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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 65 - 65
1 Feb 2012
Dahabreh Z Sturdee S Templeton P Cullen E Giannoudis P
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Background. The aim of this study was to identify and quantify any benefits of early active treatment of paediatric femoral shaft fractures for patients, their families, and the hospital. Patients and methods. Our protocol (1999-2002) uses flexible intramedullary nails for children older than five, early hip spica (within one week of injury) for the under five year olds, and external fixation for polytrauma (Early Active Group[EAG], n = 25). Prior to this (1999-2002), treatment consisted of late application of a hip spica (3-4 weeks following injury) or inpatient traction (Traditional Group [TG], n = 41). Outcome measures were length of hospital stay, degree of malunion, knee and hip movements, and leg length discrepancy. The financial burden to the family including waged and non-waged time lost, transport, childminder, and other extra costs were estimated. Hospital costs including inpatient stay, theatre, and implant costs were analysed. Results. A 40% reduction in the incidence of femoral fractures over the six-year period was noted. Mean hospital stay was 29 and 10 nights (p<0.001); family costs were £1,243 and £968; and hospital costs were £10,831 and £4,291 per patient (p<0.005) in the TG and the EAG respectively. Parents in both groups preferred early discharge (86%-94%). In the EAG, 10 patients were short at 3 months (0.5 - 3 cm). None was short at 2 years. Eight children were long at 2 years. At 2 years, all had good clinical and functional results. There was no significant difference in the mal-union rate between the two groups. All the fractures united by three months. Five out of nine complications occurred in the EAG. Conclusion. The use of our early active treatment protocol has resulted in a significant reduction in hospital stay, costs to the families and the hospital


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 120 - 120
1 Mar 2006
Sturdee S Dahabreh Z Templeton P Cullen E
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The aim of this study was to compare the modern treatments for femoral fractures in children to see if they have any advantages over traditional treatments. The modern treatments are mainly operative with the objective is to get the children mobilising early and to minimise the time spent in hospital. We studied 66 children who had sustained a traumatic femoral shaft fracture, over a six-year period with a minimum follow up of two years. A protocol using early hip spicas for under 5 year olds, flexible intramedullary nails for over 5 year olds, and external fixation for the polytrauma cases was started in 1999. Over a three-year period there were 25 children who sustained a fracture (Early active group). These were prospectively reviewed with a minimum follow up of 24 months. The outcome measures being, length of hospital stay, degree of mal-union, range of movement of the hip and knee, leg length discrepancy, pain and functional restrictions. This modern patient group was compared with all the fractures in the three years prior to the new protocol commencing. This group were treated usually with in patient traction (Traditional group). There were 41 children in this group who had sustained a fracture between 1996 and 1999.

The mean length of hospital stay was 32 nights in the traditional group and 19 nights in the early active group (p less than 0.001). If we exclude the children who were severely injured with multiple injuries the mean stay is 29 nights and 10 nights (p less than 0.001). There was no significant difference in the mal-union rate between the two groups. Very few had pain and at 2 years they all had good clinical and functional results. The only significant complication rate was with the fractures that were treated with an external fixator. These were mainly pin site infections. In our population there has been a 40% reduction in the incidence of femoral fractures over the six-year period for which we have no explanation.

These modern treatments have resulted in a shorter hospital stay that has many advantages for the child and family as well as financial savings.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 729 - 734
1 Jul 2023
Borghi A Gronchi A

Desmoid tumours are a rare fibroblastic proliferation of monoclonal origin, arising in deep soft-tissues. Histologically, they are characterized by locally aggressive behaviour and an inability to metastasize, and clinically by a heterogeneous and unpredictable course. Desmoid tumours can occur in any anatomical site, but commonly arise in the limbs. Despite their benign nature, they can be extremely disabling and sometimes life-threatening, causing severe pain and functional limitations. Their surgical management is complex and challenging, due to uncertainties surrounding the biological and clinical behaviour, rarity, and limited available literature. Resection has been the first-line approach for patients with a desmoid tumour but, during the last few decades, a shift towards a more conservative approach has occurred, with an initial ‘wait and see’ policy. Many medical and regional forms of treatment are also available for the management of this condition, and others have recently emerged with promising results. However, many areas of controversy remain, and further studies and global collaboration are needed to obtain prospective and randomized data, in order to develop an appropriate shared stepwise approach.

