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

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

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 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

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

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

Introduction. Tranexamic acid is an inhibitor of fibrinolysis that blocks the lysine-binding site of plasminogen to fibrin, and thereby decreases blood loss in patients undergoing surgery. Aims and objectives. A prospective, randomized, double-blind study was done on 100 patients undergoing primary cemented Unilateral Total Knee Arthroplasty to determine the effect of tranexamic acid on intra- and postoperative blood losses and on the transfusions requirements. Material and Methods. 100 patients undergoing unilateral cemented total knee Arthroplasty for osteoarthritis were enrolled for the study. All total knee replacement was done under combined spinal epidural anaesthesia with the use of tourniquet. 100 patients were randomized to tranexamic acid (15 mg/kg) given as a bolus intravenous injection or placebo (normal saline) given intravenously, 15 minutes before the release of tourniquiet. The blood loss (at removal of the drain 24 hours after the operation) and the number of blood transfusions required were recorded. The patients were screened for deep venous thrombosis with bilateral compression Ultrasonography using Colour Doppler imaging on the tenth postoperative day. The Hemoglobin level was measured preoperatively and on the 3rd postoperative day. The D-dimer levels were measured preoperatively and 24 hrs postoperatively. Results. Patients receiving tranexamic acid had a mean postoperative blood loss of 175 ml(range, 130–310ml) versus 330 ml (range, 210–460ml) (p value<0.05), and a total need for 3 blood transfusions versus 15. Only 3 out 50 patients in tranexamic acid group required blood transfusion whereas 12 out of 50 patients in the placebo group required transfusion. In the group receiving placebo the mean fall in hemoglobin was 2.1g/dl (range, 1.5–3.2) and in the group treated with tranexamic acid 1.3 g/dl (0.9–2) (p<0.05). At 24 hrs postoperatively, mean plasma D-dimer concentration in the Tranexamic group was half of that in the control group. No patient in either group had any evidence of deep vein thrombosis on bilateral compression Ultrasonography using Colour Doppler imaging done on the tenth postoperative day. Conclusion. Tranexamic acid 15 mg/kg given as a single bolus dose reduces blood loss, and transfusion requirements in unilateral primary cemented total kneearthroplasty without any increased risk of thrombus formation

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

A Morton's neuroma is a painful forefoot disorder characterised by plantar pain and toe paraesthesia. Many treatments have been tried including modification of shoe wear, injections and surgery. The results from different treatment modalities are extremely variable in the scientific literature. We reviewed 79 patients who presented with an ultrasound proven Morton's Neuromata at an average of 60 months following treatment in a patient blind randomised trial. 35 had surgery with resection of the Morton's Neuromata. We compared the results of the patients who had had a steroid injection and surgery, a steroid injection alone, a placebo injection and then surgery and a placebo injection alone. We looked at the requirement for further consultations, pain scores, activity restrictions, footwear restriction, overall satisfaction with their treatment and overall quality of life scores. We found no significant difference between the groups. Overall 80% of the surgical patients had a good or excellent result and 67% of the non- operatively managed patients had a good or excellent result. There was no difference in their quality of life scores. Previous studies have shown little benefit in steroid injections in the treatment of Morton's Neuromata. We conclude at the five year mark there is no significant differences between operating on Morton's Neuromata and treating them conservatively. Further research should focus on comparing operative vs conservative treatment in the short to medium term. In order to justify the risks and costs of surgery

Aims

The aim of this study was to investigate the association between additional rehabilitation at the weekend, and in-hospital mortality and complications in patients with hip fracture who underwent surgery.

The use of pulsed electromagnetic fields (PEMF) to stimulate bone growth has been recommended as an alternative to the surgical treatment of ununited scaphoid fractures, but has never been examined in acute fractures. We hypothesised that the use of PEMF in acute scaphoid fractures would accelerate the time to union by 30% in a randomised, double-blind, placebo-controlled, multicentre trial. A total of 53 patients in three different medical centres with a unilateral undisplaced acute scaphoid fracture were randomly assigned to receive either treatment with PEMF (n = 24) or a placebo (n = 29). The clinical and radiological outcomes were assessed at four, six, nine, 12, 24 and 52 weeks. A log-rank analysis showed that neither time to clinical and radiological union nor the functional outcome differed significantly between the groups. The clinical assessment of union indicated that at six weeks tenderness in the anatomic snuffbox (p = 0.03) as well as tenderness on longitudinal compression of the scaphoid (p = 0.008) differed significantly in favour of the placebo group. We conclude that stimulation of bone growth by PEMF has no additional value in the conservative treatment of acute scaphoid fractures

We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing

Objective:. To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation. Design:. A multicentre two arm patient and assessor double blind RCT. Setting:. Four UK centres (Edinburgh, Belfast, Liverpool, Bristol). Participants:. 62 skeletally mature adults undergoing distraction osteogenesis of 2.5–10cm at the proximal tibia. Patients with metabolic bone disorders were excluded. Interventions:. A metaphysial corticotomy was created and an Ilizarov frame applied. After 7 days, distraction was performed (0.75mm/day). After 1cm of distraction, an ‘ultrasound’ device was used for 20 minutes/day. Patients were randomised to either an active or a placebo (control) ultrasound device. Main outcome measures:. Primary outcome measure: time ready for removal of frame for both intension to treat (ITT) and per protocol (PP). Secondary outcomes: covariates affecting time to frame removal, return to weight bearing (>50% body weight), and compliance with device usage. Results:. 90% patients were managed as PP. There was no difference in time to frame removal for ITT (difference . in favour of control. group- 5.0days/cm, 95% CI −8.2 to18.21; p=0.23) or PP (difference . in favour of control. group-10.1days/cm, 95% CI −3.2 to 23.4; p=0.054). Smoking was the only covariate to increase frame removal time (hazard ratio 0.46, 95% CI 0.22 to 0.96; p=0.04). There was no difference in weight bearing between the two groups, after adjusting for distraction length, for the ITT cohort (p>0.5). The compliance was 78.8% & 81.6% in the PP group and 70.0 & 72.3% in the ITT group for active & control devices respectively. Conclusions:. Contrary to the existing literature, including NICE guidelines, this trial found no difference in bone healing between those who underwent low intensity pulsed ultrasound and those who did not. The trial was sufficiently powerful to demonstrate that smoking had a significantly deleterious effect on bone healing; approximately doubling the healing time

