Greater trochanteric pain syndrome is a painful condition characterised by pain around the greater trochanter usually affecting middle-aged women. The majority of patients will improve with conservative management such as physiotherapy and non-steroidal anti-inflammatory drugs (NSAIDs); however, if this fails then more invasive treatments including corticosteroids and surgery may be required. Platelet-rich plasma (PRP) is an autologous blood product, which has a higher concentration of growth factors postulated to provide enhanced healing and anti-inflammatory properties. The Hip Injections PRP Vs Placebo (HIPPO) trial aims to assess the ability of ultrasound-guided PRP injections to improve symptoms and function in patients with GTPS. 64 patients were enrolled and randomised to either the PRP or placebo (normal saline) treatment arm. Two patients decided to drop out of the trial. Clinical outcomes in both groups were evaluated and compared using the International Hip Outcome Tool-12 (iHOT12), Visual Analogue Scale (VAS) of pain, the modified Harris Hip Score (mHHS) and the presence or absence of complications at 3 and six months. The level of significance was set at p<0.05. Both groups received physiotherapy after the injections. The mean age was 57.5. There were 6 males and 56 females with M:F ratio of 1:9.3. Both groups were similar in terms of demography and preoperative scores. The iHOT12 score improved from 28.23 to 45.42 at three-months and decreased slightly to 42.44 at six-months in the Placebo group. The iHOT12 in the PRP group improved from 35.51 to 44.47 at three-months and decreased to 39.78 at six-months. Both groups showed improved VAS and mHHS at three-months compared to the baseline with no statistically significant difference between the two groups (p >0.05). The scores decreased at six-months however remained above the baseline. No complications were reported. Gender and age had no effect on outcomes. Both groups similarly improved from baseline. Physiotherapy can be considered as an important factor in patients' treatment. Further research should be conducted to investigate the role of physiotherapy in the treatment of GTPS

Tennis elbow (lateral epicondylitis) is a common upper limb condition, possibly resulting from angiofibroblastic degeneration. Conservative treatment comprises corticosteroid injections, rest and splints, however, occasionally surgery is necessary. Recent data comparing Botulinum Toxin Type A (BTX-A) (Botox®, Allergan Inc, Irvine, CA) with surgery suggested BTX-A is effective in treating resistant tennis elbow by providing temporary, reversible paralysis of affected muscle, thereby alleviating tensile forces and allowing tissue healing. This double-blind, randomised, controlled trial compared BTX-A with placebo in 40 patients with chronic tennis elbow (> 6 months). Recruited patients were randomised to 50U BTX-A+2mL normal saline or 2mL normal saline (placebo). Injections were administered 5cm distal to the maximal area of lateral epicondyle tenderness. Quality of life (SF-12), pain (visual analogue scale) and grip strength (Jamar dynamometer) were assessed pre- and 3 months post-injection in both affected and non-affected arms. Following BTX-A treatment patients had average 19% improvement in grip strength in the affected arm compared to average 2% for placebo, however, this difference did not reach statistical significance (p=0.08, 95% CI −2.31, 35.64). No difference between the groups was seen for the unaffected arm (BTX-A 4% improvement, placebo 1% improvement). Both groups showed similar improvements in pain assessment and also in quality of life. BTX-A treated-patients demonstrated improved grip strength in the affected arm compared to placebo, however this difference was not statistically significant

To evaluate the effects of 6 and 18 months of abaloparatide (ABL) compared with placebo (PBO) on bone mineral density (BMD) in the acetabular regions of postmenopausal women with osteoporosis (OP). Acetabular bone loss, as may occur in OP, increases risk of acetabular fragility fractures. a. In total hip arthroplasty (THA), low acetabular BMD adversely affects primary stability, osseointegration, and migration of acetabular cups. c. ABL is an osteoanabolic agent for the treatment of men and postmenopausal women with OP at high risk for fracture. Effects of ABL on acetabular BMD are unknown. Hip DXA scans were obtained at baseline, 6, and 18 months from a random subgroup of postmenopausal women (aged 49–86 y) from the phase 3 ACTIVE trial randomized to either ABL 80 µg/d or PBO (n=250/group). Anatomical landmarks were identified in each DXA scan to virtually place a hemispherical shell model of an acetabular cup and define regions of interest corresponding to DeLee & Charnley zones 1 (R1), 2 (R2), and 3 (R3). BMD changes compared to baseline were calculated for each zone. Statistical P values were based on a repeated mixed measures model. BMD in all zones were similar at baseline in the ABL and PBO groups. BMD significantly increased in the ABL group at 6 and 18 months compared with PBO (all P<0.0001 vs PBO). BMD in the PBO group was relatively stable over time. ABL treatment resulted in rapid and progressive increases in BMD of all 3 acetabular zones. Increasing acetabular BMD has the potential to improve acetabular strength, which may reduce risk of acetabular fragility fractures. In bone health optimization prior to THA, increased acetabular BMD via ABL may provide better primary stability and longevity of acetabular cups in postmenopausal women with OP