Cite this article: Bone Joint J 2023;105-B(7):729–734.


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 109 - 111
1 Feb 2023
Karjalainen T Buchbinder R

Tennis elbow (lateral epicondylitis or lateral elbow tendinopathy) is a self-limiting condition in most patients. Surgery is often offered to patients who fail to improve with conservative treatment. However, there is no evidence to support the superiority of surgery over continued nonoperative care or no treatment. New evidence also suggests that the prognosis of tennis elbow is not influenced by the duration of symptoms, and that there is a 50% probability of recovery every three to four months. This finding challenges the belief that failed nonoperative care is an indication for surgery. In this annotation, we discuss the clinical and research implications of the benign clinical course of tennis elbow.

Cite this article: Bone Joint J 2023;105-B(2):109–111.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 280 - 280
1 May 2009
Albert H Manniche C
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Background: Reviews have showed none or little efficacy of passive conservative treatment modalities for patients with sciatica, reviews on surgery are conflicting. Cohort studies have shown high efficacy of active conservative treatment for patients with sciatica. The aim was to evaluate the efficacy of two active conservative treatment programs to patients with severe sciatica. Methods: The study was a prospective single-blind randomized clinical controlled trial of 181 consecutive patients with radicular pain below the knee. The patients were examined at baseline, 8 weeks later at post treatment follow-up, and at one year follow-up. In both groups treatment consisted of thorough Information concerning anatomy, pathogenesis, how discs heal without surgery, and Advice and encouragement to stay as active as possible, and optional medication. Then either Symptom guided exercises or Sham exercises. Results: All patients experienced a highly significant and clinically important improvement in global assessment, functional status, pain, vocational status, and clinical findings. The Symptom guided exercises + Information + Advice to stay active group (SYMIA) was significantly superior to the Sham exercises + Information + Advice to stay active group (SHAMIA) with regards to global assessment, clinical findings, sick leave and vocational status both at end of treatment and one year follow-up. There was a borderline significant difference in leg pain at end of treatment, and no difference was found in RMQ and EQ-5D. Conclusion: Patients who had symptoms and clinical findings which would qualify them for surgery in most hospitals improved greatly with active conservative treatment. Although the patients had greater faith in the SHAMIA before treatment, the SYMIA treatment was superior in most outcomes


