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The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 3 | Pages 434 - 438
1 May 1991
Torholm C Broeng L Jorgensen P Bjerregaard P Josephsen L Jorgensen P Hagen K Knudsen J

In a double-blind, randomised study of thromboprophylaxis in patients undergoing total hip replacement, we compared a low-molecular-weight heparin with a placebo. Of the 120 patients enrolled, 112 completed the trial; 58 in the treatment group and 54 in the placebo group. Nine (16%) patients in the treatment group and 19 (35%) in the placebo group developed deep venous thrombosis, diagnosed by the 125I-fibrinogen uptake test (p < 0.02). Verification was obtained by phlebography in 86% of the patients. Prolonged surgery increased the risk of thrombosis in the placebo group but not in the treatment group (p < 0.05). There were significantly more cases of deep venous thrombosis in the placebo group during the first four postoperative days (p < 0.02). The groups did not differ with respect to peroperative and postoperative bleeding. Low-molecular-weight heparin offers safe and easily administered thromboprophylaxis in total hip replacement


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1408 - 1415
1 Dec 2024
Wall L Bunzli S Nelson E Hawke LJ Genie M Hinwood M Lang D Dowsey MM Clarke P Choong PF Balogh ZJ Lohmander LS Paolucci F

Aims

Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments.

Methods

This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model.


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


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 532 - 539
1 Jun 2024
Lei T Wang Y Li M Hua L

Aims. Intra-articular (IA) injection may be used when treating hip osteoarthritis (OA). Common injections include steroids, hyaluronic acid (HA), local anaesthetic, and platelet-rich plasma (PRP). Network meta-analysis allows for comparisons between two or more treatment groups and uses direct and indirect comparisons between interventions. This network meta-analysis aims to compare the efficacy of various IA injections used in the management of hip OA with a follow-up of up to six months. Methods. This systematic review and network meta-analysis used a Bayesian random-effects model to evaluate the direct and indirect comparisons among all treatment options. PubMed, Web of Science, Clinicaltrial.gov, EMBASE, MEDLINE, and the Cochrane Library were searched from inception to February 2023. Randomized controlled trials (RCTs) which evaluate the efficacy of HA, PRP, local anaesthetic, steroid, steroid+anaesthetic, HA+PRP, and physiological saline injection as a placebo, for patients with hip OA were included. Results. In this meta-analysis of 16 RCTs with a total of 1,735 participants, steroid injection was found to be significantly more effective than placebo injection on reported pain at three months, but no significant difference was observed at six months. Furthermore, steroid injection was considerably more effective than placebo injection for functional outcomes at three months, while the combination of HA+PRP injection was substantially more effective at six months. Conclusion. Evidence suggests that steroid injection is more effective than saline injection for the treatment of hip joint pain, and restoration of functional outcomes. Cite this article: Bone Joint J 2024;106-B(6):532–539


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 663 - 671
1 Jun 2022
Lewis E Merghani K Robertson I Mulford J Prentice B Mathew R Van Winden P Ogden K

Aims. Platelet-rich plasma (PRP) intra-articular injections may provide a simple and minimally invasive treatment for early-stage knee osteoarthritis (OA). This has led to an increase in its adoption as a treatment for knee OA, although there is uncertainty about its efficacy and benefit. We hypothesized that patients with early-stage symptomatic knee OA who receive multiple PRP injections will have better clinical outcomes than those receiving single PRP or placebo injections. Methods. A double-blinded, randomized placebo-controlled trial was performed with three groups receiving either placebo injections (Normal Saline), one PRP injection followed by two placebo injections, or three PRP injections. Each injection was given one week apart. Outcomes were prospectively collected prior to intervention and then at six weeks, three months, six months, and 12 months post-intervention. Primary outcome measures were Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQol five-dimension five-level index (EQ-5D-5L). Secondary outcomes included visual analogue scale for pain and patient subjective assessment of the injections. Results. A total of 102 patients were recruited. The follow-up period was 12 months, at intervals of six weeks, 12 weeks, six months, and 12 months. KOOS-Total significantly improved in all groups at these time intervals compared to pre-injection. There was an improvement in EQ-5D-5L index scores in saline and single injection groups, but not in the multiple injection group. Comparison of treatment groups showed no additional beneficial effect of single or multiple PRP injections above that displayed in the saline injection group. Subjective patient satisfaction and recommendation of treatment received demonstrated a similar pattern in all the groups. There was no indication of superiority of either single or multiple PRP injections compared to saline injections. Conclusion. There is no evidence that single or multiple PRP had any additional beneficial effect compared to saline injection up to 12 months, follow-up after treatment of early stage symptomatic OA of the knee. Cite this article: Bone Joint J 2022;104-B(6):663–671


The Bone & Joint Journal
Vol. 102-B, Issue 6 Supple A | Pages 10 - 18
1 Jun 2020
Ueyama H Kanemoto N Minoda Y Taniguchi Y Nakamura H

Aims. The aim of this study was to assess the effectiveness of perioperative essential amino acid (EAA) supplementation to prevent rectus femoris muscle atrophy and facilitate early recovery of function after total knee arthroplasty (TKA). Methods. The study involved 60 patients who underwent unilateral TKA for primary knee osteo-arthritis (OA). This was a double-blind, placebo-controlled, randomized control trial with patients randomly allocated to two groups, 30 patients each: the essential amino acid supplementation (9 g daily) and placebo (lactose powder, 9 g daily) groups. Supplementation and placebo were provided from one week before to two weeks after surgery. The area of the rectus femoris muscle were measured by ultrasound imaging one month before surgery and one, two, three, and four weeks postoperatively. The serum albumin level, a visual analogue knee pain score, and mobility were also measured at each time point. The time to recovery of activities of daily living (ADLs) was recorded. Postoperative nutrition and physiotherapy were identical in both groups. Results. The mean relative change from baseline was as follows for the amino acid group: 116% in rectus femoris muscle area (71% to 206%); 95% in serum albumin (80% to 115%) and 39% in VAS pain (0% to 100%) at four weeks after surgery. These values in the placebo group were: 97% in muscle area (68 to 155); 89% in serum albumin (71% to 100%) and 56% in VAS pain four weeks after surgery (0% to 100%). All changes were statistically significant (p < 0.05). The mean time to recovery of ADLs was shorter in the amino acid group compared with the placebo group (p = 0.005). Conclusion. Perioperative essential amino acid supplementation prevents rectus femoris muscle atrophy and accelerates early functional recovery after TKA. Cite this article: Bone Joint J 2020;102-B(6 Supple A):10–18


Bone & Joint 360
Vol. 12, Issue 2 | Pages 19 - 24
1 Apr 2023

The April 2023 Foot & Ankle Roundup. 360. looks at: Outcomes following a two-stage revision total ankle arthroplasty for periprosthetic joint infection; Temporary bridge plate fixation and joint motion after an unstable Lisfranc injury; Outcomes of fusion in type II os naviculare; Total ankle arthroplasty versus arthrodesis for end-stage ankle osteoarthritis; Normal saline for plantar fasciitis: placebo or therapeutic?; Distraction arthroplasty for ankle osteoarthritis: does it work?; Let there be movement: ankle arthroplasty after previous fusion; Morbidity and mortality after diabetic Charcot foot arthropathy


Bone & Joint 360
Vol. 12, Issue 3 | Pages 43 - 43
1 Jun 2023
Das A

This edition of Cochrane Corner looks at some of the work published by the Cochrane Collaboration, covering interventions for treating distal femur fractures in adults; ultrasound and shockwave therapy for acute fractures in adults; and local corticosteroid injection versus placebo for carpal tunnel syndrome