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

Purpose: The objective of this study was to compare the safety and efficacy of 1 × 6 mL intra-articular administration of hylan G-F 20 with placebo. Methods: In this prospective, multicenter, randomized, double-blind study, patients diagnosed with knee OA were randomized to one 6-mL injection of hylan G-F 20 or saline. The primary efficacy analysis (WOMAC A) was performed on the intent-to-treat population and was based on a repeated-measures model over the 26 weeks of the study. Results: 253 patients were randomized to hylan G-F 20 (n=124) or placebo (n=129). Mean age was 63 years (42–84), BMI 29.4 (19.5–52.4 kg/m2), 71% were female, and all had primary knee OA of Kellgren Lawrence grade 2 (45%) or 3 (55%). Patients in the hylan G-F 20 group experienced a mean change from baseline in their WOMAC A Likert pain score (0–4 scale) over 26 weeks (primary efficacy criteria) of −0.84, which was statistically significantly different from the change reported in the placebo group (−0.69, p=0.047). Statistically significant differences favoring hylan G-F 20 were also reported for most of the secondary efficacy criteria: WOMAC A1 (estimate Odds Ratio over 26 weeks placebo/hylan G-F 20, 0.64, p=0.013), patient global assessment (0.69, p=0.029), and clinical observer global assessment (0.71, p=0.041); WOMAC B and C changes were not statistically significant between groups. The OMERACT-OARSI responder analysis indicated that 59% of the patients were responders in the hylan G-F 20 group versus 51% in placebo group (0.66, p=0.059). There was no statistically significant difference in the use of rescue medication (acetaminophen) between the 2 groups. Discussion and Conclusion: This double-blind placebo-controlled study showed one injection of hylan G-F 20 provided symptomatic relief lasting up to 6 months in patients with knee OA; it avoids the need for multiple injections

Introduction of new surgical intervention need assessment of the true results by eliminating cognitive dissonance and the placebo effect. Significant time must elapse since the procedure to derive conclusions. With the initial gratifying results of Endoscopic Foraminoplasty a retrospective analysis of the data was performed to identify if the outcome was accurate and not a placebo effect. Early postoperative Data (6 weeks and 6 months) derived from questionnaires on 91 patients with Endoscopic Foraminoplasty (April 1997 and November 1998), which included the Oswestry Disability Scale and a Visual Analogue Pain Scale was compared with the data at 2 years (late). A t-test was used to assess the difference between the Oswestry Disability scores from the two questionnaires and a Wilcoxon Signed Rank test for the Visual Analogue Pain Scale. No significant difference between the Visual Analogue Pain Scores at 6 weeks to 6 months and 2 years post-operation was noted. There was however, a marginal improvement (p= 0.05) in Oswestry Index over two years period. The initial outcome of Endoscopic Laser Foraminoplasty was sustained or improved at the end of two years and was not a placebo effect

Introduction: Viscosupplementation is an effective treatment for patients suffering from knee osteoarthritis (OA). Most available products use 3 or 5 injection regimens. The objective of this study was to compare the safety and efficacy of a single 6 mL intra-articular administration of hylan G-F 20 with placebo. Methods: In this prospective, multicenter, randomized, double-blind study, patients diagnosed with knee OA were randomized to one 6-mL injection of hylan G-F 20 or saline. The primary efficacy analysis (WOMAC A) was performed on the intent-to-treat population and was based on a repeated-measures model over the 26 weeks of the study. The incidence of adverse events (AEs) was collected over the study duration. Results: 253 patients were randomized to hylan G-F 20 (n=124) or placebo (n=129). Mean age was 63 years (42–84), BMI 29.4 (19.5–52.4 kg/m2), 71% were female, and all had primary knee OA of Kellgren Lawrence grade 2 (45%) or 3 (55%). Patients in the hylan G-F 20 group experienced a mean change from baseline in their WOMAC A Likert pain score (0–4 scale) over 26 weeks (primary efficacy criteria) of −0.84, which was statistically significantly different from the change reported in the placebo group (−0.69, p=0.047). Statistically significant differences favoring hylan G-F 20 were also reported for most of the secondary efficacy criteria: WOMAC A1 (estimate Odds Ratio over 26 weeks placebo/hylan G-F 20, 0.64, p=0.013), patient global assessment (0.69, p=0.029), and clinical observer global assessment (0.71, p=0.041); WOMAC B and C changes were not statistically significant between groups. There was no statistically significant difference in the use of rescue medication between the 2 groups. There were no serious AEs related to treatment. In the target knee, injection-related AEs occurred in 4.9% and 3.1% of patients for hylan G-F 20 and placebo, respectively, and treatment-related AEs occurred in 3.3% and 0.8% of patients, respectively. All target knee AEs were local pain, with or without joint swelling or effusion, and were of mild or moderate intensity. Conclusion: This double-blind placebo-controlled study showed one injection of hylan G-F 20, possibly repeated 6 months later, was safe and provided symptomatic relief lasting up to 6 months in patients with knee OA