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 12 - 12
17 Nov 2023
Cowan G Hamilton D
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Abstract. Objective. Meta-analysis of clinical trials highlights that non-operative management of degenerative knee meniscal tears is as effective as surgical management. Surgical guidelines though support arthroscopic partial meniscectomy which remains common in NHS practice. Physiotherapists are playing an increasing role in triage of such patients though it is unclear how this influences clinical management and patient outcomes. Methods. A 1-year cohort (July 2019–June 2020) of patients presenting with MRI confirmed degenerative meniscal tears to a regional orthopaedic referral centre (3× ESP physiotherapists) was identified. Initial clinical management was obtained from medical records alongside subsequent secondary care management and routinely collected outcome scores in the following 2-years. Management options included referral for surgery, conservative (steroid injection and rehabilitation), and no active treatment. Outcome scores collected at 1- and 2-years included the Forgotten Joint Score-12 (FJS-12) questionnaire and 0–10 numerical rating scales for worst and average pain. Treatment allocation is presented as absolute and proportional figures. Change in outcomes across the cohort was evaluated with repeated measures ANOVA, with Bonferroni correction for multiple testing, and post-hoc Tukey pair-wise comparisons. As treatment decision is discrete, no direct contrast is made between outcomes of differing interventions but additional explorative outcome change over time evaluated by group. Significance was accepted at p=0.05 and effect size as per Cohen's values. Results. 81 patients, 50 (61.7%) male, mean age 46.5 years (SD13.13) presented in the study timeframe. 32 (40.3%) received conservative management and 49 (59.7%) were listed for surgery. Six (18.8%) of the 32 underwent subsequent surgery and nine of the 49 (18.4%) patients switched from planned surgery to receiving non-operative care. Two post-operative complications were noted, one cerebrovascular accident and one deep vein thrombosis. The cohort improved over the course of 2-years in all outcome measures with improved mean FJS-12 (34.36 points), mean worst pain (3.74 points) average pain (2.42 points) scores. Overall change (all patients) was statistically significant for all outcomes (p<0.001), with sequential year-on-year change also significant (p<0.001). Effect size of these changes were large with all Cohen-d values over 1. Controlling for age and BMI, males reported superior change in FJS-12 (p=0.04) but worse pain outcomes (p<0.03). Further explorative analysis highlighted positive outcomes across all surgical, conservative and no active treatment groups (p<0.05). The 15 (18%) patients that switched between surgical and non-surgical management also reported positive outcome scores (p<0.05). Conclusion(s). In a regional specialist physiotherapy-led soft tissue knee clinic around 60% of degenerative meniscal tears assessed were referred for surgery. Over 2-years, surgical, non-operative and no treatment management approaches in this cohort all resulted in clinical improvement suggesting that no single strategy is effective in directly treating the meniscal pathology, and that perhaps none do. Clinical intervention rather is directed at individual symptom management based on clinical preferences. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_5 | Pages 4 - 4
23 Apr 2024
Turley S Booth C Gately S McMahon L Donnelly T Ward A
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The requirement for the peer support groups were born out of concern for the psychological wellbeing of the paediatric patients and to assess if this would improve their wellbeing during their treatment. Groupwork is a method of Social Work which is recognised as a powerful tool to allow people meet their need for belonging while also creating the forum for group members to empower one another. Social Work meet with all paediatric patients attending the limb reconstruction service in the hospital. The focus of the Medical Social Worker (MSW) is to provide practical and emotional support to the patient and their parent/guardian regarding coping with the frame. Some of the challenges identified through this direct work include patient's struggling with the appearance of the frame and allowing peers to see the frame. The peer support group aims to offer its attendees the opportunities to engage with fellow paediatric patients in the same position. It allowed them to visually identify with one another. We wanted to create a safe space to discuss the emotional impact of treatment and the frames. It normalises the common problems paediatric patients face during treatment. We assisted our participants to identify new coping techniques and actions they can take to make their journey through limb reconstruction treatment more manageable. Finally, we aimed to offer the parents space to similarly seek peer support with regard to caring for a child in treatment. All paediatric patients were under the care of the Paediatric Orthopaedic Consultant and were actively engaging with the limb reconstruction multi-disciplinary team (MDT). The patient selection was completed by the MDT; based on age, required to be in active treatment, or their frames were removed within one month prior to the group's commencement. Qualitative data was collected through written questionnaires and reflection from participants in MSW sessions. We also used observational data from direct verbal feedback from the MDT. In the first group, parents gave feedback due to participants age and completed written feedback forms. For our second group, initial feedback was collated from the participants after the first session to get an understanding of group expectations. Upon completion, we collected data from both the participants and the parents. Qualitative and scaling questions gathered feedback on their experience of participating in the group. We held two peer support groups in 2022:One group for patients aged between 3–6 years in January 2022 across two sessions, which was attended by four patients. The second group for young teenage patients aged between 11–15 years in April 2022 across four sessions, which was attended by five patients. The written feedback received from group one focused on eliciting the participant's experience of the groupwork. 100% of participants identified the shared experience as the main benefit of the groupwork. 100% of participants agreed they would attend a peer support group again, and no participant had suggestions for improvement to the group. Feedback did indicate that group work at the beginning of treatment could be more beneficial. In relation to the second group, 60% of the paediatric patients and their parents returned the questionnaires. All of the parent's feedback identified that it was beneficial for their child to meet peers in a similar situation. They agreed that it was beneficial to meet other parents, so they could get support and advice from one another. On a scale between 1 and 5, 5 being the highest score, the participants scored high on the group work meeting their expectations, enjoyment of the sessions, and the group work was a beneficial aspect of their treatment. All respondents would strongly recommend groupwork to other paediatric patients attending for limb reconstruction treatment. Overall, the MDT limb reconstruction team, found the peer support group work of great benefit to the participants and their parents. The MSW team identified that during a period on the limb reconstruction team, when a high number of patients were in active treatment, the workload of the MSW also increased reflecting this activity. Common issues and concerns were raised directly to MSW (particularly from group two) regarding numerous difficulties they experienced trying to cope with the frame. The group work facilitators created a space where the participants could get peer support, share issues caused by the frame, hear directly from others, and that they too experience similar feelings or issues. Collectively, they identified ways of coping and promoting their own wellbeing while in treatment. The participants in group two, subsequently created a group on social media, to be able to continue their newly formed friendships and to continue to update one another on their treatment journeys. The participants self-requested another group in the future. This was facilitated in November 2023, the facilitators sought more feedback from all participants and their parents after this session. These findings will contribute towards the analysis for the presentation. Peer support groupwork was presented at the hospital's foundation day and has been well received by senior management in the hospital, as a positive addition to the limb reconstruction service. The focus of the MDT in 2024, is to further develop and facilitate more peer support groups for our paediatric patients


