Introduction: Physical activity is a major outcome in total hip arthroplasty (THA) and discharge criterion. Increasing immediate post-op activity may accelerate discharge, enable fast track surgery and improve general rehabilitation. Preliminary evidence (O'Halloran P.D. et al. 2015) shows that feedback via motivational interviewing can result in clinically meaningful improvements of physical activity. It was the aim of this study to use wearable sensor activity monitors to provide and study the effect of biofeedback on THA patients' activity levels. It was hypothesized that biofeedback would increase in-hospital and post-discharge activity versus controls.

Methods: In this pilot study, 18 patients with osteoarthritis receiving elective primary THA followed by a rapid recovery protocol with discharge on day 3 after surgery (day 0) were randomized to the feedback group (n=9, M/F: 4:5, age 63.3 ± 5.9 years, BMI 26.9 ± 5.1) or a non-feedback control group (n=9, M/F: 0:9, age 66.9 ± 5.1 years, BMI 27.1 ± 4.0). Physical activity was measured using a wearable sensor and parameters (Time-on-Feet (ToF), steps, sit-stand-transfers (SST), mean cadence (steps/min)) were calculated using a previously validated algorithms (Matlab). For the in-hospital period data was calculated twice daily (am, ca. 8–13:00h and pm, ca. 13–20:00h) of day 1 (D1) and 2 (D2). The feedback group had parameters reported back twice (morning, lunch) using bar charts comparing visually and numerically their values (without motivational instructions) to a previously measured reference group (n=40, age 71 ±7 years, M:F 16:24) of a conventional discharge protocol (day 4/5). Activity measures continued from discharge (D3) until day 5 (D5) at home.

Results: Randomization resulted in matched groups regarding age and BMI, but not gender. The first post-op activity assessment (D1am) was identical between groups. Also thereafter similar values with no significant differences in any parameter were seen, e.g. the time-on-feet at D2PM was 59.2 ±31.7min (feedback) versus 62.9 ±39.2min (controls). Also on the day of discharge and beyond, no effect from the in-hospital feedback was measured. For both groups the course of activity recovery showed a distinct drop on day 4 following a highly active day of discharge (D3). On day 5, activity levels only recovered partially. For both groups, all quantitative activity parameters were significantly higher than the reference values used for feedback. Only cadence as a qualitative measure was the same like reference values.

Discussion: Biofeedback using activity values from a body-worn monitor did not increase in-hospital or immediate post-op home activity levels compared to a control group when using the investigated feedback protocol. In general, while the day of discharge steeply boosts patient activity, the day after at home results in an activity drop to near in-patient levels before discharge. In a fast track surgery protocol, it may be of value to avoid this drop via patient education or home physiotherapy. Biofeedback using activity monitors to increase immediate post-op activity for fast track surgery or improved recovery may only be effective when feedback goals are set higher, are personalised or have additional motivational context.

Glutamate regulates the expression of apoptosis-related genes and triggers the apoptosis of fibroblasts in rotator cuff tendons. Subacromial bursitis is always accompanied by symptomatic rotator cuff tear (RCT). However, no study has been reported on the presence of glutamate in subacromial bursa and on its involvement of shoulder pain in patients who had RCT. The purposes of this study were to determine whether the glutamate expression in subacromial bursa is associated with the presence of RCT and with the severity of shoulder pain accompanying RCT. Subacromial bursal tissues were harvested from patients who underwent arthroscopic rotator cuff tendon repair or glenoid labral repair with intact rotator cuff tendon. Glutamate tissue concentrations were measured, using a glutamate assay kit. Expressions of glutamate and its receptors in subacromial bursae were histologically determined. The sizes of RCT were determined by arthroscopic findings, using the DeOrio and Cofield classification. The severity of shoulder pain was determined, using visual analog scale (VAS). Any associations between glutamate concentrations and the size of RCT were evaluated, using logistic regression analysis. The correlation between glutamate concentrations and the severity of pain was determined, using the Pearson correlation coefficient. Differences with a probability <0.05 were considered statistically significant. Glutamate concentrations showed significant differences between the torn tendon group and the intact tendon group (P = 0.009). Concentrations of glutamate significantly increased according to increases in tear size (P < 0.001). In histological studies, the expressions of glutamate and of its ionotropic and metabotropic receptors have been confirmed in subacromial bursa. Glutamate concentrations were significantly correlated with pain on VAS (Rho=0.56 and P =0.01). The expression of glutamate in subacromial bursa is significantly associated with the presence of RCT and significantly correlated with its accompanying shoulder pain. Acknowledgements: This research was supported by the Basic Science Research Program, through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (NRF-2015R1D1A3A01018955 and 2017R1D1A1B03035232)