Introduction Intra-Discal Electrothermal Therapy (IDET) has been proposed as a treatment for chronic discogenic low back pain. Reports from prospective outcome studies demonstrate statistically significant improvements, but to date there are no published randomized controlled trials assessing efficacy versus a placebo group. Methods Ethical committee approval was obtained prior to the study. Patients with chronic low back pain who failed to improve with conservative therapy were considered. Inclusion criteria included the presence of one or two level symptomatic disc degeneration with posterior or postero-lateral annular tears as determined by provocative CT/discography. Patients were excluded if there was > 50% loss of disc height or previous back surgery. Fifty-seven patients were randomized with a 2:1 (IDET: Placebo) ratio, 38 to the active IDET arm and 19 to the sham procedure (placebo). In all cases the IDET catheter was positioned under sedation to cover at least 70% of the annular tear defined by the CT/discogram. An independent technician connected the catheter to the generator and either delivered electrothermal energy (active group) or did not (sham group). Both surgeon and patients were blinded to the treatment. Patients followed a standard post-procedural rehabilitation programme. Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), SF-36 questionnaire, Zung Depression Index (ZDI) and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and six months. Successful outcome was defined as: no neurological deficit resulting from the procedure, improvement in LBOS of > 7 points, improvements in SF-36 subsets (pain/disability, physical functioning and bodily pain). Two subjects withdrew from the study (both IDET). Baseline demographic data, employment and workers’ compensation status, sitting tolerance, initial LBOS, ODI, SF-36, ZDI and MSPQ were similar for both groups. Results No neurological deficits occurred as a result of either procedure. No subject in either treatment arm showed improvement of > 7 points in LBOS or specified domains of the SF-36. Mean ODI was 41.4 at baseline and 39.7 at six months for the IDET group compared to 40.7 at baseline and 41.5 at six months for the placebo group. There was no significant change in ZDI or MSPQ scores for either group. No subject in either treatment arm met criteria for successful outcome. Further analysis showed no significant change in outcome measures in either group at six months. Conclusions This study demonstrates no significant benefit from IDET over placebo

Introduction: Intra-Discal Electrothermal Therapy (IDET) has been proposed as a treatment for chronic discogenic low back pain. Reports from prospective outcome studies demonstrate statistically significant improvements, but to date there are no published randomized controlled trials assessing efficacy versus a placebo group. Methods: Ethical committee approval was obtained prior to the study. Patients with chronic low back pain who failed to improve with conservative therapy were considered for the study. Inclusion criteria included the presence of one or two level symptomatic disc degeneration with posterior or posterolateral annular tears as determined by provocative CT/discography. Patients were excluded if there was > 50% loss of disc height or previous back surgery. Fifty-seven patients were randomized with a 2:1 (IDET: Placebo) ratio, 38 to the active IDET arm and 19 to the sham procedure (placebo). In all cases the IDET catheter was positioned under sedation to cover at least 70% of the annular tear defined by the CT/ discogram. An independent technician connected the catheter to the generator and either delivered electrothermal energy (active group) or did not (sham group). Both surgeon and patient were blinded to the treatment. Patients followed a standard post-procedural rehabilitation programme. Outcome Measures: Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), SF-36 questionnaire, Zung Depression Index (ZDI) and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: No neurological deficit resulting from the procedure, improvement in LBOS of > 7 points, improvements in SF-36 subsets (pain / disability, physical functioning and bodily pain). Results: Two subjects withdrew from the study (both IDET). Baseline demographic data, employment and worker’s compensation status, sitting tolerance, initial LBOS, ODI, SF-36, ZDI and MSPQ were similar for both groups. No neurological deficits occurred as a result of either procedure. No subject in either treatment arm showed improvement of > 7 points in LBOS or specified domains of the SF-36. Mean ODI was 41.4 at baseline and 39.7 at 6 months for the IDET group compared to 40.7 at baseline and 41.5 at six months for the Placebo group. There was no significant change in ZDI or MSPQ scores for either group. Discussion: No subject in either treatment arm met criteria for successful outcome. Further analysis showed no significant change in outcome measures in either group at six months. This study demonstrates no significant benefit from IDET over placebo