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 185 - 185
1 May 2012
W. DF M. RL B. IE S. DB F. M T. JB M. H T. W A. KK A. GGT
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Hypothesis. Pre-specified pooling of data from the four phase III RECORD studies was conducted to determine whether rivaroxaban significantly reduced the less-frequent clinical endpoint of symptomatic venous thromboembolism (VTE) and all-cause mortality after total hip or knee arthroplasty (THA or TKA, respectively), compared with standard North American and European enoxaparin regimens. Methods and analysis. Patients (n=12,729) received rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily (RECORD1-3) or 30 mg 12-hourly (RECORD4). Thromboprophylaxis was administered for 31-39 days (RECORD1; THA) or 10-14 days (RECORD3 and 4; TKA). RECORD2 (THA) compared 31-39 days' rivaroxaban with 10-14 days' enoxaparin followed by placebo. The pre-specified primary efficacy endpoint in the pooled analysis (composite of symptomatic VTE and all-cause mortality) and adjudicated bleeding events were analysed in the day 12±2 active treatment pool, when all patients had received active drug, and total treatment duration pool, where subgroup analyses were performed. Results. In the day 12±2 active treatment pool, the primary efficacy endpoint occurred in 0.5% of patients receiving rivaroxaban versus 1.0% of patients receiving enoxaparin (p=0.001). Major bleeding occurred in 0.3% versus 0.2% patients respectively (p=0.18) and major plus clinically relevant non-major bleeding occurred in 2.9% versus 2.5% patients respectively (p=0.19). In the total treatment duration pool, rivaroxaban significantly reduced the primary efficacy endpoint compared with enoxaparin regimens 0.6% versus 1.3% patients (p< 0.001) with similar rates of major bleeding. Over the total treatment period, rivaroxaban consistently reduced the primary efficacy endpoint across the pre-specified subgroups (age, gender, body weight, creatinine clearance). Conclusion. Rivaroxaban significantly reduced the composite of clinically important symptomatic VTE and all-cause mortality after THA or TKA compared with subcutaneous enoxaparin regimens in the direct comparison day 12±2 active treatment pool, with no significant differences in bleeding events. These results suggest a positive benefit-risk profile for oral, once-daily rivaroxaban


Bone & Joint Open
Vol. 5, Issue 5 | Pages 435 - 443
23 May 2024
Tadross D McGrory C Greig J Townsend R Chiverton N Highland A Breakwell L Cole AA

Aims

Gram-negative infections are associated with comorbid patients, but outcomes are less well understood. This study reviewed diagnosis, management, and treatment for a cohort treated in a tertiary spinal centre.

Methods

A retrospective review was performed of all gram-negative spinal infections (n = 32; median age 71 years; interquartile range 60 to 78), excluding surgical site infections, at a single centre between 2015 to 2020 with two- to six-year follow-up. Information regarding organism identification, antibiotic regime, and treatment outcomes (including clinical, radiological, and biochemical) were collected from clinical notes.


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

Aims

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

Methods

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


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 47 - 47
1 Jun 2018
Berend K
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Introduction. Total joint arthroplasty is associated with substantial blood loss as well as changes in basic metabolic labs. Routinely patients receive multiple post-operative blood draws for measuring hematocrit, hemoglobin (H&H), and basic metabolic panels (BMP). Based on a multimodal approach to blood conservation and pre-operative optimization, we questioned the need to check daily labs on our inpatient primary total hip and knee patients. The purpose of this study was to identify risk factors for transfusion and metabolic abnormalities requiring treatment in an attempt to reduce the number of post-operative blood draws and labs. Methods. We retrospectively reviewed all 1134 patients who underwent primary total hip (THA) or total knee arthroplasty (TKA) from July 2016 to March 2017 in our inpatient hospital setting. There were 733 TKA and 401 THA. Pre- and post-operative lab values were reviewed and correlated with transfusion and medical treatments. Results. Twelve patients received a post-operative transfusion (1.1%). In TKA patients 2 of 733 (0.2%) were transfused while in THA patients 10 of 401 (2.4%) were transfused. Of the 12 patients receiving transfusions 11 were females, and in all 12 the pre-operative hemoglobin was less than 13. For the overall series of 1134 patients, 176 (15.5%) required potassium chloride supplementation based on BMP. Only patients with pre-existing renal disease or diuretic treatment received potassium chloride supplementation. Conclusions. Based on our findings, only patients with pre-operative hemoglobin less than 13 require post-operative H&H. Additionally, only patients with low pre-operative potassium, history of renal disease, or active treatment with a diuretic require post-operative BMP


