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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 11 - 11
2 Jan 2024
Petrucci G Papalia GF Russo F Ambrosio L Papalia R Vadalà G Denaro V
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Chronic low back pain (CLBP) is the most common cause of disability worldwide, and lumbar spine fusion (LSF) is often chosen to treat pain caused by advanced degenerative disease when clinical treatment failed certain cases, the post-surgical outcomes are not what was expected. Several studies highlight how important are. In psychological variables during the postoperative spine surgery period. The aim of this study is to assess the role of preoperative depression on postoperative clinical outcomes. We included patients who underwent LSF since December 2021. Preoperative depression was assessed administering Beck Depression Inventory questionnaire (BDI). And pain and disability were evaluated at 1, 3, and 6 months, administering respectively Visual Analogic Scale (VAS) and Oswestry Disability Index (ODI). As statistical analysis Mann-Whitney test was performed. We included 46 patients, 20 female (43,5%) and 26 male (56,5%) with an average age of 64,2. The population was divided in two groups, fixing the BDI cut-off point at 10. Patients with BDI < 10 points (N=28) had normal mental health status, instead patients with BDI > 10 points (N=16) had depressive disorders. At 3 months patients with healthy mental status reported statistically significant reduction of pain (U = 372,5, p = .006) and improvement of disability but without statistical significancy (U = 318, p = 0,137). At 6 months patients without psychological disease reported statistically significant reduction of pain (U = 342, p = 0,039) and disability (U = 372,5, p = 0,006).

This study demonstrates the correlation between pre-existing depressive state and poorer clinical outcomes after spine surgery. These results are consistent with the literature. Therefore, during the surgical decision making it is crucial to take psychological variables into account in order to predict the results after surgery and inform patients on the potential influence of mental status.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 85 - 85
1 Mar 2021
Hussain A Poyser E Mehta H
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Abstract

Introduction

Local anaesthetic injections are regularly used for perioperative pain relief for shoulder arthroscopies. In our practice all shoulder arthroscopies were performed under general aneasthesia supplemented by perioperative subacromial local anaesthetic injections or landmark guided axillary nerve together with suprascapular nerve injections. We compared pain relief achieved with these two methods. We hypothesized that the selective nerve blocks would provide better post operative pain relief as described in literature.

Methods

We conducted a retrospective cohort study on two patient groups with 17 patients each. Group one patients received 20mls 50:50 mixture of 1% lignocaine and 0.5% chirocaine injections before and after start of procedure and group two patients received 20 mls of chirocaine around the axillary and suprascapular nerves. VAS scores were collected at 1 and 4 hours and analgesia taken during the first 24 hours was recorded.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 149 - 149
11 Apr 2023
Gagnier J O'Connor J
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We sought to determine the relationship between patient preoperative psychological factors and postoperative THA outcomes. We performed an electronic search up to December 2021 using the following terms: “(mental OR psychological OR psychiatric) AND (function OR trait OR state OR predictor OR health) AND (outcome OR success OR recovery OR response) AND total joint arthroplasty)”. Peer-reviewed, English language studies regarding THA outcomes were analyzed for preoperative patient mental health metrics and objective postoperative results regarding pain, functionality and surgical complications. We extracted study data, assessed the risk of bias of included studies, grouped them by outcome measure and performed a GRADE assessment. Seventeen of 702 studies fulfilled inclusion criteria and were included in the review. Overall, compared to cohorts with a normal psychological status, patients with higher objective measures of preoperative depression and anxiety reported increased postoperative pain, decreased functionality and greater complications following THA. Additionally, participants with lower self-efficacy or somatization were found to have worse functional outcomes. Following surgery, both early and late pain scores remained higher in patients with preoperative depression and anxiety. Preoperative depression and anxiety may negatively impact patient reported postoperative pain, physical function and complications following THA. A meta-analysis was not performed because of the heterogeneity of studies, specifically the use of differing pain scales and measures of physical and psychological function as well as varied follow-up times. Future research could test interventions to treat pre-operative depression or anxiety and explore longitudinal outcomes in THA patients. Surgeons should consider the preoperative psychological status when counseling patients regarding expected surgical outcomes and attempt to treat a patient's depression or anxiety prior to undergoing total hip arthroplasty