Critical shoulder angle (CSA), lateral acromial angle (LAA), and acromion index (AI) are common radiologic parameters used to distinguish between patients with rotator cuff tears (RCT) and those with an intact rotator cuff. This study aims to assess the predictive power of these parameters in degenerative RCT. This retrospective study included data from 92 patients who were divided into two groups: the RCT group, which included 47 patients with degenerative full-thickness supraspinatus tendon tears, and a control group of 45 subjects without tears. CSA, AI, and LAA measurements from standardized true anteroposterior radiographs were independently derived and analyzed by two orthopedic surgeons. Receiver operating characteristic (ROC) analyses were performed to determine the cutoff values. No significant differences were found between patients in the RCT and control groups in age (p = 0.079), gender (p = 0.804), or injury side (p = 0.552). Excellent inter-observer reliability was seen for CSA, LAA, and AI values. Mean CSA (38.1°) and AI (0.72) values were significantly larger in the RCT group than in the control group (34.56° and 0.67°, respectively, p < 0.001) with no significant difference between groups for LAA (RCT, 77.99° vs. control, 79.82°; p = 0.056). ROC analysis yielded an area under the curve (AUC) of 0.815 for CSA with a cutoff value of 37.95°, and CSA was found to be the strongest predictor of the presence of a RCT, followed by AI with an AUC of 0.783 and a cutoff value of 0.705. We conclude that CSA and AI may be useful predictive factors for degenerative RCT in the Turkish population

The function of the upper extremity is highly dependent on correlated motion of the shoulder. The shoulder can be affected by several diseases. The most common are: rotator cuff tear (RCT), shoulder instability, shoulder osteoarthritis and fractures. Rotator cuff disease is a common disorder. It has a high prevalence rate, causing high direct and indirect costs. The appropriate treatment for RCT is debated. The American Academy Orthopaedic Surgeons guidelines state that surgical repair is an option for patients with chronic, symptomatic full-thickness RCT, but the quality of evidence is unconvincing. Thus, the AAOS recommendations are inconclusive. We are performing a randomized controlled trial to compare surgical and conservative treatment of RCT, in term of functional outcomes, rotator cuff integrity, muscle atrophy and fatty degeneration. Shoulder instability occurs when the head of the upper arm bone is forced out of the shoulder socket. Shoulder instabilities have been classified according to the etiology, the direction of instability, or on combinations thereof. The Thomas and Matsen classification, which is currently the most commonly utilized classification, divides shoulder instability events into the traumatic, unidirectional, Bankart lesion, and surgery (TUBS) and the atraumatic, multidirectional, bilateral, rehabilitation, and capsular shift (AMBRI) categories. The acquired instability overstress surgery (AIOS) category was then added. Surgical procedures for shoulder instability includes arthroscopic capsuloplasty, remplissage, bone block procedure or Latarjet procedure. Reverse total shoulder arthroplasty (RTSA) represents a good solution for the management of patients with osteoarthritis or fracture of the proximal humerus, with associated severe osteoporosis and RC dysfunction