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 14 - 14
1 Feb 2018
Alreni A McLean S Demack S Harrop D Kilner K
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Background and objectives. Numerous approaches are recommended for the management of non-specific neck pain (NS-NP). However, the extent to which approaches are used is unclear. This survey investigated current UK physiotherapists' measurement and management of patients with NS-NP. Methods and results. Physiotherapists were invited to participate in an online survey if they were practicing in the UK and had experience of managing NS-NP. 2101 responses were received. Analysis of the results indicated the overall popularity of active treatment approaches with 84% and 61% of respondents employing exercise and patient education respectively. 48% of respondents reported using a multimodal approach (that is, combination of exercise and manual therapy with/without patient education). Over a third of respondents reported not using outcome measures (OMs) for NS-NP. Of the two-thirds who reported using OMs, the majority reported using pain and range of motion measures. Physical and functional limitations, psychological distress, and quality of life constructs, which are frequently associated with NS-NP, were rarely measured. Conclusion. The active interventions most frequently used in the management of NS-NP were supported by moderate to strong evidence but a variety of other commonly used approaches have limited, unclear or no evidence of efficacy. Multimodal treatment approaches that are supported by strong evidence of efficacy are less commonly used. Physiotherapists in the UK are inadequately evaluating NS-NP. Research and guidelines are needed to reduce the use of ineffective interventions, promote the use of multimodal care and develop high quality outcome measures that are relevant and feasible for use in clinical practice. Keywords. Health, survey, neck pain, non-specific, rehabilitation. Conflicts of interest: None. Sources of funding: None


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 5 - 5
1 Feb 2018
Braeuninger-Weimer K Anjarwalla N Weerasinghe T Lunn M Das S Mohammed H Pincus T
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Background. Previous research in people with musculoskeletal low back pain (MLBP) in primary care shows that a reliable and valid measure of consultation-based reassurance enables testing reassurance against patient' outcomes. Little is known about the role of reassurance in people with MLBP consulting spinal surgeons, especially in cases where surgeons recommend not to have surgery. There might be several reasons to exclude surgery as a treatment option, that range from positive messages about symptoms resolving to negative messages, suggesting that all reasonable avenue of treatment have been exhausted. AIM to explore patient's experience of consultation-based reassurance in people with MLBP who have been recently advised not to have surgery. Methods. Semi-structured interviews were conducted with 30 low back pain patients who had recently consulted for spinal surgery and were advised that surgery is not indicated. Interview were audio recorded and transcribed, and then coded using NVIVO qualitative software and analysed using the Framework Analysis. Results. Most patients reported feeling dismissed and discouraged. They considered that consultants were better in relationship building and data gathering than in providing cognitive and generic reassurance. Major emerging themes included the complexity and confusion of their NHS journey, lack of continuity-of-care, lack of information for their condition and a sense of dismissal. Patients reported that they needed reassurance through clear explanations and discussion of pain management, but instead were discharged into a void. Conclusion. Effective communication with patients attending surgical settings to consult about their back pain is important, especially when no active treatment is being offered. No conflict of interest. Funded by a grant from EuroSpine awarded to Professor Tamar Pincus and carried out within the NHS


Bone & Joint Open
Vol. 3, Issue 8 | Pages 641 - 647
1 Aug 2022
Leighton PA Brealey SD Dias JJ

Aims

To explore individuals’ experience of a scaphoid waist fracture and its subsequent treatment.

