Displaced acetabular fractures in the older patient present significant treatment challenges. There is evidence the morbidity and mortality associated is similar to the fractured neck of femur cohort. Despite growing literature, there remains significant controversy regarding treatment algorithms; varying between conservative management, to fracture fixation and finally surgical fixation and simultaneous THA to allow immediate full weight bearing. £250k NIHR, Research for Patient Benefit (Ref: PB-PG-0815-20054). Trial ethical approval (17/EE/0271). After national consultation, 3 arms included; conservative management, fracture fixation and simultaneous fracture fixation with THA. Statistical analysis required minimum 12 patients/3 arms to show feasibility, with an optimum 20/arm. Inclusion criteria; patients >60 years & displaced acetabular fracture. Exclusion criteria: open fracture, THA in situ, pre-injury immobility, polytrauma. Primary outcome measure - ability recruit & EQ-5D-5L at 6 months. Secondary outcome measures (9 months); OHS, Disability Rating Index, radiographs, perioperative physiological variables including surgery duration, blood loss, complications and health economics. 11 UK level 1 major trauma centres enrolled into the trial, commenced December 2017. Failure surgical equipoise was identified as an issue regarding recruitment. Full trial recruitment (60 patients) achieved; 333 patients screened. 66% male, median age 76 (range 63–93), median BMI 25 (range 18–37), 87% full mental capacity, 77% admitted from own home. 75% fall from standing height. 60% fractures; anterior column posterior hemi-transverse. Trial feasibility confirmed December 2020. Presented data- secondary outcomes that are statistically significant in improvement from baseline for only the fix and replace arm, with acceptable trial complications. Issues are highlighted with conservative management in this patient cohort. Our unique RCT informs design and sample size calculation for a future RCT. It represents the first opportunity to understand the intricacies of these treatment modalities. This RCT provides clinicians with information on how best to provide management for this medically complex patient cohort

Background The three professional groups of chiropractic, osteopathy and musculoskeletal physiotherapy are involved in the management of 15–20% of people with low back pain (LBP) in the UK (CSAG 1994). Exploratory and descriptive research suggests that the management of non-specific low back pain (LBP) by some members of these groups does not follow best available evidence (RCGP 1999). Purpose To test the short-term effectiveness (at 6 months) of a directly-posted, contextualised, printed educational package about the evidence-based management of acute back pain on changing UK chiropractors’, osteopaths’ and musculoskeletal physiotherapists’:. 1) beliefs and attitudes about LBP. 2) reported practice (using a clinical vignette). Methods A prospective, pragmatic randomised trial was designed to test the effectiveness of the printed educational package versus a no-intervention control. MREC approval was gained and a questionnaire was developed and piloted (n=150). Information was gathered on practitioners’ demographics, their beliefs about LBP (using the HC-PAIRS, Rainville et al 1995) and reported practice based on a vignette of a patient with non-specific LBP (adapted from Bombardier et al 1995, Buchbinder 2001). A total of 3602 questionnaires were posted to simple random samples of UK registered chiropractors (n=611), osteopaths (n=1367) and physiotherapists (n=1624). Intervention packages were sent to consenting practitioners in March 2004, and the follow-up is planned for September 2004. Results Good response rates to the baseline questionnaire were obtained, and most respondents were willing to participate in the RCT. Following exclusions based on a priori criteria, 1773/3402 (52.1%) participants were recruited for the RCT: chiropractors 335/604 (55.4%), osteopaths 600/1338 (44.8%) and physiotherapists 838/1460 (57.4%). The RCT methodology and some baseline data will be presented. Conclusions It is possible to recruit large numbers of healthcare practitioners, within and outside the NHS, to RCTs conducted by post. Whilst the results will be specific to these three professional groups in the UK, this study is believed to be the largest RCT of printed, evidence-based educational material in healthcare, to incorporate a no-intervention control group