INTRODUCTION: Intra-Discal Electrothermal Therapy (IDET) has been proposed as a treatment for chronic discogenic low back pain. Reports from prospective outcome studies demonstrate statistically significant improvements, but to date there are no published randomised controlled trials assessing efficacy versus a placebo group. METHODS: Ethical committee approval was obtained prior to the study. Patients with chronic low back pain who failed to improve with conservative therapy were considered for the study. Inclusion criteria included the presence of one or two level symptomatic disc degeneration with posterior or posterolateral annular tears as determined by provocative CT/discography. Patients were excluded if there was > 50% loss of disc height or previous back surgery. Fifty-seven patients were randomised with a 2:1 (IDET: Placebo) ratio, 38 to the active IDET arm and 19 to the sham procedure (placebo). In all cases the IDET catheter was positioned under sedation to cover at least 70% of the annular tear defined by the CT/ discogram. An independent technician connected the catheter to the generator and either delivered electrothermal energy (active group) or did not (sham group). Both surgeon and patient were blinded to the treatment. Patients followed a standard post-procedural rehabilitation programme. OUTCOME MEASURES: Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), SF-36 questionnaire, Zung Depression Index (ZDI) and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and six months. Successful outcome was defined as: No neurological deficit resulting from the procedure, improvement in LBOS of > 7 points, improvements in SF-36 subsets (pain/disability, physical functioning and bodily pain). RESULTS: Two subjects withdrew from the study (both IDET). Baseline demographic data, employment and worker’s compensation status, sitting tolerance, initial LBOS, ODI, SF-36, ZDI and MSPQ were similar for both groups. No neurological deficits occurred as a result of either procedure. No subject in either treatment arm showed improvement of > 7 points in LBOS or specified domains of the SF-36. Mean ODI was 41.4 at baseline and 39.7 at six months for the IDET group compared to 40.7 at baseline and 41.5 at six months for the Placebo group. There was no significant change in ZDI or MSPQ scores for either group. DISCUSSION: No subject in either treatment arm met criteria for successful outcome. Further analysis showed no significant change in outcome measures in either group at six months. This study demonstrates no significant benefit from IDET over placebo