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 105 - 105
4 Apr 2023
Kale S Mehra S Bhor P Gunjotikar A Dhar S Singh S
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Total Knee Arthroplasty (TKA) improves the quality of life of osteoarthritic and rheumatoid arthritis patients, however, is associated with moderate to severe postoperative pain. There are multiple methods of managing postoperative pain that include epidural anesthesia but it prevents early mobilization and results in postoperative hypotension and spinal infection. Controlling local pain pathways through intra-articular administration of analgesics is a novel method and is inexpensive and simple. Hence, we assess the effects of postoperative epidural bupivacaine injection along with intra-articular injection in total knee replacement patients. The methodology included 100 patients undergoing TKA randomly divided into two groups, one administered with only epidural bupivacaine injection and the other with intra-articular cocktail injection. The results were measured based on a 10-point pain assessment scale, knee's range of motion (ROM), and Lysholm knee score. The VAS score was lower in the intra-articular cocktail group compared to the bupivacaine injection group until the end of 1-week post-administration (p<0.01). Among inter-group comparisons, we observed that the range of motion was significantly more in cocktail injection as compared to the bupivacaine group till the end of one week (p<0.05). Lysholm's score was significantly more in cocktail injection as compared to the bupivacaine group till the end of one week (p<0.05). Our study showed that both epidural bupivacaine injection and intra-articular injection were effective in reducing pain after TKA and have a comparable functional outcome at the end of 4 weeks follow up. However, the pain relief was faster in cases with intra-articular injection, providing the opportunity for early rehabilitation. Thus, we recommend the use of intra-articular cocktail injection for postoperative management of pain after total knee arthroplasty, which enables early rehabilitation and faster functional recovery of these patients


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 44 - 44
1 Nov 2021
Salhab M Sonalwalkar S Anand S
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Introduction and Objective. Objectives: To determine the effectiveness of LIA compared to ACB in providing pain relief and reducing opiates usage in hamstring graft ACL reconstructions. Materials and Methods. In a consecutive series of hamstring graft ACL reconstructions, patients received three different regional and/or anaesthetic techniques for pain relief. Three groups were studied: group 1: general anaesthetic (GA)+ ACB (n=38); group 2: GA + ACB + LIA (n=31) and group 3: GA+LIA (n=36). ACB was given under ultrasound guidance. LIA involved infiltration at skin incision site, capsule, periosteum and in the hamstring harvest tunnel. Analgesic medications were similar between the three groups as per standard multimodal analgesia (MMA). Patients were similar in demographics distribution and surgical technique. The postoperative pain and total morphine requirements were evaluated and recorded. The postoperative pain was assessed using the visual analogue scores (VAS) at 0hrs, 2hrs, 4hrs, weight bearing (WB) and discharge (DC). Results. There was no statistically significant difference in opiates intake amongst the three groups. When comparing VAS scores; there were no statistical difference between the groups at any of the time intervals that VAS was measured. However, the GA+LIA group hospital's LOS (m=2.31hrs, SD=0.75) was almost half that of GA+ACB group (m=4.24hrs, SD=1.08); (conditions t(72)=8.88; p=0.000). There was no statistical significance in the incidence of adverse effects amongst the groups. Conclusions. The LIA technique provided equally good pain relief following hamstring graft ACL reconstructions when compared to ACB, while allowing for earlier rehabilitation, mobilisation and discharge