The Bone & Joint Journal
Vol. 101-B, Issue 2 | Pages 207 - 212
1 Feb 2019
Clavé A Gérard R Lacroix J Baynat C Danguy des Déserts M Gatineau F Mottier D

Aims. Cementless primary total hip arthroplasty (THA) is associated with risks of bleeding and thromboembolism. Anticoagulants are effective as venous thromboprophylaxis, but with an increased risk of bleeding. Tranexamic acid (TXA) is an efficient antifibrinolytic agent, but the mode and timing of its administration remain controversial. This study aimed to determine whether two intravenous (IV) TXA regimens (a three-hour two-dose (short-TXA) and 11-hour four-dose (long-TXA)) were more effective than placebo in reducing perioperative real blood loss (RBL, between baseline and day 3 postoperatively) in patients undergoing THA who receive rivaroxaban as thromboprophylaxis. The secondary aim was to assess the non-inferiority of the reduction of blood loss of the short protocol versus the long protocol. Patients and Methods. A multicentre, prospective, randomized, double-blind, placebo-controlled trial was undertaken involving 229 patients undergoing primary cementless THA using a posterior approach, whose extended rivaroxaban thromboprophylaxis started on the day of surgery. There were 98 male and 131 female patients, with a mean age of 65.5 years (32 to 91). The primary outcome, perioperative RBL, was evaluated at 72 hours postoperatively. The efficacy of short- and long-TXA protocols in the reduction of perioperative RBL was compared with a placebo group. Results. TXA significantly reduced perioperative blood loss compared with placebo (p < 0.001); the mean differences were 525.3 ml (short-TXA vs placebo) and 550.1 ml (long-TXA vs placebo). No venous or arterial thromboembolic complications were reported. The upper boundary of the 95% confidence interval, when comparing short and long protocols, was below the pre-specified margin of non-inferiority (p = 0.027). Conclusion. In patients undergoing primary cementless THA, using a posterior approach, who are treated with rivaroxaban for thromboembolic prophylaxis, short- and long-TXA IV protocols are significantly more effective than placebo in reducing perioperative RBL, without any thromboembolic complications. Non-inferiority of a short- versus a long-TXA protocol in reducing perioperative RBL was supported in a secondary analysis


Bone & Joint Open
Vol. 4, Issue 3 | Pages 158 - 167
10 Mar 2023
Landers S Hely R Hely A Harrison B Page RS Maister N Gwini SM Gill SD

Aims. This study investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure. Methods. A total of 59 participants with symptomatic Kellgren-Lawrence grade 2 knee OA were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests. Results. Overall, 58 participants provided questionnaire data at 12 months. No significant differences were found for the primary and secondary outcomes, with both groups improving following the procedure. At 12 months, KOOS pain scores improved by 41.3% and 29.4% in the intervention and control groups, respectively. No adverse events occurred. Subgroup analysis indicated that the complete embolization group had significantly better KOOS Sports and Recreation, KOOS Quality of Life, and Global Change scores than the control group; 76.5% of participants who received complete embolization reporting being moderately or much better compared to 37.9% of the control group. Conclusion. TAE might produce benefits above placebo, but only when complete embolization of all genicular arteries is performed. Further comparative studies are required before definitive conclusions regarding the effectiveness of TAE can be made. Level of evidence: I. Cite this article: Bone Jt Open 2023;4(3):158–167


Bone & Joint Open
Vol. 3, Issue 4 | Pages 340 - 347
22 Apr 2022
Winkler T Costa ML Ofir R Parolini O Geissler S Volk H Eder C

Aims. The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. Methods. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 10. 6. PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%. Conclusion. The HIPGEN study assesses the efficacy, safety, and tolerability of intramuscular PLX-PAD administration for the treatment of muscle injury following arthroplasty for hip fracture. It is the first phase III study to investigate the effect of an allogeneic cell therapy on improved mobilization after hip fracture, an aspect which is in sore need of addressing for the improvement in standard of care treatment for patients with FNF. Cite this article: Bone Jt Open 2022;3(4):340–347


Bone & Joint Research
Vol. 11, Issue 4 | Pages 239 - 250
20 Apr 2022
Stewart CC O’Hara NN Bzovsky S Bahney CS Sprague S Slobogean GP

Aims. Bone turnover markers (BTMs) follow distinct trends after fractures and limited evidence suggests differential levels in BTMs in patients with delayed healing. The effect of vitamin D, and other factors that influence BTMs and fracture healing, is important to elucidate the use of BTMs as surrogates of fracture healing. We sought to determine whether BTMs can be used as early markers of delayed fracture healing, and the effect of vitamin D on BTM response after fracture. Methods. A total of 102 participants aged 18 to 50 years (median 28 years (interquartile range 23 to 35)), receiving an intramedullary nail for a tibial or femoral shaft fracture, were enrolled in a randomized controlled trial comparing vitamin D. 3. supplementation to placebo. Serum C-terminal telopeptide of type I collagen (CTX; bone resorption marker) and N-terminal propeptide of type I procollagen (P1NP; bone formation marker) were measured at baseline, six weeks, and 12 weeks post-injury. Clinical and radiological fracture healing was assessed at three months. Results. CTX and P1NP concentrations peaked at six weeks in all groups. Elevated six-week CTX and P1NP were associated with radiological healing at 12 weeks post-injury (odds ratio (OR) 10.5; 95% confidence interval 2.71 to 53.5, p = 0.002). We found no association between CTX or P1NP and functional healing. Baseline serum 25(OH)D showed a weak inverse relationship with P1NP (p = 0.036) and CTX (p = 0.221) at 12 weeks, but we observed no association between vitamin D supplementation and either BTM. Conclusion. Given the association between six-week BTM concentrations and three-month radiological fracture healing, CTX and P1NP appear to be potential surrogate markers of fracture healing. Cite this article: Bone Joint Res 2022;11(4):239–250


The Bone & Joint Journal
Vol. 99-B, Issue 8 | Pages 1073 - 1079
1 Aug 2017
Pauzenberger L Domej MA Heuberer PR Hexel M Grieb A Laky B Blasl J Anderl W

Aims. The purpose of the present study was to evaluate the impact of intravenous tranexamic acid on the reduction of blood loss, transfusion rate, and early post-operative clinical outcome in total shoulder arthroplasty. Patients and Methods. A randomised, placebo-controlled trial which included 54 patients undergoing unilateral primary stemless anatomical or stemmed reverse total shoulder arthroplasty was undertaken. Patients received either 100 ml saline (placebo, n = 27), or 100 ml saline together with 1000 mg of tranexamic acid (TXA, n = 27) intravenously prior to skin incision and during wound closure. Peri-operative blood loss via an intra-articular drain was recorded and total blood loss was calculated. The post-operative transfusion rate was documented. Assessment of early clinical parameters included the visual analogue scale for pain (VAS), documentation of haematoma formation and adverse events. Results. Mean peri-operative blood drainage (placebo: 170 ml versus TXA: 50 ml, p = 0.001) and calculated mean total blood loss (placebo: 1248.2 ml versus TXA: 871.0 ml, p = 0.009) were significantly lower in the TXA group. No transfusions were necessary during the study period in either group. Mean VAS for pain significantly decreased from pre-operative (VAS 7) to the early post-operative period (VAS 1.7, p < 0.001). Significant differences regarding mean post-operative pain between placebo (VAS 2.0) and TXA (VAS 1.3) were detected (p = 0.05). The occurrence of haematomas was significantly more frequent in the placebo (59.3%, n = 16) than in the TXA group (25.9%, n = 6, p = 0.027). Whereas only mild haematomas developed in the TXA group, in the placebo group a total of 22.2% (n = 6) developed either moderate or severe haematomas. No adverse events associated with administration of TXA occurred. Conclusion. Intravenous administration of TXA successfully reduced mean peri-operative blood drainage, total estimated blood loss, pain during the first post-operative days, and haematoma formation in total shoulder arthroplasty. Cite this article: Bone Joint J 2017;99-B:1073–9