Introduction. The number of revisions of total knee replacements (TKR) increases annually. Because of reduced bone stock, stable fixation of the implant is important. The femoral and tibial components are usually cemented whereas stems can be placed either cemented or press-fit (hybrid construct). To assess the stability of revision TKR with either cemented or hybrid places implants a randomized controlled trial (RCT) was executed, by using radiostereometric analysis (RSA). The short-term results of this RCT showed no differences between the two groups in stability and clinical outcomes. Although there were no clinical or radiological signs of loosening, both groups showed implants micromotion > 1 mm or degree. These findings might indicate the possibility of loosening later in time; therefore, the current study investigated the stability of cemented versus hybrid-placed revision TKR 6.5 years after surgery. Additionally, clinical results were evaluated. Methods. Of the 32 patients in the original RCT, 23 (12 cement, 11 press-fit) were available for mid-term follow-up measures. RSA images taken at baseline, 6 weeks, 3, 6, 12 and 24 months postoperatively were used from the previous study. New RSA images were taken at median 6.5 years (range 5.4–7.3) postoperatively. Stability of the femoral and tibial implants was assessed by using model-based RSA software (RSAcore, Leiden, The Netherlands) to determine micromotion. Clinical results were evaluated using the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), active flexion, and VAS pain and satisfaction. Stability and clinical outcome were compared between the two groups using independent t-tests or Mann-Whitney U tests when applicable. Results. The median total translation at 6.5 years was 0.37 (0.13–1.96) mm and median total rotation 0.62 (0.11 – 2.81)° for the femoral component. For the tibia component the median total translation was 0.41 (0.10 – 1.04) mm and the median total rotation 0.61 (0.09 – 1.99)°. There were no differences in total translation and total rotation of the femoral and tibial component between the two groups. Additionally, none of the clinical scores differed between the groups. Interestingly, in the group with cemented stems five tibia implants showed > 1 mm or degree migration compared to zero in the hybrid group (p=0.02; Figure 1). Conclusion. There was no difference in stability and clinical outcome between fully cemented and hybrid-placed revision TKR 6.5 years postoperatively. Until now micromotion >1 mm or degree in the tibial components of the cemented group has not yet resulted in re- revisions. The patients will be followed to examine the consequences of these amounts of micromotion in this type of implant in the long-term. Figure 1. Scatter plot of total translation (x-axis) and total rotation (y-axis) for the tibia component at 6.5 years follow-up for fully cemented and hybrid-placed revision TKA

Aims. This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. Methods. This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a ‘good’ recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals. Discussion. A multicentre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery. Cite this article: Bone Jt Open 2021;2(11):909–920

Introduction and Aims A randomised controlled trial (RCT) and a multi-centre unilateral cohort study were performed as part of the stepwise introduction of a new mobile bearing knee. The aim was to ensure that outcome for the new device was at least as good as that for an established fixed bearing device. This paper presents three year follow up of the published one year results. Instability and prevalence of “clicking” from the joint were examined in detail. Method 1. A multi-centre RCT of patients undergoing bilateral knee replacement compared functional outcome between two different prostheses, the new mobile bearing device (TMK) and an established fixed bearing device (AGC). 2. A separate multi-centre cohort of 166 patients who had undergone a unilateral mobile bearing procedure at least six months previously was used to assess complication rate and corroborate any findings from the bilateral trial. Outcome measures included Oxford Knee Scores, American Knee Society ratings and complication rate. Results The bilateral trial revealed no significant differences in outcome between the two devices. Revision rate for all (199) mobile bearing knees was less than 2%. The mean Oxford Knee Score for outcome for all mobile bearing knees was 37.1 ± 10.1. About 7% of patients reported instability. Clicking was more common in the TMK (48%) than in the AGC (30%) and was reported as a problem in 16% of TMK’s in the cohort study. However, clicking was unrelated to outcome score in both studies. Conclusion At three years, the mobile bearing device was as good as the fixed bearing device. There was a relatively high prevalence of “clicking” in the TMK but the cause remains unclear. Furthermore, the symptom was not associated with poor functional outcome. The bilateral RCT and cohort study allows assessment of function and potential problems. It provides rigourous scientific justification for the introduction and early assessment of new implants