The principal of “function priority, early rehabilitation, and return to sports” is now the goal for sports injury rehabilitation. Neuromuscular electrical stimulation for anterior cruciate ligament (ACL) reconstruction is a rising procedure for early rehabilitation. This paper systematically assessed the effects of neuromuscular electrical stimulation on postoperative ACL reconstruction to provide guidance for physiotherapist and patient when designing a suitable rehabilitation protocol. To evaluate the interventional outcomes of neuromuscular electrical stimulation following ACL reconstruction, we searched PubMed, EMbase, the Cochrane Library, Web of Science and CNKI to collect all randomized controlled trials (RCTs) comparing the effects with neuromuscular electrical stimulation and without intervention on rehabilitation after ACL reconstruction up to January 30, 2022. Two investigators independently performed literature screening, data extraction, bias assessment of risk, and used RevMan 5.3 software to conduct a meta-analysis. A total of six RCTs were included, and the results showed that the use of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction significantly improved the International Knee Documentation Committee (IKDC) scores (MD 6.33, 95% CI [-0.43, 12.22]; I2 = 66%; p = 0.040), the Lysholm score (MD 7.94, 95% CI [6.49, 9.39]; I2 = 89%; p < 0.001), and the range of motion (ROM) (MD 9.99, 95% CI [7.97, 12.02]; I2 = 81%; p < 0.001) in the knees when compared to the control group without using neuromuscular electrical stimulation. Existing evidence show that neuromuscular electrical stimulation is beneficial for early rehabilitation after ACL reconstruction. The use of neuromuscular electrical stimulation is encouraged in the design of rehabilitation protocol. However, due to the limited number of RCT studies and the small sample size, further multi-center RCTs with more participants are needed for a higher-level evidence

Introduction. Approximately 20-25% of patients having joint replacement in the UK have moderate-severe frailty. Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively with exercise and protein supplementation could improve post-operative outcomes. Prior to conducting a randomised controlled trial (RCT), a feasibility study was necessary to inform trial design and delivery. Method. We conducted a randomised feasibility study with embedded qualitative work. Patients aged ≥65 years, frail and undergoing THR or TKR were recruited from three UK hospitals. Participants were randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group had a 1:1 appointment with a physiotherapist and were provided with a home-based, tailored daily exercise programme and a daily protein supplement for 12 weeks before their operation, supported by six telephone calls from a physiotherapist. Questionnaires were administered at baseline and 12 weeks after randomisation. Interviews were conducted with 19 patients. Feasibility outcomes were eligibility and recruitment rates, intervention adherence, and acceptability of the trial and the intervention. Result. 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% at 12 weeks. The 12-week follow-up questionnaire was returned by 84% of participants who were sent a questionnaire. Interviews found that the trial and intervention were generally acceptable, but areas of potential improvements were identified. Conclusion. This study demonstrated that a larger study is possible and has identified improvements to optimise the design of a RCT

Patients with knee prosthetic joint infection (PJI) frequently receive one- or two-stage revision. To explore the feasibility of a randomised controlled trial (RCT) comparing methods, we analysed a UK registry, interviewed patients and surgeons, systematically reviewed literature, held a consensus meeting, and assessed progress of an RCT in hip PJI. In 2014, in England and Wales, knee PJI was treated with one- or two-stage procedures in 19% and 71% of patients respectively. Between 2007 and 2014, use of one-stage procedures doubled and, in major centres, up to 42% of treatments were one-stage. We conducted in-depth interviews with 16 patients with knee PJI and 11 surgeons performing one- or two-stage revision. Patients considered randomisation acceptable with appropriate counselling and, depending on infecting organisms and health status, surgeons would randomise treatments. In meta-analysis, two-year re-infection rates in 10 one-stage series (423 patients) and 108 two-stage series (5,129 patients) were 7.6% (95%CI 3.4,13.1) and 8.8% (7.2,10.6) respectively. In a series of patients with knee PJI, surgeons from 2 major centres considered 6/15 patients eligible for either treatment, with 4 more potentially eligible after treatment of soft tissue infection. In an ongoing RCT of surgical treatment of hip PJI, 116 patients have been randomised at 14 centres in 3 years. Randomising patients with PJI is feasible but, as knee PJI is uncommon, a multicentre RCT would be required. Based on WOMAC score outcome and appropriate assumptions on eligibility and acceptability, 170 patients would need to be randomised over 4 years at 14 major centres