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 121 - 121
1 Nov 2021
Salhab M Cowling P
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Introduction and Objective. Postoperative pain control in shoulder surgery is challenging even in arthroscopic procedures. Acute postoperative pain can last up to 48hrs despite using multimodal analgesia. Different techniques have been used to control acute pain following shoulder surgery. The most common technique currently used in shoulder surgery at the elective orthopaedic centre in Leeds is a combination of general anaesthetic (GA) and interscalene block (ISB). ISB maybe very effective, however, carries many risks and potential side effects such as brachial plexus injury and paralysis of the vagus and laryngeal recurrent nerves as well as cervical sympathetic nerve and pneumothorax. ISB can also be associated with higher incidence of neurological deficit compared to other peripheral nerve blocks; up to 14% at 10 days in some cases. As such we decided to examine the use of ISB for achieving pain control in our elective unit. Materials and Methods. A prospective consecutive series of 217 patients undergoing shoulder surgery were studied. These were grouped into 10 groups. All procedures were arthroscopic apart from shoulder arthroplasty procedures such as hemiarthroplasty and total shoulder replacements (TSRs). The choice of regional anaesthesia was ISB with GA as standard practice. Visual analogue scores (VAS) at 0hrs, 1hr, 2hrs, 4hrs and 6hrs; and total opiates intake were recorded. A one-way single factor ANOVA was used as preferred statistical analytical method to determine whether there is a difference in VAS scores and total opiates intake amongst the groups. Postoperative analgesics were used for pain relief, although these were not standardised. Results. In total shoulder replacement group, although the RSR group used more morphine on average compared to the ASR group (Mean morphine intake 6.5mg vs 3mg), this was not statistically significant (F<Fcrit; p value= 0.19). When comparing all the arthroplasty groups, the difference in mean morphine intake was also statistically not significant (F<Fcrit; p value=0.24). However, when comparing all 10 groups’ morphine intake there was a statistically significant difference amongst these groups (F>F crit; p value=0.03). Interestingly, there was a statistically significant difference in VAS at 0hrs (F>Fcrit p value=0.01); 1hrs (F>Fcrit; p value=0.00), and at 6hrs (F>Fcrit; p value=0.02) when comparing all 10 groups. Conclusions. ISB is an effective technique in achieving pain control in shoulder surgery; however, there are still variations in analgesic needs amongst groups and the use of alternative techniques should be thus explored. A future prospective study looking at acute pain for a longer period of time after shoulder surgery would explore the effectiveness of ISB in achieving pain control consistent with rehabilitation requirements


Bone & Joint 360
Vol. 13, Issue 1 | Pages 44 - 45
1 Feb 2024
Marson BA

This edition of the Cochrane Corner looks at the three reviews that were published in the second half of 2023: surgical versus non-surgical interventions for displaced intra-articular calcaneal fractures; cryotherapy following total knee arthroplasty; and physical activity and education about physical activity for chronic musculoskeletal pain in children and adolescents.


Bone & Joint 360
Vol. 13, Issue 2 | Pages 47 - 49
1 Apr 2024
Burden EG Krause T Evans JP Whitehouse MR Evans JT


Bone & Joint 360
Vol. 11, Issue 4 | Pages 44 - 46
1 Aug 2022
Evans JT Walton TJ Whitehouse MR


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 113 - 113
1 Jan 2017
Boriani F Granchi D Roatti G Merlini L Sabattini T Baldini N
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The postoperative course of median nerve decompression in the carpal tunnel syndrome may sometimes be complicated by postoperative pain, paresthesias, and other unpleasant symptoms, or be characterized by a slow recovery of nerve function due to prolonged preoperative injury causing extensive nerve damage. The aim of this study is to explore any possible effects of alpha lipoic acid (ALA) in the postoperative period after surgical decompression of the median nerve at the wrist. Patients were enrolled with proven carpal tunnel syndrome and randomly assigned into one of two groups: Group A: surgical decompression of the median nerve followed by ALA for 40 days. Group P: surgical decompression followed by placebo. The primary endpoint of the study was nerve conduction velocity at 3 months post surgery, Other endpoints were static 2 point discrimination, the Boston score for hand function, pillar pain and use of pain killers beyond the second postoperative day. ALA did not show to significantly improve nerve conduction velocity or Boston score. However, a statistically significant reduction in the postoperative incidence of pillar pain was noted in Group A. In addition, static 2 point discrimination showed to be significantly improved by ALA. Administration of ALA following decompression of the median nerve for carpal tunnel release is effective on nerve recovery, although this is not detectable through nerve conduction studies but in terms of accelerated and improved static two-point discrimination. The use of ALA as a supplementation for nerve recovery after surgical decompression may be extended to all types of compression syndromes or conditions where a nerve is freed from a mechanical insult. Furthermore, ALA limits post-decompression pain, including late pericicatricial pain at the base of the palm, the so called pillar pain, which seems to be associated with a reversible damage to the superfical sensitive small nerve fibers. In conclusion postoperative administration of ALA for 40 days post-median nerve decompression was positively associated with nerve recovery, induced a lower incidence of postoperative pillar pain and was associated with a more rapid improvement of static two-point discrimination. This treatment is well tolerated and associated with high levels of satisfaction and compliance, supporting its value as a standard postoperative supplementation after carpal tunnel decompression