Methods

A purposive sample was created, consisting of 49 participants in the Scaphoid Waist Internal Fixation for Fractures Trial of initial surgery compared with plaster cast treatment for fractures of the scaphoid waist. The majority of participants were male (35/49) and more younger participants (28/49 aged under 30 years) were included. Participants were interviewed six weeks or 52 weeks post-recruitment to the trial, or at both timepoints. Interviews were semistructured and analyzed inductively to generate cross-cutting themes that typify experience of the injury and views upon the treatment options.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 301 - 301
1 Mar 2004
Rompe J Eichhorn W Riedel C Meurer A Schoellner C Heine J
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Aims: Primary aim of this study was to evaluate the inßuence of simultaneous local anesthesia on the clinical outcome after repetitive low-energy extracorpreal shock wave therapy (ESWT) for chronic tennis elbow. Methods: 51 patients were treated in a randomized single-blind international multicenter trial with a parallel-group design and blinded independent observer to evaluate low-energy ESWT with local anesthesia versus placebo ESWT with local anesthesia for patients with a chronic tennis elbow at three-month follow-up. 85% of patients of the verum group did not achieve good/ excellent results in the Roles & Maudsley score, they were offered once again application of the identical active treatment concept, this time without local anesthesia. 80% of the patients of the placebo group did not achieve good/excellent results, they were offered crossover therapy, i.e. identical active treatment with local anesthesia. Results: Reception of active therapy without local anesthesia resulted in excellent or good outcomes in 80% of patients of the original verum group at three-month follow-up, while application of active therapy with local anesthesia lead to good outcomes in 27% of the original placebo group (p= 0.0092, power= 0.8). Conclusions: Local anesthesia has a negative inßuence on the clinical outcome after repetitive low-energy ESWT for chronic tennis elbow


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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_30 | Pages 3 - 3
1 Aug 2013
Watson D Russell D Hodgeson K Rymaszewski L
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Intervention is rare following minimally displaced radial head fractures or positive elbow ‘fat pad’ signs. A pilot study (n=20) found no patient required active treatment after discharge following their first fracture clinic visit. We therefore initiated routine discharge from A&E with an advice sheet, and an ‘open-door policy’ if patients failed to progress. 51 patients were managed by A&E according to this protocol over a six-month period. A standardised assessment of symptoms, satisfaction and functional limitation was completed for 24 patients by phone; average time to follow-up 4.2 months (range 2–9 months). Fourteen (58.4%) reported no pain. The 10 patients (41.6%) with on-going pain reported a median visual analogue score (VAS 0–10) of 0.7 (0–4) at rest, 0.25 (0–4) at night, 3.0 (0–10) carrying heavy objects and 2.75 (0–10) during repetitive movement. 4 of 24 (16.7%) reported minor functional impairment. 3 of 24 (12.5%) patients requested orthopaedic review, but all were satisfied with outcome, seeking reassurance and discharged without any intervention. 3 of 24 (12.5%) were unhappy with their progress, but all had suffered from chronic pain or psychological conditions predating their injury. When offered further review, none of these patients accepted. 22 (91%) were satisfied with their treatment and 23 (95.8%) returned to work and hobbies. This data suggests routine discharge from A&E with advice does not compromise care, as no intervention is usually required beyond advice. These findings have obvious positive clinical and financial implications in streamlining clinical workload


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 6 - 6
1 Jan 2013
Mansell G Hill J Vowles K van der Windt D
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Introduction. The STarT Back trial demonstrated that targeting back pain treatment according to patient prognosis (low, medium or high-risk subgroups) is effective. However, the mechanisms leading to these improved treatment outcomes remain unknown. This study aimed to identify which psychological variables included in the study were mediating treatment outcome for all patients and within the low, medium and high-risk subgroups. Methods. Secondary analysis was conducted on 466 patients randomised to the active treatment arm with 4-month follow-up available. Psychological variables included depression (HADs), fear (TSK), catastrophising (PCS), bothersomeness and illness perception constructs (IPQ brief) e.g. personal control. Treatment outcome was characterised using change in disability score (RMDQ) at 4-months. Residualised change scores were calculated for each variable and Pearson's correlations were calculated overall and at the subgroup level to determine potential mediating variables for disability improvement. Results. Overall, correlations with RMDQ change were .62 for change in bothersomeness, .56 for change in catastrophising, .51 for change in fear, .48 for change in anxiety, .58 for change in depression, −.32 for change in personal control and .40 for change in symptom identity. The strength of correlation generally increased from low to high-risk subgroups, e.g. bothersomeness (low=.54, high=.70). However, the predominant variables mediating treatment outcome were common across risk-groups. Conclusion. The psychological variables which were highly correlated with improvements in disability were bothersomeness, depression and catastrophising. This finding was consistent across low, medium and high-risk subgroups. This study is ongoing and further mediation analysis using structural equation modelling is in progress. Conflicts of Interest. None. Source of Funding. NIHR Spinal Pain Programme grant