The Bone & Joint Journal
Vol. 100-B, Issue 7 | Pages 915 - 922
1 Jul 2018
Joice M Vasileiadis GI Amanatullah DF

Aims. The aim of this study was to assess the efficacy of non-selective and selective non-steroidal anti-inflammatory drugs (NSAIDs) in preventing heterotopic ossification (HO) after total hip arthroplasty (THA). Methods. A thorough and systematic literature search was conducted and 29 studies were found that met inclusion criteria. Data were extracted and statistical analysis was carried out generating forest plots. Results. Non-selective NSAIDs showed a significant decrease in the odds for forming HO after THA (odds ratio (OR) -1.35, confidence interval (CI) -1.83 to -0.86) when compared with placebo. Selective NSAIDs also showed a significant decrease in the odds for forming HO after THA when compared with placebo (OR -1.58, CI -2.41 to -0.75). When comparing non-selective NSAIDs with selective NSAIDs, there was no significant change in the odds for forming HO after THA (OR 0.22, CI -0.36 to 0.79). Conclusion. Our meta-analyses of all available data suggest that both non-selective and selective NSAIDs are effective HO prophylaxis and can be used routinely after THA for pain control as well as prevention of HO. Indomethacin may serve as the benchmark among non-selective NSAIDs and celecoxib among selective NSAIDs. There was no difference in the incidence of HO between non-selective and selective NSAIDs, allowing physicians to choose either based on the clinical scenario and patient-specific factors. Cite this article: Bone Joint J 2018;100-B:915–22


The Bone & Joint Journal
Vol. 95-B, Issue 4 | Pages 459 - 466
1 Apr 2013
Fisher WD Agnelli G George DJ Kakkar AK Lassen MR Mismetti P Mouret P Turpie AGG

There is currently limited information available on the benefits and risks of extended thromboprophylaxis after hip fracture surgery. SAVE-HIP3 was a randomised, double-blind study conducted to evaluate the efficacy and safety of extended thromboprophylaxis with the ultra-low molecular-weight heparin semuloparin compared with placebo in patients undergoing hip fracture surgery. After a seven- to ten-day open-label run-in phase with semuloparin (20 mg once daily subcutaneously, initiated post-operatively), patients were randomised to once-daily semuloparin (20 mg subcutaneously) or placebo for 19 to 23 additional days. The primary efficacy endpoint was a composite of any venous thromboembolism (VTE; any deep-vein thrombosis and non-fatal pulmonary embolism) or all-cause death until day 24 of the double-blind period. Safety parameters included major and clinically relevant non-major bleeding, laboratory data, and treatment-emergent adverse events (TEAEs). Extended thromboprophylaxis with semuloparin demonstrated a relative risk reduction of 79% in the rate of any VTE or all-cause death compared with placebo (3.9% vs 18.6%, respectively; odds ratio 0.18 (95% confidence interval 0.07 to 0.45), p < 0.001). Two patients in the semuloparin group and none in the placebo group experienced clinically relevant bleeding. TEAE rates were similar in both groups. In conclusion, the SAVE-HIP3 study results demonstrate that patients undergoing hip fracture surgery benefit from extended thromboprophylaxis. Cite this article: Bone Joint J 2013;95-B:459–66


Bone & Joint Open
Vol. 2, Issue 12 | Pages 1082 - 1088
1 Dec 2021
Hippalgaonkar K Chandak V Daultani D Mulpur P Eachempati KK Reddy AG

Aims. Single-shot adductor canal block (ACB) after total knee arthroplasty (TKA) for postoperative analgesia is a common modality. Patients can experience breakthrough pain when the effect of ACB wears off. Local anaesthetic infusion through an intra-articular catheter (IAC) can help manage breakthrough pain after TKA. We hypothesized that combined ACB with ropivacaine infusion through IAC is associated with better pain relief compared to ACB used alone. Methods. This study was a prospective double-blinded placebo-controlled randomized controlled trial to compare the efficacy of combined ACB+ IAC-ropivacaine infusion (study group, n = 68) versus single-shot ACB+ intra-articular normal saline placebo (control group, n = 66) after primary TKA. The primary outcome was assessment of pain, using the visual analogue scale (VAS) recorded at 6, 12, 24, and 48 hours after surgery. Secondary outcomes included active knee ROM 48 hours after surgery and additional requirement of analgesia for breakthrough pain. Results. The study group (mean visual analogue scale (VAS) pain score of 5.5 (SD 0.889)) experienced significant reduction in pain 12 hours after surgery compared to the control group (mean VAS 6.62 (SD 1.356); mean difference = 1.12, 95% confidence interval (CI) -1.46 to 0.67; p < 0.001), and pain scores on postoperative day (POD) 1 and POD-2 were lower in the study group compared to the control group (mean difference in VAS pain = 1.04 (-1.39 to -0.68, 95% CI, p < 0.001). Fewer patients in the study group (0 vs 3 in the control group) required additional analgesia for breakthrough pain, but this was not statistically significant. The study group had significantly increased active knee flexion (mean flexion 86.4° (SD 7.22°)), compared to the control group (mean 73.86° (SD 7.88°), mean difference = 12.54, 95% CI 9.97 to 15.1; p < 0.014). Conclusion. Combined ACB+ ropivacaine infusion via IAC is a safe, reproducible analgesic modality after primary TKA, with superior analgesia compared to ACB alone. Further large volume trials are warranted to generate evidence on clinical significance on analgesia after TKA. Cite this article: Bone Jt Open 2021;2(12):1082–1088


Objectives. Tranexamic acid (TXA) is an antifibrinolytic agent used as a blood-sparing technique in total knee arthroplasty (TKA), and is routinely administered by intravenous (IV) or intra-articular (IA) injection. Recently, a novel method of TXA administration, the combined IV and IA application of TXA, has been applied in TKA. However, the scientific evidence of combined administration of TXA in TKA is still meagre. This meta-analysis aimed to investigate the efficacy and safety of combined IV and IA TXA in patients undergoing TKA. Materials and Methods. A systematic search was carried out in PubMed, the Cochrane Clinical Trial Register (Issue12 2015), Embase, Web of Science and the Chinese Biomedical Database. Only randomised controlled trials (RCT) evaluating the efficacy and safety of combined use TXA in TKA were identified. Two authors independently identified the eligible studies, extracted data and assessed the methodological quality of included studies. Meta-analysis was conducted using Review Manager 5.3 software. Results. A total of ten RCTs (1143 patients) were included in this study. All the included studies were randomised and the quality of included studies still needed improvement. The results indicated that, compared with either placebo or the single-dose TXA (IV or IA) group, the combination of IV and IA TXA group had significantly less total blood loss, hidden blood loss, total drain output, a lower transfusion rate and a lower drop in haemoglobin level. There were no statistically significant differences in complications such as wound infection and deep vein thrombosis between the combination group and the placebo or single-dose TXA group. Conclusions. Compared with placebo or the single-dose TXA, the combined use of IV and IA TXA provided significantly better results with respect to all outcomes related to post-operative blood loss without increasing the risk of thromboembolic complications in TKA. Cite this article: Z. F. Yuan, H. Yin, W. P. Ma, D. L. Xing. The combined effect of administration of intravenous and topical tranexamic acid on blood loss and transfusion rate in total knee arthroplasty: combined tranexamic acid for TKA. Bone Joint Res 2016;5:353–361. DOI: 10.1302/2046-3758.58.BJR-2016-0001.R2


