To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds.Purpose and background
Methods and results
This multi-centre randomised controlled trial evaluated the clinical and cost effectiveness of liposomal bupivacaine for pain and recovery following knee replacement. 533patients undergoing primary knee replacement were randomised to receive either liposomal bupivacaine (266mg) plus bupivacaine hydrochloride (100mg) or control (bupivacaine hydrochloride 100mg), administered at the surgical site. The co-primary outcomes were pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours and the Quality of Recovery 40 (QoR-40) score at 72hours.Abstract
Introduction
Methodology
There is a lack of evidence as to the best way to deliver rehabilitation following TKA. Previous work has suggested that postoperative physiotherapy applied to all patients is not effective at improving one-year post-surgical outcomes. The aim of this study was to target physiotherapy to those at risk of poor outcome following TKA, and to determine if a therapist-led intervention offered superior results compared to a home-exercise based protocol in this ‘at risk’ group. The Targeted Rehabilitation to Improve Outcomes (TRIO) study was a prospective randomised controlled trial run at 15-centres in the UK. Patients were identified as ‘potential poor outcome’ based on an Oxford Knee Score (OKS) classification at 6-weeks post-surgery and randomised to either therapist-led or home-exercise based protocols. Patients were reviewed by a physiotherapist and commenced 18-exercise sessions over 6-weeks. The therapist-led group undertook a progressive functional protocol (modified weekly in 1-1 contact sessions) in contrast to the static home-exercise based regime. Evaluation took place following rehabilitation intervention, then at 6-months and 1-year post-surgery. Primary outcome was comparative group OKS at 1-year. Secondary outcomes included, ‘worst’ and ‘average’ pain scores, OXS and EQ-5D, and satisfaction questionnaire. Health economic (cost-utility) analysis was undertaken from NHS perspective up to 1-year post-surgery. Incremental cost per Quality Adjusted Life Years (QALYs) were calculated from intervention costs, patient reported primary and secondary care usage, and EQ-5D data. 4264 patients were screened, 1296 were eligible, 334 patients were randomised, 8 were lost to follow-up, therapy compliance was >85%. Clinically meaningful improvement in OKS (between baseline and 1-year) was seen in both arms (p < 0 .001). Between group difference in 1-year OKS was 1.91 (95%CI, −0.17–3.99) points favouring the therapist-led arm (p=0.07). Incorporating all time point data, between group difference in OKS was 2.25 points (95%CI, 0.61–3.90, p=0.008). Small, non-significant reductions (< 5 %) in both worst and average pain scores were observed favouring the therapist-led group. Enhanced satisfaction with pain relief (OR 1.65, p < 0 .02), ability to perform daily functional tasks (OR 1.66, p < 0 .02), and perform heavy functional tasks (OR 1.6, p=0.04) was reported in the therapist-led group. There was a small non-significant difference of 0.02 points (95%CI −0.02–0.06) between groups in EQ-5D, resulting in a £12,125 cost per QALY of delivering the therapist led intervention with a 57% chance of being cost-effective at the standard UK policy threshold of £20,000 per QALY. TRIO is the largest randomised trial of physiotherapy following TKA, and the first to target rehabilitation to patients at risk of poor outcomes. Both therapist-led and home-exercise based rehabilitation groups made clinically meaningful improvements in outcome by 1-year. We observed a modest difference in OKS in favour of therapist-led rehabilitation compared to the home-exercises which was not statistically significant. The relatively tight confidence intervals suggests that any difference which might exist is too small to be clinically relevant. Patient satisfaction with outcome was however higher in those that received greater physiotherapist contact. While cost per QALY estimates were below UK policy threshold, this result is uncertain and insufficient to make accept-decline recommendations.
Despite interest, the current rate of day-case anterior cruciate ligament reconstruction (ACLR) in the UK remains low. Although specialised care pathways with standard operating procedures (SOPs) have been effective in reducing length of stay following some surgical procedures, this has not been previously reported for ACLR. We evaluate the effectiveness of SOPs for establishing day-case ACLR in a specialist unit. Fifty patients undergoing ACLR between May and September 2010 were studied prospectively (“study group”). SOPs were designed for pre-operative assessment, anaesthesia, surgical procedure, mobilisation and discharge. We evaluated length of stay, readmission rates, patient satisfaction and compliance to SOPs. A retrospective analysis of 50 patients who underwent ACLR prior to implementation of the day-case pathway was performed (“standard practice group”).Background
Methods
The purpose of this study was to determine if a single physiotherapy intervention would enable patients to kneel following Unicompartmental knee arthroplasty (UKA). Kneeling is an important functional activity that is frequently not performed after knee arthroplasty, thus affecting a patient’s ability to carry out basic tasks of everyday life. There is however no clinical reason why patients should not kneel and many with proposed knee surgery ask about the possibility of kneeling after their operation. Sixty adults participated in a prospective randomised controlled trial with blinded assessments. At 6 weeks post-operatively UKA patients were randomised to either the Routine care group where no advice on kneeling was given or to the Kneeling intervention group where participants were taught and given advice on how to kneel and were encouraged to do so. They were re-assessed at 1 year. The primary outcome measure was Question 7 of the Oxford Knee Score which asks the question “Could you kneel down and get up again afterwards?” Pre-operatively there was no difference in the kneeling ability of the two groups. At 1 year the difference in kneeling ability between the two groups was highly significant (p<
0.05). Spearman’s correlation coefficient showed no significant association between a change in score of Question 7 at 1 year and the following factors; scar position, numbness, range of flexion, arthritic involvement of other joints and pain. Linear regression analysis also confirmed that these factors were not successful in predicting a change in kneeling ability. This study showed that the single factor predictive of kneeling ability was the physiotherapy intervention provided at 6 weeks post-operatively and it is suggested that kneeling should be incorporated into patient’s post-operative rehabilitation programmes.