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 57 - 57
1 May 2017
Salhab M Macdonald D Kimpson P Freeman J Stewart T Stone M
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Background. Hip arthroplasties are associated with high postoperative pain scores. In some reports, moderate to severe pain was 58% on the first day postoperatively in total hip replacements (THRs). Several techniques are currently used at our institution to tackle acute pain following THRs. These include: 1) Spinal anaesthetic (SA) with Diamorphine only; 2) General anaesthetic (GA) only; 3) SA with local infiltration anaesthetic mixture 1 (LIA1,). Mixture 1 consisted of ropivacaine, adrenaline, and ketorolac; 4) SA with LIA mixture 2 (LIA2). Mixture 2 consisted of bupivacaine and adrenaline; 5) SA with LIA1 and PainKwell pump system. In this study we report on the techniques of acute pain control following THR at our regional centre for elective primary THRs. Methods. Between June 2011 and July 2014, 173 consecutive patients undergoing primary THR using the posterior approach were prospectively followed up. Group 1. GA only. 31 patients, Group 2. SA only. 37 patients, Group 3. SA plus LIA1 only. 38 patients, Group 4. SA plus LIA2 only, 34 patients, Group 5. SA plus LIA1 plus PainKwell Pump System for 48 hours. 33 patients. Results. Fewer patients required opiate analgesia when LIA plus PainKwell pump system was used compared to the other groups. The highest significance was at 0–12 hrs for patients requiring up to 20mg morphine usage (χ2(2) = 46.713, p = 0.000); and 0–12hrs for patients requiring 30mg morphine usage (χ2(2) = 46.310, p = 0.000). There were no infections, DVTs or PEs in any group. One patient in group 3 suffered a stroke (ASA 4). A Kruskal-Wallis H test also showed that there was a statistically significant difference in morphine usage across groups 1, 2, 3, 4, and 5. Conclusion. We recommend the use of LIA with PainKwell pump system continuous infusion as an efficacious method to control pain following THR


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 119 - 119
1 Jan 2017
Vidal Rodriguez S
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Lumbar disc herniation represents by far the most prevalent pathology, causing pain and sciatica and constitutes an important cause of disability and one of the most cost-intensive health problems. The aetiology is very complex. In recent years, it has been suggested in twin and family studies that genetic risk factors contribute to the development of LDH. Our purpose is to analyse genetic susceptibility to symptomatic LDH in Spanish surgical patients treated with different surgical techniques. Single-nucleotide polymorphisms (SNPs) in VDR, GDF5, Col1A1, THBS2 and CHST were genotyped in a case-control study with 50 symptomatic LDH in Spanish surgical patients and 50 Spanish health controls. All patients provided signed informed consent. Sampling was carried out with a puncture of the pad of a finger using a sterile, single-use lancet. SNPs were determined by real-time polymerase chain reaction (PCR) using specific, unique probes with the analysis of the melting temperature of hybrids. The X2 test compared genotypes between groups. Multivariate logistic regression analysed the significance of many covariates and the incidence of LDH. We found significant differences in age, gender and smoking status between the two groups. There were significant differences in the CC (rs2228570) genotype in VDR in patients with LDH (p<0.05). There were significant differences in the GT (rs1800012) genotype in Col1A1 in patients with LDH (p=0.001). In Col1A1, T allele was more frequent in the case group than in the control group (p<0.001). Regarding surgical techniques, of the 50 patients included in the cases group, 25 were treated with open microdiscectomy and 25 received endoscopic discectomy. Outcomes were assessed at 12 months using VAS, and NASS instrument. Postoperative pain and pain medication were significantly reduced in the endoscopic group. Patient satisfaction is greater in the endoscopic group, with shorter hospital stays and earlier return to normal activity. GT genotype in Col1A1 was more frecuent in the endoscopic group compared to the microdiscectomy group (p=0.002). CC genotype in VDR and GT genotype in Col1A1 are associated with symptomatic LDH susceptibility in Spanish surgical patients. GT genotype in Col1A1 is associated with symptomatic LDH treated with full-endoscopic discectomy