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 9 | Pages 1246 - 1252
1 Sep 2012
Penning LIF de Bie RA Walenkamp GHIM

A total of 159 patients (84 women and 75 men, mean age of 53 (20 to 87)) with subacromial impingement were randomised to treatment with subacromial injections using lidocaine with one of hyaluronic acid (51 patients), corticosteroid (53 patients) or placebo (55 patients). Patients were followed up for 26 weeks. The primary outcome was pain on a visual analogue score (VAS), and secondary outcomes included the Constant Murley score, shoulder pain score, functional mobility score, shoulder disability questionnaire and pain-specific disability score. The different outcome measures showed similar results. After three, six and 12 weeks corticosteroid injections were superior to hyaluronic acid injections and only at six weeks significantly better than placebo injections. The mean short-term reduction in pain on the VAS score at 12 weeks was 7% (. sd. 2.7; 97.5% confidence interval (CI) 0.207 to 1.55; p = 0.084) in the hyaluronic acid group, 28% (. sd. 2.8; 97.5% CI 1.86 to 3.65; p < 0.001) in the corticosteroid group and 23% (. sd. 3.23; 97.5% CI 1.25 to 3.26; p < 0.001) in the placebo group. At 26 weeks there was a reduction in pain in 63% (32 of 51) of patients in the hyaluronic acid group, 72% (38 of 53) of those in the corticosteroid group and 69% (38 of 55) of those in the placebo group. We were not able to show a convincing benefit from hyaluronic acid injections compared with corticosteroid or placebo injections. Corticosteroid injections produced a significant reduction in pain in the short term (three to 12 weeks), but in the long term the placebo injection produced the best results


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 12 | Pages 1613 - 1617
1 Dec 2006
Karunakar MA Sen A Bosse MJ Sims SH Goulet JA Kellam JF

Our study was designed to compare the effect of indometacin with that of a placebo in reducing the incidence of heterotopic ossification in a prospective, randomised trial. A total of 121 patients with displaced fractures of the acetabulum treated by operation through a Kocher-Langenbeck approach was randomised to receive either indometacin (75 mg) sustained release, or a placebo once daily for six weeks. The extent of heterotopic ossification was evaluated on plain radiographs three months after operation. Significant ossification of Brooker grade III to IV occurred in nine of 59 patients (15.2%) in the indometacin group and 12 of 62 (19.4%) receiving the placebo. We were unable to demonstrate a statistically significant reduction in the incidence of severe heterotopic ossification with the use of indometacin when compared with a placebo (p = 0.722). Based on these results we cannot recommend the routine use of indometacin for prophylaxis against heterotopic ossification after isolated fractures of the acetabulum


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1526 - 1532
1 Nov 2017
Tarride JE Hopkins RB Blackhouse G Burke N Bhandari M Johal H Guyatt GH Busse JW

Aims. This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial. Patients and Methods. Data for patients’ use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated. Results. With a cost per device of $3,995, the mean cost was significantly higher for patients treated with LIPUS versus placebo from a payer (mean increase = $3647, 95% confidence interval (CI) $3244 to $4070; p < 0.001) or a societal perspective (mean increase = $3425, 95% CI $1568 to $5283; p < 0.001). LIPUS did not provide a significant benefit in terms of QALYs gained (mean difference = 0.023 QALYs, 95% CI -0.035 to 0.069; p = 0.474). Incremental cost-effectiveness ratios of LIPUS compared with placebo were $155 433/QALY from a payer perspective and $146 006/QALY from a societal perspective. Conclusion. At the current price, LIPUS is not cost-effective for fresh tibial fractures managed with intramedullary nailing. Cite this article: Bone Joint J 2017;99-B:1526–32


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 2 | Pages 213 - 217
1 Feb 2005
Mundy GM Birtwistle SJ Power RA

We randomised 120 patients who were undergoing either primary total hip or knee arthroplasty to receive either ferrous sulphate or a placebo for three weeks after surgery. The level of haemoglobin and absolute reticulocyte count were measured at one and five days, and three and six weeks after operation. Ninety-nine patients (ferrous sulphate 50, placebo 49) completed the study. The two groups differed only in the treatment administered. Recovery of level of haemoglobin was similar at five days and three weeks and returned to 85% of the pre-operative level, irrespective of the treatment group. A small, albeit greater recovery in the level of haemoglobin was identified at six weeks in the ferrous sulphate group in both men (ferrous sulphate 5%, placebo 1.5%) and women (ferrous sulphate 6%, placebo 3%). The clinical significance of this is questionable and may be outweighed by the high incidence of reported side effects of oral iron and the cost of the medication. Administration of iron supplements after elective total hip or total knee arthroplasty does not appear to be worthwhile


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 3 | Pages 388 - 394
1 Mar 2009
Goel DP Buckley R deVries G Abelseth G Ni A Gray R

The incidence of deep-vein thrombosis and the need for thromboprophylaxis following isolated trauma below the knee is uncertain. We have investigated this with a prospective randomised double-blind controlled trial using low molecular weight heparin with saline injection as placebo in patients aged between 18 and 75 years who had sustained an isolated fracture below the knee which required operative fixation. All patients had surgery within 48 hours of injury and were randomised to receive either the placebo or low molecular weight heparin for 14 days, after which they underwent bilateral lower limb venography, interpreted by three independent radiologists. Further follow-up was undertaken at two, six, eight and 12 weeks. A total of 238 patients fulfilled all the inclusion criteria, with 127 in the low molecular weight heparin group and 111 in the placebo group, all of whom underwent bilateral venography. There was no statistically significant difference in the incidence of deep-vein thrombosis between those patients treated with low molecular weight heparin or the placebo (p = 0.22). The number of deep-vein thromboses in the two groups was 11 (8.7%) and 14 (12.6%), respectively. Age and the type of fracture were significantly associated with the rate of deep-vein thrombosis (p = 0.001 and p = 0.009, respectively) but gender, comorbidities and the body mass index were not. The overall incidence of deep-vein thrombosis in this series was 11%. There was no clinical or statistical significant reduction in the incidence of deep-vein thrombosis with the use of thromboprophylaxis. However, we accept that owing to a cessation of funding, recruitment to this trial had to be ended prior to establishing the necessary sample size. Our results cannot, therefore, categorically exclude the possibility that low molecular weight heparin treatment could be beneficial. We recommend a further multicentre trial be undertaken to resolve this matter


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1521 - 1526
1 Nov 2013
Kolk A Auw Yang KG Tamminga R van der Hoeven H

The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were randomly allocated to a treatment group who received low-dose rESWT (three sessions at an interval 10 to 14 days, 2000 pulses, 0.11 mJ/mm. 2. , 8 Hz) or to a placebo group, with a follow-up of six months. The patients and the treating orthopaedic surgeon, who were both blinded to the treatment, evaluated the results. A total of 44 patients were allocated to the rESWT group and 38 patients to the placebo group. A visual analogue scale (VAS) score for pain, a Constant–Murley (CMS) score and a simple shoulder test (SST) score significantly improved in both groups at three and six months compared with baseline (all p ≤ 0.012). The mean VAS was similar in both groups at three (p = 0.43) and six months (p = 0.262). Also, the mean CMS and SST scores were similar in both groups at six months (p = 0.815 and p = 0.834, respectively). It would thus seem that low-dose rESWT does not reduce pain or improve function in patients chronic rotator cuff tendinitis compared with placebo treatment. Cite this article: Bone Joint J 2013;95-B:1521–6