To investigate if pre-operative measures of function were predictive of length of stay for patients treated in a Diagnostic &
Treatment Centre for elective hip arthroplasty. The first 75 patients treated by the DTC were assessed pre-operatively recording timed measures of function for sit-to-stand, and stair climbing as well as ratings of pain and the WOMAC questionnaire. These measures were compared with the LOS for patients and their functional outcome at 6 weeks after discharge. Linear regression was used to examine the influence of the measures on LOS. T-tests were used to compare the outcome at 6 weeks for pain and function between patients discharged within 5 days versus >
5 days. The mean age was 65 years (39 – 80 years SD 8.4); 33 male and 42 female. Mean LOS was 6 days (4–14 SD 1.8), 52 % reached the DTC target of discharge on the 5th day. Regression analysis showed sit-to- stand was the best predictor of LOS (R2 = 46.7%) followed by WOMAC pain and climbing stairs. There were no significant differences in the pain or function scores at 6 weeks for patients discharged at 5 days or later.
Proprioception protects joints against injurious movements and is critical for joint stability maintenance under dynamic conditions. Knee replacement effect on proprioception in general remains elusive. This study aimed to evaluate the changes in proprioceptive performance after knee replacement; comparing Total (TKA) to Unicompartmental Knee Arthroplasty (UKA). Thirty-four patients with osteoarthritis were recruited; 15 patients underwent TKA using the AGC prosthesis and 19patients underwent UKA using the Oxford prosthesis. Both cruciate ligaments were preserved in the UKA group, while only the PCL was preserved in TKA patients. Patients’ age was similar in both groups.>
Joint Position Sense (JPS) and postural sway were used as measures of proprioception. Both groups were assessed pre- and 6 months post-operatively in both limbs. JPS was measured as the error in actively and passively reproducing five randomly ordered knee flexion angles between 30 and 70°using an isokinetic dynamometer. Postural sway (area and path) was measured during single leg stance using a Balance Performance Monitor. Functional outcome was assessed using the Oxford Knee Score (OKS). Pre-operatively, no differences in JPS or sway were found between limbs in either group. No differences existed between the two groups. Post-operatively, both groups had significant improvement of JPS in the operated limb (UKA mean4.64°, SD1.44° and TKA mean5.18°, SD1.35°). No changes in JPS were seen in the control side. A significant improvement (P<
0.0001) in sway area and path was found in the UKA group only in both limbs. No significant changes in sway occurred in either limb of TKA patients. The OKS improved from 21.4 to 35.5 for TKA patients and from 23.9 to 38for UKA patients. Both UKA and TKA improve proprioception as assessed by JPS. However, UKA alone improves postural sway in both limbs. This may impart explain why UKA patients function better than TKA patients
The surgery results parallel those reported in other trials. At two years, the treatment costs of the surgery arm were approximately twice those of the rehabilitation arm. The costs of the rehabilitation strategy depend on how many patients opt to have surgery after rehabilitation (22% in this trial). This is a comparison of treatment strategies: there was no clinical or statistical difference in outcome between the strategy of spinal fusion and rehabilitation.
Joint Position Sense (JPS) &
sway were used as measures of proprioception performance. Both groups were assessed pre- and 6 months post-op. JPS was measured using an isokinetic dynamometer (KinCom, Chatanooga Ltd) as the error in actively and passively reproducing fi ve randomly ordered knee fl exion angles (30°, 40°, 50°, 60° and 70°). Sway (area, path and velocity) was measured during single leg stance using a Balance Performance Monitor (SMS Medical) for 30-second interval. Functional outcome was assessed using the Oxford Knee Score (OKS). Pre-operatively, no differences in JPS or sway were found between limbs in either group. No differences existed between the two groups. Post-operatively, both groups had signifi cant improvement of JPS in the operated limb only (Mean ± standard deviation for UKA 4.64±1.44° and for TKA 5.18±1.35°). No changes in JPS were seen in the control side. Group 2 patients showed signifi cant improvement in both sway area and path (p<
.0001) for both limbs post-operatively. No signifi cant post-operative changes in sway occurred in either limb of Group 1 patients. The OKS improved post-operatively in both groups, rising from 21.4 to 35.5 for Group 1 patients and from 23.9 to 38 for Group 2 patients.