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_16 | Pages 46 - 46
1 Oct 2016
Nair A Dolan J Tanner KE Pollock PJ Kerr C Oliver FB Watson MJ Jones B Kellett CF
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Adductor canal blocks offer an alternative to femoral nerve block for postoperative pain relief in knee arthroplasty. They may reduce the risk of quadriceps weakness, allowing earlier mobilisation of patients postoperatively. However, little is known about the effect of a tourniquet on the distribution of local anaesthetic in the limb. Ultrasound-guided adductor canal blocks were performed on both thighs of five human cadavers. Left and right thighs of each cadaver were randomised to tourniquet or no tourniquet for one hour. Iohexol radio-opaque contrast (Omnipaque 350) was substituted for the local anaesthetic for X-Ray imaging. All limbs underwent periodic flexion and extension during this hour to simulate positioning during surgery. The cadavers were refrozen. Fiducial markers were inserted into the frozen tissue. X-rays were obtained in 4 planes (AP, lateral 45° oblique/medial oblique, lateral). University Research Ethics Approval was obtained and cadavers were all pre-consented for research, imaging and photography according to the Anatomy Act (1984). Analysis of radiographs showed contrast distribution in all thighs to be predominantly on the medial aspect of the thighs. The contrast margins were entire and well circumscribed, strongly suggesting it was largely contained within the aponeurosis of the adductor canal. Tourniquets appeared to push the contrast into a narrower and more distal spread along the length of the thigh compared to a more diffuse spread for those without. Proximal spread towards the femoral triangle was reduced in limbs without tourniquets. The results suggest that contrast material may remain within the adductor canal structures during adductor canal blocks. Tourniquets may cause greater distribution of contrast proximally and distally in the thigh, but this does not appear to be clinically significant. Further studies might include radio-stereo photometric analysis using the fiducial markers in the limbs and in vivo studies to show the effect of haemodynamics on distribution


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_16 | Pages 37 - 37
1 Oct 2016
Kurien T Kerslake R Scammell B Pearson R
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A subgroup of patients that undergo TKR surgery have evidence of neuropathic pain and central sensitization that may predispose to severe postoperative pain. This study assesses the correlation of MRI detected bone marrow lesions (BMLs) and synovitis with markers of neuropathic pain and central sensitization in patients undergoing TKR surgery and healthy volunteers. 31 patients awaiting TKR and 5 healthy volunteers were recruited. Each subject underwent a 3-T knee MRI scan that was graded for BMLs (0–45) and synovitis (0–3) using subsets of the MRI Osteoarthritis Knee Score (MOAKS). All subjects were asked to complete the PainDetect questionnaire to identify nociceptive pain (< 13), unclear pain (13–18) and neuropathic pain (>18). Correlation between BMLs and PainDetect score was the primary outcome measure. Secondary outcomes included the correlation of synovitis to PainDetect and temporal summation (TS) a measure of central sensitization to the PainDetect score. TS was determined using a monofilament to evoke pain. Pilot histological analysis of the prevalence of osteoclasts (TRAP. +. ) within BMLs versus normal subchondral bone was performed, implying a role in BML pathology. Increasing BML MOAKS score correlated with neuropathic pain (painDetect), r. s. = 0.38, p=0.013 (one-tailed). There was a positive correlation between synovitis and PainDetect score, τ =0.23, p= 0.031 (one-tailed). TS was greater in the neuropathic pain than in nociceptive pain patients, U = 18.0, p=0.003 (one-tailed). TRAP staining identified more osteoclasts within BMLs than contralateral condyle lesion free subchondral bone, z = −2.232, p = 0.026 (Wilcoxon Signed Rank Test, one-tailed). BMLs and synovitis are more prevalent in neuropathic pain and central sensitization in knee OA. Higher osteoclast prevalence was seen within BMLs which may help explain the association with BMLs and pain in OA