This study was designed to prospectively evaluate the efficacy of indomethacin as prophylaxis for heterotopic ossification (HO) after operatively treated acetabular fractures. An IRB approved, prospective double blind placebo controlled clinical trial was performed at two level I trauma centres to evaluate the efficacy of indomethacin as prophylaxis for heterotopic ossification after the operative treatment of acetabular fractures. Between January 1, 1999 and May 31, 2003, two hundred and thirty-two patients with acetabular fractures were treated operatively through a posterior approach. Patients with the following conditions were excluded from study participation: age < 18, spinal cord injury, ankylosing spondylitis, burns, gastrointestinal bleed, Glasgow coma scale < 12, cerebrovascular accident, pregnancy and use of other non-steroidal anti-inflammatory drugs. One hundred and fifty-seven eligible patients were identified and one hundred and twenty-five patients were enrolled in the clinical trial. One hundred and seven patients have sufficient follow up to be included in data analysis. All patients underwent operative stabilization of their ace-tabular fractures by either a combined anterior and posterior approach or an isolated posterior Kocher-Lan-genbock approach. After fixation and prior to wound closure, any necrotic gluteus minimus muscle was debrided to viable muscle. Sixty-one patients were randomized to the placebo group and forty-six patients to the indomethacin treatment group. Indomethacin 75 mg SR and the placebo were administered to the patients by the investigational drug pharmacy in a blinded fashion. The medication was taken once daily for six weeks. Patient compliance was measured by obtaining indomethacin serum levels at the first postoperative visit (2 weeks). The extent of HO was evaluated on plain radiographs (AP and Judet) at three months postoperatively. The radiographs were scored for the presence of HO using the Brooker classification as modified by Moed. The data were analyzed two ways: 1) by excluding patients with protocol deviations and 2) by using an intent-to-treat model, where all enrolled subjects with 3 month Brooker scores were included in the analysis, regardless of whether they withdrew or were dropped from the study for clinical reasons. The sample size was estimated to produce a statistical power of 80% to detect a difference of 15% between the two treatment groups with alpha = .05. There were no significant differences with regards to age, sex, body mass index (BMI), ISS (injury severity score) and complications between the two treatment groups. The overall incidence of HO (Brooker I-IV) was 52.8% and the overall incidence of significant HO (Brooker III/IV) was 19.6%. There were four patients with Brooker IV HO. There was no significant difference between the treatment groups in the incidence of HO according to Brooker class (p=0.23). Significant HO (Brooker grades III-IV) occurred in 8 cases (17%) in the indomethacin group and 13 cases (21%) in the placebo group. There was no significant difference in the presence of moderate to severe HO (Brooker III/IV) between the two treatment groups (Fisher’s exact test p=0.81). Eighty-two of one hundred and seven patients enrolled completed the protocol. Twenty-five patients did not complete the treatment protocol for the following reasons: stopped medication due to side effects, did not receive medication at discharge, lost medication, or medication stopped by another physician who did not understand the purpose of the study. Nine patients (8.4%) did not receive the full medication course, sixteen patients (15%) were dropped or withdrew from the study for adverse events or gastrointestinal symptoms. Twelve patients dropped or withdrew from the indomethacin group and three from the placebo group. Forty percent of patients in the indomethacin group had non-detectable serum levels at two weeks. Complications identified in the indomethacin treatment group included deep venous thrombosis (5), wound infection (2), nonunion (1), gastrointestinal bleed (1) and perforated ulcer (1). Complications identified in the placebo group included deep venous thrombosis (6) and wound infection (2). In this prospective randomized study, a placebo provided as effective prophylaxis against the development of heterotopic ossification as indomethacin. More patients withdrew from the indomethacin group for gastrointestinal side effects or adverse events than in the placebo group. Patient compliance with indomethacin was poor with 40% of patients having no detectable indomethacin serum level. Serious gastrointestinal complications (gastrointestinal bleed and perforated ulcer) occurred in two patients treated with indomethacin

Aim: To estimate the prevalence of iron deficiency in patients undergoing primary total hip (THR) or knee (TKR) replacement surgery and to test the clinical effectiveness of routinely prescribing iron supplements to all anæmic patients after THR and TKR. Method: This was designed as a randomised, doubleblind, placebo-controlled trial. Serum ferritin was measured in 230 consecutive patients admitted for primary THR or TKR. Seventy-two patients were entered into the randomised arm of the trial, 35 were randomised to the treatment group, and 37 to the placebo group. Patients meeting the inclusion criteria after primary THR or TKR were randomised to receive six week’s treatment with either ferrous sulphate (200mg) or an identical gelatin placebo, three times daily. The serum ferritin level and the change in hæmoglobin were measured between five and seven days post-operatively and each patient attended for an out-patient review at six weeks after the surgery. Results: The study achieved a statistical power of 80%. Serum ferritin was abnormally low in 15 of 230 patients (6.5%). Hæmoglobin in the group of patients receiving ferrous sulphate increased by a mean of 0.31 g/dL more than the group receiving the placebo (95% confidence interval −0.17 −0.79 g/dL). This difference was not statistically significant (p=0.18). Conclusions: We found that iron deficiency was uncommon in patients who had undergone primary THR or TKR. The routine prescription of oral iron salts to all anæmic patients after these procedures had no clinical benefit

