperative day and self-reported pain; between drain IL-8 levels and self-reported pain; between drain IL-6, IL-8 and TNF-a levels (6-hours) and knee flexion and extension. Conclusion. Robotic-arm assisted TKA was associated with a reduced postoperative local and systemic inflammatory responses. A moderate correlation with self-reported pain, knee flexion and extension was also demonstrated. Longer-term data and further validation on a larger scale, will be key to developing the optimal TKA procedure


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 19 - 19
1 Apr 2022
Lim A Zhu J Khanduja V
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There are a number of patients in whom hip preservation surgery is not indicated as they have developed signs of early osteoarthritis, and nor can they have a hip replacement as they are too early in the disease process. The use of PRP in OA of the hip has not been studied systematically and this study concisely collates all the available data in the use of PRP in Hip OA. This systematic review and meta-analysis aimed to assess intra-articular platelet-rich plasma as a therapeutic intervention for hip osteoarthritis, including the duration of efficacy, influence of dose and composition of PRP, and the incidence of adverse effects. We performed literature searches on the MEDLINE, EMBASE, CINHAL, WEB OF SCIENCE, COCHRANE and SCOPUS databases, and PRSIMA guidelines were followed. Data was pooled using random effects meta-analysis. We assessed quality of the included studies using the Methodological Index for Non-Randomised Studies (MINORS) instrument, with an additional assessment for Randomised Controlled Trials with the Revised Cochrane risk-of-bias tool for randomized trials (RoB 2). Eight studies were included in the analysis, with data from a total of 331 patients. PRP significantly reduced pain compared to baseline at multiple timepoints, with the greatest effect at 1–2mo follow-up. PRP only significantly improved function at the 1–2mo follow-up. A significantly larger reduction in pain was achieved with a single injection or PRP compared to multiple injections, a total injected dose of PRP <15mL compared to ≥15mL or using a leukocyte-poor PRP preparation compared to leukocyte-rich PRP. There were no lasting adverse effects. Low and moderate quality evidence suggests that PRP reduces pain and improves function at endpoint compared to baseline. Moderate quality evidence suggests a larger reduction in pain is achieved with a single injection of PRP compared to multiple injections, and low quality evidence attributes a larger reduction of pain with a total injected dose of PRP <15mL compared to ≥15mL or using leukocyte-poor PRP compared to leukocyte-rich PRP


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.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 97 - 97
1 Mar 2021
D'sa P Roberts G Williams M
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Abstract. Background. Recruitment of patients to participate in Randomised control trials (RCTs) is a challenging task, especially for trauma trials in which the identification and recruitment are time-limited. Multiple strategies have been tried to improve the participation of doctors and recruitment of patients. Aim. To study the effect of a trainee advocate (trainee Principal investigator-tPI) on influencing junior doctors to take part in trials and its effect on recruitment for a multicenter prospective hip fracture RCT. Methods. A retrospective study comparing the number of junior doctors participating in trials and patients recruited before and after the introduction of informal tPI role at UHW Cardiff. Results. The target recruitment set by the central trial unit was 9/month. Excluding the research team, there were 6 trainees actively recruiting in the before period (Feb’19-July’19) in comparison with 12 in the after period (Sept’19-Feb’20). TPI had a direct influence on 9 of the 11 trainees to get involved in the trials by guidance and nudging. There were 105 eligible patients of which 62 were recruited (59% of eligible pts, 115% of target) in the before period in comparison with 102 recruited (76% of eligible pts, 189% of target) out of the 135 eligible patients in the after period. The proportion of recruitment done by the research team to that of trainees was 79%:21% in the before period in comparison with 30%:70% in the after period further improving to 15%:85% in the last 3 months. Conclusion. TPI can work alongside the PI and research team to be a valuable link person coordinating and engaging local trainees to take part in trials. This may be particularly beneficial in hospitals where there is no dedicated research team. TPI role could be formalized for many trials and can be used as a leadership & management potential building experience for trainees. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project