Aims

The purpose was to compare operative treatment with a volar plate and nonoperative treatment of displaced distal radius fractures in patients aged 65 years and over in a cost-effectiveness analysis.

In three consecutive years 462 patients over the age of 60 years presented at Waikato Hospital, Hamilton, New Zealand, with a fracture of the proximal femur. Within two years, 11 (2.4%) returned with a fracture of the contralateral femur. If the effectiveness of any form of treatment aiming at reducing the incidence of contralateral fracture were subjected to a trial, a sample size of 5000, randomly distributed equally between treatment and placebo groups, would be needed for the trial to have a power of 80% to detect a reduction

Introduction. The peri-operative analgesic management of patients having either Total Knee Replacement (TKR) or Unicompartmental Knee Replacement (UKR) is an area that continues to have prominence, driven in part by the desire to reduce hospital stay, while maintaining high patient satisfaction. This is particularly relevant in the current climate of healthcare cost savings. We evaluated the role of “top up” intra-articular local anaesthetic injection after identifying that an appreciable number of patients in the unit suffered “breakthrough pain” on the first post-op day, when the effects of local analgesia are wearing off. Method. 43 patients, who were scheduled to have a cemented Oxford UKR, were prospectively recruited and randomised. All patients had the same initial anaesthetic regime of general anaesthesia, femoral nerve block and intra-operative intra-articular infiltration of the cocktail. All patients had a 16G multi-holed epidural catheter placed intra-articularly prior to wound closure. Patients had the same operative technique, post operative rehabilitation and rescue analgesia. An independent observer recorded post-operative pain scores using a visual analogue score (1–10) every 6 hours and any rescue analgesia that was required. On the morning after surgery, 22 patients, (Group I), received 20 mls of 0.5% bupivicaine through the catheter whilst 21 patients, (Group II), had 20 mls of normal saline by the same observer, (who was blinded to the contents of the solution being injected), after which the catheter was removed. Results. When comparing these two groups there was no statistical difference found in their pain scores on the day of operation. However, patients in Group I had a significantly better pain score initially post top up and then at 6 hours (2.4 (0–8) vs 5.7 (2–9), Mann-Whitney p<0.001). This cohort of patients required less rescue analgesia (22% vs 75%, Mann-Whitney p<0.001). In addition, Group I had statistically significant higher patient satisfaction outcome scores after the infiltration, (p<0.001), with 16 reporting very good satisfaction in comparison to 1 in Group II. There were no complications in either group. Discussion. Our study has shown that injection of local anaesthesia via an intra-articular catheter does reduce pain scores when compared to placebo. This implies that this technique may have a role in providing optimal pain relief after UKR

Objectives

Bisphosphonates are widely used as first-line treatment for primary and secondary prevention of fragility fractures. Whilst they have proved effective in this role, there is growing concern over their long-term use, with much evidence linking bisphosphonate-related suppression of bone remodelling to an increased risk of atypical subtrochanteric fractures of the femur (AFFs). The objective of this article is to review this evidence, while presenting the current available strategies for the management of AFFs.

Exsanguination is the second most common cause of death in patients who suffer severe trauma. The management of haemodynamically unstable high-energy pelvic injuries remains controversial, as there are no universally accepted guidelines to direct surgeons on the ideal use of pelvic packing or early angio-embolisation. Additionally, the optimal resuscitation strategy, which prevents or halts the progression of the trauma-induced coagulopathy, remains unknown. Although early and aggressive use of blood products in these patients appears to improve survival, over-enthusiastic resuscitative measures may not be the safest strategy.

This paper provides an overview of the classification of pelvic injuries and the current evidence on best-practice management of high-energy pelvic fractures, including resuscitation, transfusion of blood components, monitoring of coagulopathy, and procedural interventions including pre-peritoneal pelvic packing, external fixation and angiographic embolisation.

Cite this article: Bone Joint J 2014; 96-B:1143–54.

Neurogenic heterotopic ossification (NHO) is a disorder of aberrant bone formation affecting one in five patients sustaining a spinal cord injury or traumatic brain injury. Ectopic bone forms around joints in characteristic patterns, causing pain and limiting movement especially around the hip and elbow. Clinical sequelae of neurogenic heterotopic ossification include urinary tract infection, pressure injuries, pneumonia and poor hygiene, making early diagnosis and treatment clinically compelling. However, diagnosis remains difficult with more investigation needed. Our pathophysiological understanding stems from mechanisms of basic bone formation enhanced by evidence of systemic influences from circulating humor factors and perhaps neurological ones. This increasing understanding guides our implementation of current prophylaxis and treatment including the use of non-steroidal anti-inflammatory drugs, bisphosphonates, radiation therapy and surgery and, importantly, should direct future, more effective ones.