Bone & Joint Research
Vol. 6, Issue 7 | Pages 452 - 463
1 Jul 2017
Wang G Sui L Gai P Li G Qi X Jiang X

Objectives. Osteoporosis has become an increasing concern for older people as it may potentially lead to osteoporotic fractures. This study is designed to assess the efficacy and safety of ten therapies for post-menopausal women using network meta-analysis. Methods. We conducted a systematic search in several databases, including PubMed and Embase. A random-effects model was employed and results were assessed by the odds ratio (OR) and corresponding 95% confidence intervals (CI). Furthermore, with respect to each outcome, each intervention was ranked according to the surface under the cumulative ranking curve (SUCRA) value. Results. With respect to preventing new vertebral fractures (NVF), all ten drugs outperformed placebo, and etidronate proved to be the most effective treatment (OR 0.24, 95% CI 0.14 to 0.39). In addition, zoledronic acid and parathyroid hormone ranked higher compared with the other drugs. With respect to preventing clinical vertebral fractures (CVF), zoledronic acid proved to be the most effective drug (OR = 0.25, 95% CI 0.08 to 0.92), with denosumab as a desirable second option (OR = 0.48, 95% CI 0.22 to 0.96), when both were compared with placebo. As for adverse events (AE) and severe adverse events (SAE), no significant difference was observed. According to SUCRA, etidronate ranked first in preventing CVF; parathyroid hormone and zoledronic acid ranked highly in preventing NVF and CVF. Raloxifene was safe with a high rank in preventing AEs and SAEs though performed unsatisfactorily in efficacy. Conclusions. This study suggests that, taking efficacy and safety into account, parathyroid hormone and zoledronic acid had the highest probability of satisfactory performance in preventing osteoporotic fractures. Cite this article: G. Wang, L. Sui, P. Gai, G. Li, X. Qi, X. Jiang. The efficacy and safety of vertebral fracture prevention therapies in post-menopausal osteoporosis treatment: Which therapies work best? a network meta-analysis. Bone Joint Res 2017;6:452–463. DOI: 10.1302/2046-3758.67.BJR-2016-0292.R1


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 747 - 753
1 Jun 2016
Tengberg PT Foss NB Palm H Kallemose T Troelsen A

Aims. We chose unstable extra-capsular hip fractures as our study group because these types of fractures suffer the largest blood loss. We hypothesised that tranexamic acid (TXA) would reduce total blood loss (TBL) in extra-capsular fractures of the hip. . Patients and Methods. A single-centre placebo-controlled double-blinded randomised clinical trial was performed to test the hypothesis on patients undergoing surgery for extra-capsular hip fractures. For reasons outside the control of the investigators, the trial was stopped before reaching the 120 included patients as planned in the protocol. . Results. In all 72 patients (51 women, 21 men; 33 patients in the TXA group, 39 in the placebo group) were included in the final analysis, with a significant mean reduction of 570.8 ml (p = 0.029) in TBL from 2100.4 ml (standard deviation (. sd). = 1152.6) in the placebo group to 1529.6 ml (. sd. = 1012.7) in the TXA group. . The 90-day mortality was 27.2% (n = 9) in the TXA group and 10.2% (n = 4) in the placebo group (p = 0.07). We were not able to ascertain a reliable cause of death in these patients. . Discussion. TXA significantly reduced TBL in extra-capsular hip fractures, but concerns regarding its safety in this patient group must be investigated further before the use of TXA can be recommended. Take home message: We present a randomised clinical trial that is unique in the literature. We evaluate the effect of TXA in very homogenous population - extra-capsular fractures operated with short intramedullary nails. Cite this article: Bone Joint J 2016;98-B:747–53


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 924 - 932
1 Jul 2015
Lee MC Ha C Elmallah RK Cherian JJ Cho JJ Kim TW Bin S Mont MA

The aim of this study was to assess the effect of injecting genetically engineered chondrocytes expressing transforming growth factor beta 1 (TGF-β1) into the knees of patients with osteoarthritis. We assessed the resultant function, pain and quality of life. . A total of 54 patients (20 men, 34 women) who had a mean age of 58 years (50 to 66) were blinded and randomised (1:1) to receive a single injection of the active treatment or a placebo. We assessed post-treatment function, pain severity, physical function, quality of life and the incidence of treatment-associated adverse events. Patients were followed at four, 12 and 24 weeks after injection. At final follow-up the treatment group had a significantly greater improvement in the mean International Knee Documentation Committee score than the placebo group (16 points; -18 to 49, vs 8 points; -4 to 37, respectively; p = 0.03). The treatment group also had a significantly improved mean visual analogue score at final follow-up (-25; -85 to 34, vs -11 points; -51 to 25, respectively; p = 0.032). Both cohorts showed an improvement in Western Ontario and McMaster Osteoarthritis Index and Knee Injury and Osteoarthritis Outcome Scores, but these differences were not statistically significant. One patient had an anaphylactic reaction to the preservation medium, but recovered within 24 hours. All other adverse events were localised and resolved without further action. . This technique may result in improved clinical outcomes, with the aim of slowing the degenerative process, leading to improvements in pain and function. However, imaging and direct observational studies are needed to verify cartilage regeneration. Nevertheless, this study provided a sufficient basis to proceed to further clinical testing. Cite this article: Bone Joint J 2015;97-B:924–32


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 905 - 910
1 Jul 2015
Hsu C Lin P Kuo F Wang J

Tranexamic acid (TXA), an inhibitor of fibrinolysis, reduces blood loss after total knee arthroplasty. However, its effect on minimally invasive total hip arthroplasty (THA) is not clear. We performed a prospective, randomised double-blind study to evaluate the effect of two intravenous injections of TXA on blood loss in patients undergoing minimally invasive THA. In total, 60 patients (35 women and 25 men with a mean age of 58.1 years; 17 to 84) who underwent unilateral minimally invasive uncemented THA were randomly divided into the study group (30 patients, 20 women and ten men with a mean age of 56.5 years; 17 to 79) that received two intravenous injections 1 g of TXA pre- and post-operatively (TXA group), and a placebo group (30 patients, 15 women and 15 men with a mean age of 59.5 years; 23 to 84). We compared the peri-operative blood loss of the two groups. Actual blood loss was calculated from the maximum reduction in the level of haemoglobin. All patients were followed clinically for the presence of venous thromboembolism. The TXA group had a lower mean intra-operative blood loss of 441 ml (150 to 800) versus 615 ml (50 to 1580) in the placebo (p = 0.044), lower mean post-operative blood loss (285 ml (120 to 570) versus 392 ml (126 to 660) (p = 0.002), lower mean total blood loss (1070 ml (688 to 1478) versus 1337 ml (495 to 2238) (p = 0.004) and lower requirement for transfusion (p = 0.021). No patients in either group had symptoms of venous thromboembolism or wound complications. . This prospective, randomised controlled study showed that a regimen of two intravenous injections of 1 g TXA is effective for blood conservation after minimally invasive THA. Cite this article: Bone Joint J 2015;97-B:905–10


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 442 - 448
1 Mar 2021
Nikolaou VS Masouros P Floros T Chronopoulos E Skertsou M Babis GC