Introduction: Intra-Discal Electrothermal Therapy (IDET) has been proposed as a treatment for chronic discogenic low back pain. Reports from prospective outcome studies demonstrate statistically significant improvements, but there are no published randomized controlled trials assessing efficacy against a placebo group. Methods: Ethical committee approval was obtained prior to the study. Patients with chronic low back pain who failed conservative treatment were considered for the study. Inclusion criteria included one or two level symptomatic internal disc disruption as determined by provocative CT/discography. Patients were excluded if there was > 50% loss of disc height or had had previous back surgery. Fifty-seven patients were randomized with a 2:1 (IDET: Placebo) ratio, 38 to the active IDET arm and 19 to the sham (placebo). The IDET catheter was positioned under sedation to cover at least 75% of the annular tear as defined by the CT/discogram. An independent technician connected the catheter to the generator and either delivered electrothermal energy (active group) or did not (sham group). Surgeon, patient and independent outcome assessor were all blinded. All patients followed a standard rehabilitation programme. Outcome Measures: Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), SF-36 questionnaire, Zung Depression Index (ZDI) and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: No neurological deficit resulting from the procedure, improvement > 7 points in LBOS, improvements > 7 points in SF-36 subsets (pain / disability, physical functioning and bodily pain). Results: Two subjects withdrew from the study (both IDET). Baseline demographic data, employment and worker’s compensation status, sitting tolerance, initial LBOS, ODI, SF-36, ZDI and MSPQ were similar for both groups. No neurological deficits occurred as a result of either procedure. No subject in either treatment arm showed improvement of > 7 points in LBOS or the specified domains of the SF-36. Mean ODI was 41.4 at baseline and 39.7 at 6 months for the IDET group compared to 40.7 at baseline and 41.5 at six months for the Placebo group. There was no significant change in ZDI or MSPQ scores for either group. Discussion: No subject in either treatment arm met criteria for successful outcome. There was no significant change in outcome measures in either group at six months. This study demonstrates no significant benefit from IDET over placebo

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.

Purpose: To determine the effectiveness of rESWT for chronic plantar heel pain. Materials and methods: 70 patients were enrolled and randomly assigned to either active or placebo treatment. 2000 shock waves per session and 3 sessions were applied, interval of 2 weeks. The primary efficacy criteria were subjective outcome on Visual Analogue Scale (VAS) and Roles- and Maudsley-Score. The primary study endpoint was 12 weeks. Nonparametric procedures have been used for teststatistical analyses. In addition to P-values, results have been presented by means of Mann-Whitney estimators as nonparametric effect sizes and their one-sided 97.5% confidence intervals as required by the ICH E9 Guideline ( Exact Wilcoxon-Mann-Whitney test, ï ¡ = 0.025 one-sided). Results: 62 patients could be examined 12 weeks after rESWT. Drop out rate 12%. Significant decrease in pain sensation could be found in the active group (p< 0, 001). The VAS decreased from 7.1 (+/− 1,6) to 3.6 (+/− 2,3). Placebo group showed slight improvement from 6.7 (+/−1,8) to 5.9 (+/− 2,2). The effect size (Mann-Whitney) denotes a large superiority of the rESWT group (MW = 0.72). The lower bound of the asymptotic one-sided 97.5% confidence interval denotes superiority of the test group (LB-CI = 0.58). The results scored on Roles- and Maudsley-Score showed similar improvement. Only minor side effects as petechial bleeding and swelling were detected. Conclusion: The radial shock wave therapy is effective and save in treatment of chronic heel pain

Intra-Discal Electrothermal Therapy (IDET) has been proposed as a treatment for chronic discogenic low back pain. Reports from prospective outcome studies demonstrate statistically significant improvements, but to date there are no published randomized controlled trials assessing efficacy when compared to a placebo group. Ethical Committee approval was obtained prior to the study. Patients with chronic low back pain who failed to improve with conservative therapy were considered for the study. Subjects had one or two level symptomatic disc degeneration as determined by provocative CT/discography. Patients were excluded if there was > 50% loss of disc height or previous back surgery. Fifty-seven patients were randomized with a 2:1 (IDET: Placebo) ratio, 38 to the active IDET arm and 19 to the sham procedure (placebo). In all cases the IDET catheter was positioned under sedation to cover at least 70% of the annular tear defined by the CT/discogram. An independent technician connected the catheter to the generator and either delivered electrothermal energy (active group) or did not (sham group). Both surgeon and patient were blinded to the treatment. Patients followed a standard rehabilitation programme. Low Back outcome score (LBOS), Oswestry Disability Index (ODI), SF-36 questionnaire, Zung Depression Index (ZDI) and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: no neurological deficit resulting from the procedure, improvement in LBOS of > 7 points, improvements in SF-36 subsets (pain/disability, physical functioning and bodily pain). Two subjects withdrew (both IDET). Baseline demographic data, employment and worker’s compensation status, sitting tolerance, initial LBOS, ODI, SF-36, ZDI and MSPQ were similar for both groups. No neurological deficits occurred as a result of either procedure. No subject in either treatment arm showed improvement of > 7 points in LBOS or specified domains of the SF-36. Mean ODI was 41.4 at baseline and 39.7 at 6 months for the IDET group compared to 40.7 at baseline and 41.5 at six months for the Placebo group. There was no significant change in ZDI or MSPQ for either group. No subject in either treatment arm met criteria for successful outcome. Further analysis showed no significant change in outcome measures in either group at six months. In conclusion, this study demonstrates no significant benefit from IDET over placebo