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_16 | Pages 39 - 39
1 Oct 2016
Kurien T Reckziegel D Cottam W Petersen K Ardent-Nielsen L Graven-Nielsen T Pearson R Auer D Scammell B
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Painful OA is linked to CNS changes in pain processing. Temporal summation of pain (TSP) is a measure of one such CNS change, central sensitization. TSP is defined using a series (≥0.33Hz) of painful stimuli and is a predictor of postoperative pain, experienced by 20% of patients after total knee replacement (TKR) surgery. This study has developed a protocol to use functional MRI to assess CNS changes in OA pain processing. This pilot includes 3 participants with chronic knee OA pain awaiting TKR (62 ± 4.4) and 5 healthy volunteers (50 ± 13.6). 3-Tesla BOLD fMRI brain scans were recorded during short series of one second painful stimuli, applied using an automated inflatable cuff to the calf muscle of the leg with the affected knee or left side in healthy volunteers. The pain intensity at onset and during the 10 painful stimuli were recorded using a numerical rating scale. The pattern of brain activation was averaged across noxious stimuli, and the differential activation compared the 1st vs. 10th (last) stimulus. Bone marrow lesions (BMLs), synovitis and effusion size were scored from 3-Tesla knee MRI's using MOAKS scoring. TSP was raised in OA patients compared to control group (p=0.023). TSP brain activity in the chronic OA patients displayed higher signal within the subgenual anterior cingulate (sgACC) compared to healthy volunteers. Knee MRI identified OA patient's exhibited higher BML scores (p=0.038) and more knee effusion (p=0.018), but the lack of synovitis did not differ from control group (p=0.107). Enhanced TSP in chronic knee OA pain may be linked with augmented responses in emotional circuitry. BMLs and effusion size appear to contribute more with pain than synovitis. These results may help understand sensitization to improve outcomes for patients with knee OA undergoing TKR surgery


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 56 - 56
1 Jan 2017
García-Rey E Gómez-Barrena E García-Cimbrelo E
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Total hip replacement (THR) in young patients has been associated to higher revision rates than in older population. Different conditions may lead to end-stage arthritis of the hip in these patients. We compared the clinical and radiological outcome of two different groups of young and very young patients who underwent a ceramic-on-ceramic THR. 120 hips were prospectively followed for a mean of 10.4 years (range, 5 to 17). 38 patients (46 hips) were less than 30 years old (group 1), and, 68 (74 hips) were between 31 and 40 years old (group 2). Weight (p<0.001) and physical activity level were greater in group 2 (p<0.001). Preoperative function (p=0.03) and range of mobility (p=0.03) were worse in group 1. Primary osteoarthritis was not found in any case. Rheumatoid juvenile arthritis was the most frequent diagnosis in group 1 and avascular necrosis of the femoral head in group 2. A femoral funnel-shaped type 1 according to Dorr was more frequent in group 2 (p=0.04). The same ceramic-on-ceramic uncemented THR was used in all cases. Screws for cup fixation were only used when strictly needed. We analysed the clinical results according to the Merle-D´Aubignè and Postel scale, the postoperative radiological reconstruction of the hip and the radiological appearance of cup loosening. Kaplan-Meier survivorship analysis was used to estimate the cumulative probability of not having a revision surgery. Screw use required to obtain a secured interference fit of the acetabular component was found more frequently in group 1 (p=0.01). Postoperative pain (p=0.002) and function (p=0.002) were better in group 1. Mean acetabular abduction angle of the cup was greater in group 1 (p=0.03) and reconstruction to the hip rotation center according to Ranawat (p=0.01) was better in group 2. Placement of the acetabular component inside the Lewinnek´s zone and stem position were similar in both groups. No hips were revised due to complications related to ceramic or to stem loosening. Three cups were revised for aseptic loosening in group 1 and four in group 2. The survival rate for cup aseptic loosening at 15 years was 92.3% (95% CI: 83.7 to 100) for group 1 and 93.1% (95% CI: 85.3 to 99.9) for group 2 (Log rank, p=0.88). Ceramic-on-ceramic uncemented THR is an excellent option for young and very young patients. Despite worse preoperative conditions in patients under the age of 30 years, a similar clinical outcome was found in this series