Introduction and Objective. Only few studies have investigated the outcome of exercises in patients with glenohumeral osteoarthritis (OA) or rotator cuff tear arthropathy (CTA), and furthermore often excluded patients with a severe degree of OA. Several studies including a Cochrane review have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments. Before initiation of such a trial, the feasibility of progressive shoulder exercises (PSE) in patients, who are eligible for shoulder arthroplasty should be investigated. The aim was to investigate whether 12 weeks of PSE is feasible in patients with OA or CTA eligible for shoulder arthroplasty. Moreover, to report changes in shoulder function and range of motion (ROM) following the exercise program. Materials and Methods. Eighteen patients (11 women, 14 OA), mean age 70 years (range 57–80), performed 12 weeks of PSE with 1 weekly physiotherapist-supervised and 2 weekly home-based sessions. Feasibility was measured by drop-out rate, adverse events, pain and adherence to PSE. Patients completed Western Ontario Osteoarthritis of the Shoulder (WOOS) score and Disabilities of the Arm, Shoulder and Hand (DASH). Results. Two patients dropped out and no adverse events were observed. Sixteen patients (89%) had high adherence to the physiotherapist-supervised sessions. Acceptable pain levels were reported. WOOS improved mean 23 points (95%CI:13;33), and DASH improved mean 13 points (95%CI:6;19). Conclusions. PSE is feasible, safe and may improve shoulder pain, function and ROM in patients with OA or CTA eligible for shoulder arthroplasty. PSE is a feasible treatment that may be compared with arthroplasty in a RCT setting

Improved understanding of the biomechanics and biology of rotator cuff tendons (RCT) may help reduce high re-rupture rates following repairs, particularly amongst larger tears. This study aims to use novel methods for quantitatively determining differences in the mechanical and thermal properties of intact healthy RCTs compared to torn ‘diseased’ tendons. A common problem in the mechanical testing of small tendon samples is that stress risers at the clamp-tendon interface can obscure measurements. As the shoulder is subject to shear, tension and compression, we developed a novel solution using Dynamic Shear Analysis (DSA), a form of rheology which studies material deformation. As collagen is the main component of RCT, the structure and mechanical properties may be affected by collagen conformational changes. Both dermis and rat tail tendon with increased collagen cross-linking exhibit stronger mechanical properties. Thermal changes detected by differential scanning calorimetry (DSC) can help to quantify collagen structural differences in torn RCT, and has been previously used to study muscle, cartilage and vertebral discs. There were 79 tears (mean age 65.2 years), which were classified according to the size of the tear as small, medium, large and massive. Two separate 3mm-sized biopsy samples were taken and subjected to DSA using oscillatory deformation under compression. The storage modulus (G') was calculated and used as an indicator of mechanical integrity. 18 control tendon specimens were obtained from patients aged between 22-89 years (mean age 58.8 years) during shoulder hemiarthroplasties and stabilisations. Additionally 7 normal, 7 small and 7 massive frozen specimens were thermally characterized. 3 samples per patient were heated between 20-80oC in hermetically sealed vessels. Useful thermal parameters were measured such as the melting temperature (TM) which apparently represents breaking of the amide-amide bonds and protein chains mobility, the denaturation temperature (TD) which supposedly corresponds to proteins falling out of solution and the denaturation enthalpy (ΔH) which reflects the relative amount of triple helical structure. Healthy tendons had a significantly higher modulus than torn tendons, indicating that torn tendons are mechanically weaker than normal tendons (p = 0.032). Normal tendons had significantly higher mean shear modulus than tendons with small and massive tears (p<0.01). Overall there was a negative correlation between moduli and severity of tendon tear (r = −0.698, p=0.189). The moduli did not significantly correlate with age, sex, hand dominance, or length of preservation in formalin. Massive RCT tears had significantly higher TM and TD when compared to normal RCT (p < 0.05), unlike small RCT tears. No significant difference was detected between the denaturation enthalpy of the different RCT groups. This case control study has demonstrated that normal RCTs have a significantly higher modulus than torn tendons, indicating that torn tendons have less mechanical integrity. Our study further demonstrated a trend between increasing tear size and decreasing mechanical integrity. This study has also demonstrated differences in some of the thermal properties of normal and torn RCTs. These are likely due to collagen structural changes. A decrease in the denaturation temperature of torn tendons, suggests that the material is intrinsically less stable. Torn tendons with reduced storage modulus and collagen integrity may be less able to withstand mechanical loads following repair. This pilot study provides some preliminary insight into the mechanisms that may contribute to, or represent adaptations to high rates of failure of RCT repairs