The potential importance of bone morphogenic proteins (BMPs) to improve fracture healing is of great interest to orthopaedic surgeons. Although the complex mechanisms leading from the presence of local BMP (either endogenous or exogenous) to form bone is increasingly understood, however most appropriate time to administer exogenous BMP has yet to be elucidated. The purpose of this study was to investigate when BMP may be administered to a fracture arena in order to best improve fracture healing. Forty mice were randomised into 4 groups; (group I) control, treated at day 0 with placebo; (groups II, III and IV) treated with BMP at days 0, 4 and 8, respectively. All animals underwent a previously validated surgical procedure involving the creation of an open femoral fracture which is stabilised using a 4 pin external fixator. Thirty microlitres of bovine serum albumin (BSA) alone was used in group I, and the other groups (II, III and IV) were treated with a combination of the BSA and 2.5 microgrames of rhBMP-2. The BSA and rhBMP were injected through a lateral approach immediately after operation, or at 4, or 8 days postoperatively. At days 0, 8, 16 and 22, sequential radiographs were taken using a digital x-ray machine and at day 22 all animals were sacrificed. Both femora were harvested and assessed biomechanically in 3-point bending prior to fixation for histological evaluation. All data were analysed using Mann-Whitney U tests (SPSS, Version 9, Chicago, Illinois) and differences were considered significant at p < 0.05. X-ray analysis indicated that healing of fractures treated with BMP at day 0(group II) or day 4(group III) was significantly greater than that at both days 16 and 22 (p < 0.05) than those animals in placebo (group I) and BMP day 8(group V) treatment groups. Although the administration of BMP at day 4 seemed to cause more bone formation than treatment at day 0, no significant difference were observed. There were no differences between group IV and group I. Biomechanically, group III exhibited ultimate load values closest to the contralateral unoperated femora followed by group II, then IV and finally the control group I. Significant differences (p < 0.05) were observed between the control animals (group I) and both groups II and III. Qualitative histology suggested that at 22 days after surgery, only groups II and III had healed with woven bone. Group I and group IV had considerable amounts of fibrous tissue and cartilage at the fracture gap. This study suggests that a single percutaneous injection of BMP has a positive effect on fracture healing in this model, when prescribed between the time of injury (day 0) and 4 days. Data suggests that the most effective timing of delivery of BMP may not be at the time of surgery but actually in the early healing phase. The day 4 time point in the mouse model is likely to equate to that of 7–10 days in larger animals or humans. This suggests that current human treatment practices may require further investigation in order to elucidate the most appropriate time of delivery for these important proteins. This work may negate the current requirements for carrier products and large doses of these expensive drugs

Introduction and Aims: Decreasing blood loss during total hip replacement (THR) remains a challenge for the orthopaedic surgeon. This study investigated the effects of the antifibrinolytics aprotinin and epsilon aminocaproic acid (EACA) against placebo on blood loss during primary total hip replacement. Their safety and mechanism of action was also investigated. Method: Forty-five patients undergoing primary unilateral total hip arthroplasty were randomised to receive an infusion of either aprotinin, EACA, or placebo. Intra- and post-operative blood loss was measured, as was the rate of blood transfusion and changes in haemoglobin concentration. Clinical examination and duplex ultrasound was used in all patients to detect thrombotic events. All patients were assessed clinically six weeks post-op to detect adverse events. Platelet function was assessed using P-selectin, Platelet-monocyte aggregates (PMA) and factor V/Va levels. D-dimer activity was recorded as an indicator of fibrinolysis. Non-parametric statistical analysis was employed in the interpretation of results. Results: There was no difference in demographics or pre-operative platelet function between the groups with the exception of the EACA group which had a lower pre-operative haemoglobin concentration. Intra-operative blood loss was significantly lower in the aprotinin group compared to placebo (p=0.01), similarly there was also a reduction in intra-operative blood loss in the EACA group but this did not reach statistical significance. Post-operative bleeding from closed suction drains was markedly reduced for both aprotinin (60%, p=< 0.01) and EACA (53%, p=< 0.001) compared to placebo. Markedly less haemoglobin was lost in drains in both antifibrinolytic groups, with aprotinin showing a 77% (p=< 0.0001) and EACA a 73% reduction (p=< 0.001) in post-operative haemoglobin loss. Despite this, no difference in the rate of blood transfusion was observed between groups. Total hip arthroplasty surgery led to the activation of platelets as evidenced by P-selectin, PMA and factor V/Va levels. However, platelet function was not affected by either aprotinin or EACA. Both antifibrinolytics showed a similar increase in D-dimer levels indicating a similar efficacy in inhibiting fibrinbolysis. There were no DVTs, PEs or infections recorded in the study, and no increase in adverse events was seen with the use of antifibrinolytics. Conclusion: Infusion of either aprotinin or EACA reduces blood loss after primary THA. Both agents are equally effective and have a favourable safety profile. The two drugs inhibit fibrinolysis in a similar fashion, and this action appears to be independent of platelets