Aims. The aim of this study was to investigate the hypothesis that a single dose of tranexamic acid (TXA) would reduce blood loss and transfusion rates in elderly patients undergoing surgery for a subcapital or intertrochanteric (IT) fracture of the hip. Methods. In this single-centre, randomized controlled trial, elderly patients undergoing surgery for a hip fracture, either hemiarthroplasty for a subcapital fracture or intramedullary nailing for an IT fracture, were screened for inclusion. Patients were randomly allocated to a study group using a sealed envelope. The TXA group consisted of 77 patients, (35 with a subcapital fracture and 42 with an IT fracture), and the control group consisted of 88 patients (29 with a subcapital fracture and 59 with an IT fracture). One dose of 15 mg/kg of intravenous (IV) TXA diluted in 100 ml normal saline (NS,) or one dose of IV placebo 100 ml NS were administered before the incision was made. The haemoglobin (Hb) concentration was measured before surgery and daily until the fourth postoperative day. The primary outcomes were the total blood loss and the rate of transfusion from the time of surgery to the fourth postoperative day. Results. Homogeneity with respect to baseline characteristics was ensured between groups. The mean total blood loss was significantly lower in patients who received TXA (902.4 ml (-279.9 to 2,156.9) vs 1,226.3 ml (-269.7 to 3,429.7); p = 0.003), while the likelihood of requiring a transfusion of at least one unit of red blood cells was reduced by 22%. Subgroup analysis showed that these differences were larger in patients who had an IT fracture compared with those who had a subcapital fracture. Conclusion. Elderly patients who undergo intramedullary nailing for an IT fracture can benefit from a single dose of 15 mg/kg TXA before the onset of surgery. A similar tendency was identified in patients undergoing hemiarthroplasty for a subcapital fracture but not to a statistically significant level. Cite this article: Bone Joint J 2021;103-B(3):442–448


The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1138 - 1145
1 Sep 2018
Soreide E Murad MH Denbeigh JM Lewallen EA Dudakovic A Nordsletten L van Wijnen AJ Kakar S

Aims. Dupuytren’s contracture is a benign, myoproliferative condition affecting the palmar fascia that results in progressive contractures of the fingers. Despite increased knowledge of the cellular and connective tissue changes involved, neither a cure nor an optimum form of treatment exists. The aim of this systematic review was to summarize the best available evidence on the management of this condition. Materials and Methods. A comprehensive database search for randomized controlled trials (RCTs) was performed until August 2017. We studied RCTs comparing open fasciectomy with percutaneous needle aponeurotomy (PNA), collagenase clostridium histolyticum (CCH) with placebo, and CCH with PNA, in addition to adjuvant treatments aiming to improve the outcome of open fasciectomy. A total of 20 studies, involving 1584 patients, were included. Results. PNA tended to provide higher patient satisfaction with fewer adverse events, but had a higher rate of recurrence compared with limited fasciectomy. Although efficacious, treatment with CCH had notable recurrence rates and a high rate of transient adverse events. Recent comparative studies have shown no difference in clinical outcome between patients treated with PNA and those treated with CCH. Conclusion. Currently there remains limited evidence to guide the management of patients with Dupuytren’s contracture. Cite this article: Bone Joint J 2018;100-B:1138–45


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 7 | Pages 932 - 936
1 Jul 2012
Lin P Hsu C Huang C Chen W Wang J

Tranexamic acid (TEA), an inhibitor of fibrinolysis, reduces blood loss after routine total knee replacement (TKR). However, controversy persists regarding the dosage and timing of administration of this drug during surgery. We performed a prospective randomised controlled study to examine the optimum blood-saving effect of TEA in minimally invasive TKR. We randomly assigned 151 patients who underwent unilateral minimally invasive TKR to three groups: 1) a placebo group (50 patients); 2) a one-dose TEA group (52 patients), who received one injection of TEA (10 mg/kg) intra-operatively on deflation of the tourniquet; and 3) a two-dose TEA group (49 patients), who received two injections of TEA (10 mg/kg) given pre-operatively and intra-operatively. Total blood loss was calculated from the maximum loss of haemoglobin. All patients were followed clinically for the presence of venous thromboembolism (VTE). The mean total blood loss was significantly higher in the placebo group than in the other two groups (1222 ml (845 to 2043) versus 1035 ml (397 to 1934) and 986 ml (542 to 1811), respectively (both p < 0.0001)). The mean blood loss was not significantly different between the one- and two-TEA groups (p = 0.148). The mean transfusion rate was higher in the placebo group than in the other two groups (22% versus 3.8% (p = 0.006) and 6.1% (p = 0.041), respectively) and there was no statistically significant difference in the mean transfusion rate between the one- and two-TEA groups (p = 0.672). Only one patient, in the two-dose group, had a radiologically confirmed deep venous thrombosis. Our prospective randomised controlled study showed that one intra-operative injection of TEA is effective for blood conservation after minimally invasive TKR


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 2 | Pages 251 - 256
1 Feb 2011
Yokote R Matsubara M Hirasawa N Hagio S Ishii K Takata C

Prophylaxis against venous thromboembolism after elective total hip replacement is routinely recommended. Our preference has been to use mechanical prophylaxis without anticoagulant drugs. A randomised controlled trial was performed to evaluate whether the incidence of post-operative venous thromboembolism was reduced by using pharmacological anticoagulation with either fondaparinux or enoxaparin in addition to our prophylactic mechanical regimen. A total of 255 Japanese patients who underwent primary unilateral cementless total hip replacement were randomly assigned to one of three postoperative regimens, namely injection of placebo (saline), fondaparinux or enoxaparin. There were 85 patients in each group. All also received the same mechanical prophylaxis during and after the operation, regardless of their assigned group. The primary measurement of efficacy was the presence of a venous thromboembolic event by day 11, defined as deep-vein thrombosis detected by ultrasonography, documented symptomatic deep-vein thrombosis or documented symptomatic pulmonary embolism. The duration of follow-up was 12 weeks. The rate of venous thromboembolism was 7.2% with the placebo, 7.1% with fondaparinux and 6.0% with enoxaparin (p = 0.95 for the comparison of all three groups). Our study confirmed the effectiveness and safety of mechanical thromboprophylaxis without the use of anticoagulant drugs after total hip replacement in Japanese patients


The Bone & Joint Journal
Vol. 99-B, Issue 4 | Pages 494 - 502
1 Apr 2017
Simpson AHRW Keenan G Nayagam S Atkins RM Marsh D Clement ND

Aims. The aim of this double-blind prospective randomised controlled trial was to assess whether low intensity pulsed ultrasound (LIPUS) accelerated or enhanced the rate of bone healing in adult patients undergoing distraction osteogenesis. Patients and Methods. A total of 62 adult patients undergoing limb lengthening or bone transport by distraction osteogenesis were randomised to treatment with either an active (n = 32) or a placebo (n = 30) ultrasound device. A standardised corticotomy was performed in the proximal tibial metaphysis and a circular Ilizarov frame was used in all patients. The rate of distraction was also standardised. The primary outcome measure was the time to removal of the frame after adjusting for the length of distraction in days/cm for both the per protocol (PP) and the intention-to-treat (ITT) groups. The assessor was blinded to the form of treatment. A secondary outcome was to identify covariates affecting the time to removal of the frame. Results. There was no difference in the time to removal of the frame between the PP (difference in favour of the control group was 10.1 days/cm, 95% confidence interval (CI) -3.2 to 23.4, p = 0.054) or ITT (difference 5.0 days/cm, 95% CI -8.2 to 18.21, p = 0.226) groups. The smoking status was the only covariate which increased the time to removal of the frame (hazard ratio 0.47, 95% CI 0.22 to 0.97, p = 0.042). Conclusion. LIPUS does not influence the rate of bone healing in patients who undergo distraction osteogenesis. Smoking may influence bone healing. . Cite this article: Bone Joint J 2017;99-B:494–502