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 110 - 110
1 Apr 2012
Young Y Gibson A Lutton C Mackay-Sim A Mehta S Williams R Goss B
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AO Spine Reference Centre & Institute of Health & Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. Traumatic spinal cord injury (SCI) is a devastating condition with no curative therapy. Pro-inflammatory therapy has been suggested recently to try and reduce the inhibitory glial scar and promote neural regeneration and healing. The aim of this study is to investigate the potential of sustained delivery of angiogenic/pro-inflammatory growth factors to reduce the secondary degeneration after spinal cord injury. Adult male Wistar Kyoto rats (200-300g; 12-16weeks old) were subjected to cord hemisections via a T10 laminectomy. Animals were randomised to treatment or control groups after the spinal cord injury had been induced. Treatment consisted of implantation of a mini-osmotic pump capable of delivering 5 micrograms vascular endothelial growth factor (VEGF) and 5 micrograms platelet-derived growth factor (PDGF), via a catheter, to the site of the lesion, over 7 days(n=6). Control animals were subjected to either cord lesion only (n=6) or lesion plus mini-pump delivering PBS (phosphate-buffered saline) solution (n=6). Rats were sacrificed at one month and the spinal cords were harvested and examined by immunohistology, using anti-neurofilament-200 and anti-Glial Acidic Fibrillary Acidic Protein (GFAP) antibodies. RESULTS: Active treatment spinal cords showed a higher level with aboration of the axonal filament through the defect and more dense neurofilament-200 staining at the lesion site compared to both control groups. The treatment also showed the elevated presence of activated microglia in the lesion, whilst distal to the lesion the microglia and astrocytes retained an unreactive phenotype. Pro-inflammatory therapy in the rat spinal cord-injury model showed favourable histological findings after sustained delivery of PDGF and VEGF


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 482 - 482
1 Sep 2012
Popa I Negoescu D Poenaru D Faur C Florescu S
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BACKGROUND CONTEXT. Osteoporosis causes decreased bone mineral density, which predisposes to fragility fractures. Low-energy vertebral compression fractures are the most common type of osteoporotic fragility fracture. Prior studies have shown that only one-quarter of patients diagnosed with an osteoporotic fracture are referred or treated for osteoporosis. PURPOSE. To identify the rate of recurrent fractures after vertebroplasty and after the conservative treatment for patients aged 50 years and older who sustained low impact vertebral compressions fractures over a 6-month period. STUDY DESIGNED/SETTING. Prospective study. PATIENT SAMPLE. The sample included patients 50 years or older who had a low-energy vertebral compression fracture. The patients were divided into two groups: first group (n=24) - patients teated by vertebroplasty and the second group (n=34) - patients treated conservatory. There was no significant difference among the groups in terms of the vertebral levels or BMD. METHODS. Patients records were reviewed for fracture recurrence and in the same time we examined medical records for osteoporotic medication prescriptions, refferals to endocrinology and to dual-energy X-ray absorptiometry (DEXA) scans. RESULTS. Confounding factors of age at the procedure, sex and chronic steroids use were considered and found to have no statistically significant difference between the two groups and between those with fracture recurrence and those without fracture recurrence. Four vertebroplasty procedure resulted in a recurrent fracture within the first 6 months. In the patient group treated conservatory 8 patients sustained recurrent fractures. Patients with recurrent vertebral fracture didn't receive active osteoporosis treatment. Within 6 months after the fracture only 21% of patients were receiving active osteoporosis treatment. CONCLUSIONS. The incidence of recurrent fracture after vertebroplasty or after conservative treatment is substantial but have no statistically significant difference between the two groups. We consider that the recurrence rate is not related with the surgical intervention but is the result of natural history of the patient's osteoporosis because the patients do not understand the importance of initiating active therapeutic intervention for osteoporosis recommended by physicians