Abstract. Objectives. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus NWB and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures. The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection, displacement of osteosynthesis, the full arc of ankle motion, RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the IWB group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021 with a similar result at three months. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a PE, both were randomised to NWB. Length of hospital stay was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusion. In this large multicentre RCT, we investigated WB following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome

Summary Statement. The peripheral neuronal phenotype is significantly altered in rotator cuff tendinopathy (RCT) with a clear upregulation of the Glutaminergic system being present in disease. Introduction. Shoulder pain is the third most frequent cause of chronic musculoskeletal pain in the community and is usually caused by rotator cuff tendinopathy (RCT). The central and peripheral nervous system play an important role in both tissue homoeostasis and tendon healing. The Glutaminergic system is of key importance in driving the peripheral and central neuronal changes which increase the body's sensitivity to pain (1, 2). No study to date has investigated the role of the glutaminergic system in human RCT. We hypothesised that the peripheral neuronal phenotype would be altered in RCT, and would vary according to disease stage as measured by size of tear. The term ‘peripheral neuronal phenotype’ is used to refer to refer to specific characteristics of the peripheral nervous system, neuronal mediators and the receptors for these mediators in peripheral tissue. Methods. Rotator cuff tendon specimens were obtained from 64 patients undergoing the surgical repair of rotator cuff tears. Control supraspinatus tendon was obtained from 10 patients undergoing surgery for anterior instability using an ultrasound guided biopsy technique. Patients with rotator cuff tears were divided into 2 groups: the small/medium group (≤ 3cm size) and the large/massive group (>3cm size). The tendon tissue was histologically stained using Haematoxylin and Eosin, and immunohistochemically stained with primary antibodies visualised using 3, 3′-diaminobenzidine (DAB). Image analysis was performed blindly by 2 observers using Image-J to quantify the amount of DAB positive staining. Data was non-parametric in distribution and Mann-Whitney U tests were carried out using SPSS with significance levels set at a minimum of p<0.025. Results. There were significant changes in the peripheral neuronal phenotype in RCT. The Glutaminergic system was significantly up-regulated with an increase in Glutamate and changes in several related receptors in disease versus control (p<0.01). The standard deviation in nuclei count and mean cell nuclear area were both increased in disease (p<0.01) compared to controls. Tendon vascularity and cell proliferation were reduced in disease vs control (p<0.01). There were no significant correlations between pain scores and the peripheral tissue markers. Discussion/Conclusion. The peripheral neuronal phenotype is significantly altered in rotator cuff tendinopathy (RCT) with clear changes in the Glutaminergic system in disease. These findings are novel and improve our understanding of pain and tissue healing in RCT, potentially providing novel therapeutic targets