Bone & Joint Research
Vol. 4, Issue 5 | Pages 84 - 92
1 May 2015
Hamamura K Nishimura A Iino T Takigawa S Sudo A Yokota H

Objectives. Salubrinal is a synthetic agent that elevates phosphorylation of eukaryotic translation initiation factor 2 alpha (eIF2α) and alleviates stress to the endoplasmic reticulum. Previously, we reported that in chondrocytes, Salubrinal attenuates expression and activity of matrix metalloproteinase 13 (MMP13) through downregulating nuclear factor kappa B (NFκB) signalling. We herein examine whether Salubrinal prevents the degradation of articular cartilage in a mouse model of osteoarthritis (OA). Methods. OA was surgically induced in the left knee of female mice. Animal groups included age-matched sham control, OA placebo, and OA treated with Salubrinal or Guanabenz. Three weeks after the induction of OA, immunoblotting was performed for NFκB p65 and p-NFκB p65. At three and six weeks, the femora and tibiae were isolated and the sagittal sections were stained with Safranin O. Results. Salubrinal suppressed the progression of OA by downregulating p-NFκB p65 and MMP13. Although Guanabenz elevates the phosphorylation level of eIF2α, it did not suppress the progression of OA. Conclusions. Administration of Salubrinal has chondroprotective effects in arthritic joints. Salubrinal can be considered as a potential therapeutic agent for alleviating symptoms of OA. Cite this article: Bone Joint Res 2015;4:84–92


The Bone & Joint Journal
Vol. 99-B, Issue 6 | Pages 799 - 805
1 Jun 2017
Ketola S Lehtinen JT Arnala I

Aims. Rotator cuff tendinopathy has a multifactorial origin. Rejecting the mechanistic theory has also led to abandoning operative treatment at initial presentation in the first line. Physiotherapy exercise programmes are the accepted first line treatment. The aim of this study was to assess the long-term additional benefits of subacromial decompression in the treatment of rotator cuff tendinopathy. Patients and Methods. This randomised controlled trial of 140 patients (52 men, 88 women, mean age 47.1 years; 18 to 60) with rotator cuff tendinopathy extended previous work up to a maximum of 13 years. The patients were randomised into two treatment groups: arthroscopic acromioplasty and a supervised exercise treatment and a similar supervised exercise treatment alone. Self-reported pain on a visual analogue scale (VAS) was the primary outcome measure. Secondary measures were disability, working ability, pain at night, Shoulder Disability Questionnaire score and the number of painful days during the three months preceding the final assessment. Results. A total of 90 patients (64%) returned questionnaires at a mean 12 years after randomisation. On an intention-to-treat basis, both treatment groups reached statistically significant improvement compared with the initial VAS for pain, but there was no significant difference between groups. The same was true in the secondary outcome measures. Due to group changes, the results were also analysed per protocol: operated or not. No significant differences between the groups were found. Conclusion. The natural history of rotator cuff tendinopathy probably plays a significant role in the results in the long-term. Even though the patients who underwent operative treatment had a stronger belief in recovery, which is likely to be surgical and the effect of placebo, the exercise group obtained similar results. In the future, an optimum exercise regime should be searched for, as the most clinically and cost-effective conservative treatment for rotator cuff tendinopathy. Cite this article: Bone Joint J 2017;99-B:799–805


The Journal of Bone & Joint Surgery British Volume
Vol. 76-B, Issue 1 | Pages 99 - 102
1 Jan 1994
Rubinstein E Findler G Amit P Shaked I

We investigated the efficacy of a single dose of 1 g of cephazolin in reducing postoperative infections in patients undergoing 'clean' operations on the lumbar spine. In a double-blind, randomised, trial there were 21 wound or urinary infections in the 71 patients who received placebo and nine in the 70 who received cephazolin (p < 0.05). Nine of the placebo patients (12.7%) developed wound infections (complicated by bacteraemia in two) compared with three (4.3%) in the cephazolin group (p = 0.07). Hospital stay was longer for infected patients than for non-infected patients (p < 0.05). Cephazolin-resistant pathogens were isolated more frequently from patients who received cephazolin than from those who received placebo


Bone & Joint 360
Vol. 13, Issue 5 | Pages 51 - 52
1 Oct 2024
Marson BA

The Cochrane Collaboration has produced three new reviews relevant to bone and joint surgery since the publication of the last Cochrane Corner. These are relevant to a wide range of musculoskeletal specialists, and include reviews in lateral elbow pain, osteoarthritis of the big toe joint, and cervical spine injury in paediatric trauma patients.


Bone & Joint 360
Vol. 13, Issue 4 | Pages 23 - 26
2 Aug 2024

The August 2024 Wrist & Hand Roundup360 looks at: Methotrexate shows potential in reducing pain for hand osteoarthritis with synovitis; Circumferential casting versus plaster splinting in adult distal radius fractures: the CAST study findings; Surgery shows superior long-term success for Dupuytren contracture compared to needle fasciotomy and collagenase injection; Evolving trends in surgical management of wrist arthritis: a decade-long national analysis; Mid-term outcomes of three commonly used surgical reconstructions for scapholunate instability; SLAC and SNAC: what is the evidence for treatment?; Steroids for trapeziometacarpal osteoarthritis?; When is it safe to return to driving after distal radius fracture fixation? A prospective study.


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1005 - 1015
1 Aug 2014
Alshryda S Sukeik M Sarda P Blenkinsopp J Haddad FS Mason JM

Intravenous tranexamic acid (TXA) has been shown to be effective in reducing blood loss and the need for transfusion after joint replacement. Recently, there has been interest in applying it topically before the closure of surgical wounds. This has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systemic absorption and, consequently, concerns about possible side-effects. We conducted a systematic review and meta-analysis which included 14 randomised controlled trials (11 in knee replacement, two in hip replacement and one in both) which investigated the effect of topical TXA on blood loss and rates of transfusion. Topical TXA significantly reduced the rate of blood transfusion (total knee replacement: risk ratio (RR) 4.51; 95% confidence interval (CI): 3.02 to 6.72; p < 0.001 (nine trials, I. 2 . = 0%); total hip replacement: RR 2.56; 95% CI: 1.32 to 4.97, p = 0.004 (one trial)). The rate of thromboembolic events with topical TXA were similar to those found with a placebo. Indirect comparison of placebo-controlled trials of topical and intravenous TXA indicates that topical administration is superior to the intravenous route. In conclusion, topical TXA is an effective and safe method of reducing the need for blood transfusion after total knee and hip replacement. Further research is required to find its optimum dose for topical use. Cite this article: Bone Joint J 2014;96-B:1005–15


Bone & Joint Open
Vol. 3, Issue 11 | Pages 898 - 906
15 Nov 2022
Dakin H Rombach I Dritsaki M Gray A Ball C Lamb SE Nanchahal J

Aims

To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective.

Methods

We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded.


Bone & Joint 360
Vol. 12, Issue 5 | Pages 36 - 39
1 Oct 2023

The October 2023 Trauma Roundup360 looks at: Intramedullary nailing versus sliding hip screw in trochanteric fracture management: the INSITE randomized clinical trial; Five-year outcomes for patients with a displaced fracture of the distal tibia; Direct anterior versus anterolateral approach in hip joint hemiarthroplasty; Proximal humerus fractures: treat them all nonoperatively?; Tranexamic acid administration by prehospital personnel; Locked plating versus nailing for proximal tibia fractures: a multicentre randomized controlled trial; A retrospective review of the rate of septic knee arthritis after retrograde femoral nailing for traumatic femoral fractures at a single academic institution.