Introduction: Adequately managing post-operative pain following ankle and hindfoot surgery can be difficult. Conventional analgesics have significant side effects including nausea and gastric irritation. The results of a pilot study of continuous infusion v’s single bolus popliteal block encouraged us to perform the full PRCT. Method: The trial was approved by the local Research and Ethics Committee and registered with the European Clinical Trials Database. Approval was obtained from the Medicines and Healthcare products Regulatory Authority (MHRA) for the use of normal saline infusion as a placebo. The recommendations of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use were respected. Inclusion criteria were all patients who were undergoing significant hind foot or ankle procedures. Exclusion criteria included coexisting peripheral neuropathy and any inability to fill in the questionnaire. The pilot study provided a standard deviation of pain scores which allowed us to calculate the sample size required; 25 patients in each group would have 90% power to detect a difference in means VAS scores of 3 which we considered to be clinically significant. A total number of 56 (to allow for 10% loss to follow-up) were recruited. The patients and the assessors were blinded to the treatment allocated. Sealed envelopes contained random allocations and were opened by the anaesthetist. A bolus of 20ml 0.25% bupivacaine was injected and then the catheter was inserted and connected to a pump. Patients were randomly assigned to receive either an infusion of normal saline or bupivacaine over the next 72 hours. The patients were asked to complete a visual analogue pain chart, three times daily, for 72 hours postoperatively. Data was also recorded regarding supplementary opiate analgesic requirements and any problems or complications. Statistical analysis was performed using MedCalc for Windows, version 9.6.4 (MedCalc software, Mariakerke, Belgium). A Mann-Whitney U test was used for the non-parametric data sets. Results: Both groups had very low median VAS pain scores on the day of operation and there was no difference between the two; study 1.167, control 1.000 (p=0.893). On the 3 post operative days studied there were significantly lower pain scores in the study group; day 1: 1.67 v’s 3.67 (p=0.003), day 2: 1.33 v’s 2.83 (p=< 0.001), day 3: 1.11 v’s 2.56 (p=< 0.001). There was no difference in median milligrams of morphine usage on the day of operation; study = 10, placebo = 10 (p = 0.942). The morphine usage was lower in the study group on all post operative days and this was significant on days 2& 3; day 1: 10 v’s 15 (p=0.054), day 2: 10 v’s 20 (p=< 0.001), day 3: 7.5 v’s 10 (p=0.02). Median total morphine requirements over the 3 post operative days were 30mg for the study group compared to 52.5mg for the control group and this was significant (p=0.012). The study group on average spent less nights as an inpatient with a median value of 1 compared to 2 for the control but this was not significant (p=0.430). There were no major complications with the administration of the blocks or with the catheters. Conclusion: The bolus of bupivacaine given to all patients prior to surgery meant that low pain scores were seen in both groups in the immediate post operative period with no significant difference between them. The continuous infusion of bupivacaine via a pain pump provided significantly better analgesia than normal saline with significantly less requirement for supplementary oral analgesic agents over the 72 hours after major ankle or hind foot surgery. This is a safe and effective method of managing post operative pain in these patients

120 patients undergoing primary TKR/THR were randomised to receive ferrous sulphate (FS) or placebo (P) for three weeks following their arthroplasty. Haemoglobin levels and absolute reticulocyte counts were measured at days 1 and 5, and weeks 3 and 6. Ninety-nine patients FS (50), P (49) completed the study. The two groups differed only in treatment administered. Haemoglobin recovery was similar at day 5 and by week 3, haemoglobin levels recovered to 85% of their pre-operative levels, irrespective of treatment group. A small but greater recovery in haemoglobin level was identified at 6 weeks in the FS group for females (6% Vs 3%) and males (5% Vs 1.5%). The clinical significance of this is questionable and may be outweighed by the high incidence of reported side effects of oral iron, and the economic costs of the medication. Administration of iron supplements following elective TKR or THR does not appear to be a worthwhile practice