Abstract. Background. Recruitment of patients to participate in Randomised control trials (RCTs) is a challenging task, especially for trauma trials in which the identification and recruitment are time-limited. Multiple strategies have been tried to improve the participation of doctors and recruitment of patients. Aim. To study the effect of a trainee advocate (trainee Principal investigator-tPI) on influencing junior doctors to take part in trials and its effect on recruitment for a multicenter prospective hip fracture RCT. Methods. A retrospective study comparing the number of junior doctors participating in trials and patients recruited before and after the introduction of informal tPI role at UHW Cardiff. Results. The target recruitment set by the central trial unit was 9/month. Excluding the research team, there were 6 trainees actively recruiting in the before period (Feb’19-July’19) in comparison with 12 in the after period (Sept’19-Feb’20). TPI had a direct influence on 9 of the 11 trainees to get involved in the trials by guidance and nudging. There were 105 eligible patients of which 62 were recruited (59% of eligible pts, 115% of target) in the before period in comparison with 102 recruited (76% of eligible pts, 189% of target) out of the 135 eligible patients in the after period. The proportion of recruitment done by the research team to that of trainees was 79%:21% in the before period in comparison with 30%:70% in the after period further improving to 15%:85% in the last 3 months. Conclusion. TPI can work alongside the PI and research team to be a valuable link person coordinating and engaging local trainees to take part in trials. This may be particularly beneficial in hospitals where there is no dedicated research team. TPI role could be formalized for many trials and can be used as a leadership & management potential building experience for trainees. 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

Background. Inpatient physiotherapy is routinely provided after total knee replacement (TKR) surgery to enhance recovery prior to discharge. However, the provision of outpatient physiotherapy is variable in the UK, and the longer-term benefits of outpatient physiotherapy are unclear. This study aimed to evaluate the feasibility of conducting a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of group-based outpatient physiotherapy after TKR. Methods. Patients listed for primary TKR were recruited prior to surgery. Patients who decided not to participate were asked about their reasons for non-participation. Patients were randomised to attend a newly developed post-operative physiotherapy class plus usual care or usual care alone. Patients allocated to the intervention group were invited to attend a weekly one-hour physiotherapy class, starting at 6 weeks after surgery and running over 6 consecutive weeks. The group classes were run by two physiotherapists within an outpatient gym, and involved task-orientated and individualised exercises. Classes ran on a rolling system, allowing new patients to join each week. Participants completed an evaluation questionnaire after the final class. Outcomes assessment was by questionnaire prior to surgery and 2 weeks, 3 months and 6 months after surgery. Outcomes related to function, pain, balance, self-efficacy, participation, quality of life and resource use. Results. 46/124 patients consented to participate (37% recruitment rate). Frequent reasons for non-participation were related to travelling distance, transportation, and time commitments. 17/23 patients randomised to the intervention group attended the exercise classes. Most (15) patients were very satisfied with the range of exercises on offer. The task-orientated and individual exercises were given average usefulness ratings of 9.6/10 and 9.5/10, respectively. Retention of participants was acceptable; 2 patients were withdrawn from the intervention group and 2 patients from the usual care group. Questionnaire return rates were high in the intervention group (91% at 6 months post-operative) but lower in the usual care group (65% at 6 months post-operative). Conclusion. This study highlights the importance of conducting feasibility work for a RCT. Collecting data on reasons for non-participation provided valuable information on barriers to participation in a trial with this population. The intervention was well attended, and feedback was positive. Questionnaire completion was lower in the usual care group, highlighting the need for additional strategies to improve data collection. Findings from this feasibility study have informed the design of a multi-centre RCT to evaluate the clinical and cost-effectiveness of a group-based outpatient physiotherapy intervention following TKR