Bone & Joint 360
Vol. 13, Issue 1 | Pages 41 - 43
1 Feb 2024

The February 2024 Research Roundup360 looks at: If you use a surgical helmet, you should seal your gown-glove interface; The use of iodophor-impregnated drapes in patients with iodine-related allergies: a case series and review of the literature; Location of the ovaries in children and efficacy of gonadal shielding in hip and pelvis radiography; Prehospital tranexamic acid administration does not improve outcomes in severe trauma patients; Silver-coated distal femur megaprosthesis in chronic infections with severe bone loss: a multicentre case series.


Bone & Joint 360
Vol. 13, Issue 1 | Pages 13 - 16
1 Feb 2024

The February 2024 Hip & Pelvis Roundup360 looks at: Trial of vancomycin and cefazolin as surgical prophylaxis in arthroplasty; Is preoperative posterior femoral neck tilt a risk factor for fixation failure? Cemented versus uncemented hemiarthroplasty for displaced intracapsular fractures of the hip; Periprosthetic fractures in larger hydroxyapatite-coated stems: are collared stems a better alternative for total hip arthroplasty?; Postoperative periprosthetic fracture following hip arthroplasty with a polished taper slip versus composite beam stem; Is oral tranexamic acid as good as intravenous?; Stem design and the risk of early periprosthetic femur fractures following THA in elderly patients; Does powered femoral broaching compromise patient safety in total hip arthroplasty?


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1520 - 1525
1 Nov 2017
Haines N Kempton LB Seymour RB Bosse MJ Churchill C Hand K Hsu JR Keil D Kellam J Rozario N Sims S Karunakar MA

Aims. To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. 3. orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D. 3. . Cite this article: Bone Joint J 2017;99-B:1520–5


Bone & Joint 360
Vol. 12, Issue 5 | Pages 49 - 50
1 Oct 2023
Marson BA

This edition of Cochrane Corner looks at some of the work published by the Cochrane Collaboration, covering pharmacological interventions for the prevention of bleeding in people undergoing definitive fixation or joint replacement for hip, pelvic, and long bone fractures; interventions for reducing red blood cell transfusion in adults undergoing hip fracture surgery: an overview of systematic reviews; and pharmacological treatments for low back pain in adults: an overview of Cochrane Reviews


The Bone & Joint Journal
Vol. 95-B, Issue 4 | Pages 504 - 509
1 Apr 2013
Hutchison AM Pallister I Evans RM Bodger O Topliss CJ Williams P Beard DJ

We conducted a randomised controlled trial to determine whether active intense pulsed light (IPL) is an effective treatment for patients with chronic mid-body Achilles tendinopathy. A total of 47 patients were randomly assigned to three weekly therapeutic or placebo IPL treatments. The primary outcome measure was the Victorian Institute of Sport Assessment – Achilles (VISA-A) score. Secondary outcomes were a visual analogue scale for pain (VAS) and the Lower Extremity Functional Scale (LEFS). Outcomes were recorded at baseline, six weeks and 12 weeks following treatment. Ultrasound assessment of the thickness of the tendon and neovascularisation were also recorded before and after treatment. . There was no significant difference between the groups for any of the outcome scores or ultrasound measurements by 12 weeks, showing no measurable benefit from treatment with IPL in patients with Achilles tendinopathy. Cite this article: Bone Joint J 2013;95-B:504–9


Bone & Joint 360
Vol. 12, Issue 5 | Pages 21 - 23
1 Oct 2023

The October 2023 Sports Roundup360 looks at: Extensor mechanism disruption in the treatment of dislocated and multiligament knee injuries; Treatment of knee osteoarthritis with injection of stem cells; Corticosteroid injection plus exercise or exercise alone as adjuvants for patients with plantar fasciitis?; Generalized joint hypermobility and a second ACL injury?; The VISA-A ((sedentary) questionnaire for Achilles tendinopathy?.


The Bone & Joint Journal
Vol. 97-B, Issue 6 | Pages 734 - 740
1 Jun 2015
den Hartog YM Mathijssen NMC van Dasselaar NT Langendijk PNJ Vehmeijer SBW

Only limited data are available regarding the infiltration of local anaesthetic for total hip arthroplasty (THA), and no studies were performed for THA using the anterior approach. . In this prospective, randomised placebo-controlled study we investigated the effect of both standard and reverse infiltration of local anaesthetic in combination with the anterior approach for THA. The primary endpoint was the mean numeric rating score for pain four hours post-operatively. In addition, we recorded the length of hospital stay, the operating time, the destination of the patient at discharge, the use of pain medication, the occurrence of side effects and pain scores at various times post-operatively. Between November 2012 and January 2014, 75 patients were included in the study. They were randomised into three groups: standard infiltration of local anaesthetic, reversed infiltration of local anaesthetic, and placebo. There was no difference in mean numeric rating score for pain four hours post-operatively (p = 0.87). There were significantly more side effects at one and eight hours post-operatively in the placebo group (p = 0.02; p = 0.03), but this did not influence the mobilisation of the patients. There were no differences in all other outcomes between the groups. We found no clinically relevant effect when the infiltration of local anaesthetic with ropivacaine and epinephrine was used in a multimodal pain protocol for THA using the anterior approach. Cite this article: Bone Joint J 2015; 97-B:734–40


Bone & Joint 360
Vol. 13, Issue 5 | Pages 34 - 37
1 Oct 2024

The October 2024 Shoulder & Elbow Roundup360 looks at: Proximal humeral fractures with vascular compromise; Outcomes and challenges of revision arthroscopic rotator cuff repair: a systematic review; Evaluating treatment effectiveness for lateral elbow tendinopathy: a systematic review and network meta-analysis; Tendon transfer techniques for irreparable subscapularis tears: a comparative review; Impact of subscapularis repair in reverse shoulder arthroplasty; Isolated subscapularis tears strongly linked to shoulder pseudoparesis; Nexel and Coonrad-Morrey total elbow arthroplasties show comparable revision rates in New Zealand study; 3D MRI matches 3D CT in assessing bone loss and shoulder morphology in dislocation cases.


Bone & Joint 360
Vol. 13, Issue 1 | Pages 26 - 29
1 Feb 2024

The February 2024 Shoulder & Elbow Roundup360 looks at: Does indomethacin prevent heterotopic ossification following elbow fracture fixation?; Arthroscopic capsular shift in atraumatic shoulder joint instability; Ultrasound-guided lavage with corticosteroid injection versus sham; Combined surgical and exercise-based interventions following primary traumatic anterior shoulder dislocation: a systematic review and meta-analysis; Are vascularized fibula autografts a long-lasting reconstruction after intercalary resection of the humerus for primary bone tumours?; Anatomical versus reverse total shoulder arthroplasty with limited forward elevation; Tension band or plate fixation for simple displaced olecranon fractures?; Is long-term follow-up and monitoring in shoulder and elbow arthroplasty needed?


Bone & Joint 360
Vol. 11, Issue 6 | Pages 31 - 34
1 Dec 2022

The December 2022 Shoulder & Elbow Roundup360 looks at: Biceps tenotomy versus soft-tissue tenodesis in females aged 60 years and older with rotator cuff tears; Resistance training combined with corticosteroid injections or tendon needling in patients with lateral elbow tendinopathy; Two-year functional outcomes of completely displaced midshaft clavicle fractures in adolescents; Patients who undergo rotator cuff repair can safely return to driving at two weeks postoperatively; Are two plates better than one? A systematic review of dual plating for acute midshaft clavicle fractures; Treatment of acute distal biceps tendon ruptures; Rotator cuff tendinopathy: disability associated with depression rather than pathology severity; Coonrad-Morrey total elbow arthroplasty implications in young patients with post-traumatic sequelae.