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 114 - 114
1 Jan 2017
Bertolotti M Pizà-Vallespir B Nizzardo A Cuadripani S Contini M Guerrero-Bayón C Paredes-Lario I Scartoni S Capriati A
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The goals of perioperative management are to relieve pain, achieve early mobilization after surgery, reduce length of hospital stay, and obtain adequate patient satisfaction. Several treatment options combining systemic analgesics and/or regional analgesia with or without opioids are available for postoperative pain; however, a gold standard has not been established although there is a progressive shift towards multimodal approaches to improve analgesia while minimizing opioid-related side effects. EX-TRA-05 (DAVID-ART) was a randomised, double-blind, parallel, pivotal study, evaluating the analgesic efficacy and safety of the innovative oral combination of dexketoprofen/tramadol 25mg/75mg in comparison with the individual components (tramadol given at the higher dose of 100mg) on moderate to severe acute pain after total hip replacement. Repeated doses of study drug were administered every 8 hours and pain intensity (PI) was to be scored according to a 100mm visual analogue scale (VAS) on a programmed e-diary every 2 hours over a 56-hour period (i.e. along 7 repeated doses). A placebo arm was included at the first administration to validate the pain model. Rescue medication, metamizole 500mg, was available during the treatment period. The study primary endpoint was the mean sum of the pain intensity difference values throughout the first 8 hours (SPID. 8. ), which considered the 3 active treatment arms and placebo (ITT population; N=641). In this phase, a clear superiority of the combination over the single agents was demonstrated (p<0.05). An additional analysis was performed during the entire 0–56h repeated-dose period excluding those patients who had received placebo at the first dose (N=161). The estimated mean (SE) differences on PI-VAS over 24, 32 and 56 hours post first dose (0–24h, 0–32h, and 0–56h) between the combination and each single agent were evaluated. Patients who received active analgesic from the first dose (mITT population; N=480) were aged 29–80 years (42% were ≥65 years). At randomisation, pain was moderate (≥40–60mm) in 51% patients and severe (>60mm) in 49%. For dexketoprofen/tramadol, mean (SD) PI-VAS values were 22 (4.0) over 24 hours; 21 (4.1) over 32 hours; and 19 (3.8) over 56 hours. The estimated differences versus dexketoprofen 25mg and tramadol 100mg were respectively 10 (0.7) and 7.6 (0.7) over 24 hours; 9.8 (0.6) and 7.2 (0.6) over 32 hours; and 8.1 (0.5) and 6.3 (0.5) over 56 hours (p<0.0001 for all comparisons), which confirmed the superiority of the combination versus both single agents throughout the periods analysed. This significant higher decrease of PI favouring dexketoprofen/tramadol 25mg/75mg over dexketoprofen 25mg and tramadol 100mg, all given every 8 hours, during the first 56 hours post dose confirmed the superior analgesia shown after the first 0–8h post-dose period. The combination of dexketoprofen/tramadol 25mg/75mg is able to provide a level of analgesia above that achievable by each component alone, with a sustained effect when used as a multiple-dose regimen. The addition of this new combo to the analgesic armamentarium may contribute to facilitate early mobilization after surgery, thus positively impacting perioperative co-morbidities and length of in-hospital stay


Bone & Joint 360
Vol. 9, Issue 3 | Pages 8 - 9
1 Jun 2020


Bone & Joint 360
Vol. 7, Issue 1 | Pages 38 - 39
1 Feb 2018
Das A


Bone & Joint 360
Vol. 7, Issue 3 | Pages 38 - 39
1 Jun 2018
Das A