Background. To aid recovery, rehabilitation is an important adjunct to surgery. Acknowledging the MRC framework for complex interventions we assessed the evidence-base for components of comprehensive rehabilitation in total hip (THR) and total knee replacement (TKR) pathways. Methods. We conducted systematic reviews and meta-analyses of randomised controlled trials (RCT) of pre-surgical exercise and education, occupational therapy and post-operative physiotherapy. In feasibility RCTs we explored acceptability of pain self-management and occupational therapy before THR, and physiotherapy after TKR. We searched trial registers for ongoing RCTs. Results. Pre-surgical interventions. Systematic review identified 38 interventions targeting physical function before THR and TKR. Interventions showed functional benefit compared with controls, standardised mean difference (SMD) 0.32 (95% CI 0.20, 0.44; p<0.00001). In 27 studies targeting in-hospital recovery, intervention patients had lower anxiety, SMD 0.38 (95% CI 0.13, 0.63; p=0.003), and earlier mobilisation by 4 hours (95% CI 0.04, 0.30; p=0.009). In 20 studies, interventions targeting long-term recovery showed no benefit for function or pain. We randomised 88 patients into a feasibility RCT of group-based pain self-management. Attendees were highly satisfied but participation was low. Pre-operatively, many patients may perceive that only surgery can treat their symptoms. Occupational therapy. Systematic review identified 7 small RCTs in THR. Function improved in patients receiving occupational therapy, SMD 0.40 (95%CI 0.09, 0.70; p=0.01) but this was not sustained post-surgery. In our feasibility study with 44 patients randomised to pre-operative provision of aids and appliances or usual care, the intervention was delivered successfully and acceptable to participants. We identified no ongoing studies. Post-discharge physiotherapy. Systematic review identified 7 small studies suggesting that physiotherapy after TKR gives functional benefit at 3–4 months, SMD 0.37 (95%CI 0.12, 0.62; p=0.004) but not at later follow up. As noted in a recent review in THR, quality of evidence was limited. Our feasibility study evaluated six weeks of group-based activity-orientated rehabilitation in 46 TKR patients. The programme was well-received and attendance good. A fully-powered RCT is underway. We identified two ongoing studies targeting patients at risk of, or with, poor recovery. Conclusion. The evidence-base for comprehensive rehabilitation in THR and TKR is growing. Pre-surgical interventions may be effective but, in isolation, not acceptable to many patients. Ongoing definitive trials in TKR physiotherapy will guide future care. Well-designed trials of physiotherapy after THR and occupational therapy are needed. Ultimately, rehabilitation interventions throughout THR and TKR pathways may provide optimal care but this will need appropriate evaluation

Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total hip replacement (THR). We assessed the effectiveness of LAI using a systematic review and a fully powered randomised controlled trial (RCT) with economic evaluation. We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving THR. Two reviewers screened abstracts, extracted data, and liaised with authors. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. If feasible, we conducted meta-analysis. In the APEX RCT, we randomised 322 patients awaiting THR to receive additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline) or standard anaesthesia alone. Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation. Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires. In the systematic review, we identified 13 studies (909 patients). Patients undergoing THR receiving LAI experienced greater pain reduction at 24 hours at rest, standardised mean difference (SMD) −0.61 (95%CI −1.05, −0.16; p=0.008) and at 48 hours during activity, SMD −0.43 (95%CI −0.78, −0.09; p=0.014). Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Long-term outcomes were not a focus of these studies. In the APEX RCT, pain levels in hospital were broadly similar between groups, probably due to patient-controlled analgesia. Opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. Patients receiving LAI were less likely to report severe pain at 12 months than those receiving standard care, odds ratio 10.2 (95%CI 2.1, 49.6; p=0.004). Complications were similar between groups. In the economic evaluation, LAI was associated with lower costs and greater cost-effectiveness than standard care. Using a £20,000 per QALY threshold, the incremental net monetary benefit was £1,125 (95%CI £183, £2,067) and the probability of being cost-effective was greater than 98 %. The evidence suggests that peri-operative LAI is a cost-effective intervention for reducing acute and chronic post-surgical pain after THR

Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total knee replacement (TKR). To assess the effectiveness of peri-operative LAI for pain management in patients receiving TKR we conducted a systematic review, fully powered randomised controlled trial (RCT) and economic evaluation. We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving TKR. Two reviewers screened abstracts and extracted data. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. Authors were contacted if required. When feasible, we conducted meta-analysis with studies analysed separately if a femoral nerve block (FNB) was provided. In the APEX RCT, we randomised 316 patients awaiting TKR to standard anaesthesia which included FNB, or to the same regimen with additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline). Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation. Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires. In the systematic review, 23 studies including 1,439 patients were identified. Compared with patients receiving no intervention, LAI reduced WOMAC-Pain by standardised mean difference (SMD) −0.40 (95%CI −0.58, −0.22; p<0.001) at 24 hours at rest and by SMD −0.27 (95%CI −0.50, −0.05; p=0.018) at 48 hours during activity. In three studies there was no difference in pain at any time point between randomised groups where all patients received FNB. Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Few studies reported long-term outcomes. In the APEX RCT, pain levels in hospital were broadly similar between groups. Overall opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. There were no differences in pain outcomes between groups at 12 months. In the economic evaluation, LAI was marginally associated with lower costs. Using the NICE £20,000 per QALY threshold, the incremental net monetary benefit was £264 (95%CI, −£710, £1,238) and the probability of being cost-effective was 62%. Although LAI appeared to have some benefit for reduced pain in hospital after TKR there was no evidence of pain control additional to that provided by femoral nerve block, however it would be cost-effective at the current NICE thresholds

The objective of this trial was to investigate the efficacy of a Comfrey root extract cream in patients with acute upper or lower back pain. The study was conducted as a double-blind, multi-centre, parallel group design RCT over a period of 5 ± 1 days. The patients (n=120, mean age 36.9 years, 46.7 % female) were treated three times a day, 4 g cream per application. The trial included four visits. The primary efficacy variable was the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at visits 1 to 4. Among the secondary objectives were back pain at rest (VAS), pressure algometry (pain-time curve; AUC over 5 days), global assessment of efficacy by the patient and investigator, and functional impairment measured with the Oswestry Disability Index. There was a significant treatment difference between verum and placebo. In the course of the trial the primary variable decreased on average (median) about 95,2 % in the Comfrey extract group and 37.8 % in the placebo group. The results separated by pain location show an equivalent effect of comfrey extract: Regarding pain at rest, in lower back pain a reduction of 98% were observed, in upper back pain 96.9%. The results of this RCT were clear-cut and consistent across all variables. Comfrey root extract cream showed a remarkably potent and clinically relevant effect in reducing acute back pain. For the first time a fast-acting effect of the ointment (1 hour) was also witnessed in this trial. Conflicts of interest and sources of funding. CS and MT are employees of Merck Selbstmedikation GmbH, the sponsor of the presented clinical trial. BMG is CEO of CRM Pharmaberatung GmbH, the CRO of the presented clinical trial

Total hip arthroplasty (THA) is one of the most successful surgery. However, patients' expectations have increased over the last two decades in regards to hip function after joint replacement, the patients assume to return their daily and sport activities without major limitations. This presentation will examine the effect of surgical approaches and implant designs as well as rehabilitation protocol on the clinical and biomechanical outcomes after THA. The new implant designs for THA aim to improve joint function whereas the surgical approaches intend to reduce muscle damage to regain muscle strength. One important determinant measured from gait analysis is the hip abduction moment as the abductors play a key role in stabilizing the pelvis in the frontal plane, particularly in phases of transition, such as the single leg stance in walking or stair climbing. This showed that muscle strength needs to be preserved. To minimize the risk of hip joint instability, a strong focus of implant development has been carried out. To illustrate this important concept within the context of gait analysis, I will present two studies that examine the influence of surgical approach and biomechanical reconstruction; and the second, is a prospective RCT comparing a dual mobility implant to a standard total hip replacement