This project highlights the red flags in postoperative rehabilitation of total ankle replacement (TAR) patients managed with two different postoperative rehab regimes. 20 TAR patients were recruited for a pilot RCT between 2008 and 2011; they were randomized to 2 groups (immobilisation in a below knee plaster cast for 6 weeks vs. early mobilisation following TAR); all patients underwent a graded outpatient Physiotherapy program until 12 weeks postoperatively. Assessments included questionnaires, complications, American Orthopaedic Foot and Ankle Score (AOFAS) done preoperatively, 3 and 6 months after surgery. Results. 20 TARs for OA (13) and PTOA (7) took part in the trial. There were 10 patients in each arm of the study. Mean age 61.2 years; mean BMI was 29.4. Of the plaster group, there was 1 incidence of fracture medial malleolus (MM) at 6 weeks after removal of plaster cast, 1 fracture MM at 5 months following walking on the beach, 1 fracture (MM) after completion of outpatient physiotherapy session, and 1 fracture MM of unknown reason at 1 year. Of the early mobilisation group, there was 1 intraoperative fracture of tibia (treated conservatively); 1 fracture MM 6 weeks post-op; 2 fracture MM at 8 weeks post-op. All patients had good clinical outcomes at successive follow up assessments. Conclusion. These results highlights the need for considering a lighter exercise regime, and re-evaluating patient lifestyle, return to recreational activities and feedback on home exercise programs during planning and execution of each phase of postoperative rehabilitation programs to aid prevention of early fractures in patients following TAR

Joint registries suggest a downward trend in the use of uncemented Total Knee Replacements (TKR) since 2003, largely related to reports of early failures of uncemented tibial and patella components. Advancements in uncemented design such as trabecular metal may improve outcomes, but there is a scarcity of high-quality data from randomised trials.

319 patients <75 years of age were randomised to either cemented or uncemented TKR implanted using computer navigation. Patellae were resurfaced in all patients. Patient outcome scores, re-operations and radiographic analysis of radiolucent lines were compared.

Two year follow up was available for 287 patients (144 cemented vs 143 uncemented). There was no difference in operative time between groups, 73.7 v 71.1 mins (p= 0.08). There were no statistical differences in outcome scores at 2 years, Oxford knee score 42.5 vs 41.8 (p=0.35), International Knee Society 84.6 vs 84.0 (p=0.76), Forgotten Joint Score 66.7 vs 66.4 (p=0.91). There were two revisions, both for infection one in each group (0.33%). 13 cemented and 8 uncemented knees underwent re-operation, the majority of these being manipulation under anaesthetic (85.7%), with no difference (8.3% vs 5.3%, 95% CI -2.81% to 8.89%, p = 0.31). No difference was found in radiographic analysis at 2 years, 1 lucent line was seen in the cemented group and 3 in the uncemented group (0.67% v 2.09%, 95%CI -4.1% to 1.24%, p = 0.29).

We found no difference in clinical or radiographic outcomes between cemented and uncemented TKR including routine patella resurfacing at two years.

Early results suggest there is no difference between cemented and uncemented TKR at 2 years with reference to survivorship, patient outcomes and radiological parameters.

We have performed an RCT of cross-linked versus non cross-linked polyethylene with 125 patients followed for five years. The study showed a dramatic reduction of wear with the cross-linked polyethylene consistent with the in-vitro studies. Because it has been recognised that hard bearings are sensitive to edge loading we were concerned that highly cross-linked polyethylene might exhibit wear properties similar to hard bearings. We have therefore analysed the wear rate as it relates to both anteversion and tilt, to compare non cross-linked polyethylene with cross-linked polyethylene. We found that there was no relationship between tilt and ante-version on any wear indices. These data suggest that, despite having different mechanical properties to non cross-linked polyethylene, cross-linked polyethylene does not exhibit increased wear with conditions that increase edge loading

Aim. The purpose of this study was to perform a randomised controlled trial (RCT) to compare the >20 year outcomes of cemented versus cementless Mallory Head total hip replacements (THRs). Methods. Two hundred and fifty patients with unilateral osteoarthritis of their hip, a mean age of 64 years and 48% of whom were female were randomised to receive either a cemented (n=124) or cementless (n=126) THR. Results. At >20 years follow-up, the cementless Mallory Head THR outperformed its cemented counterpart in terms of overall Kaplan Meier survivorship (p=0.01), socket survivorship (p=0.009) and stem survivorship (p< 0.0001). Age significantly affected acetabular socket revision rates for both cementless (>65 - 12% versus < 65 - 36%, p=0.003) and cemented (>65 - 19% versus < 65 - 55%, p< 0.0001) sockets. Male gender adversely affected cementless (males - 31% versus females - 12%, p=0.01), but not cemented (males - 35% versus females - 36%, p=1.000) socket survivorships. For the femoral stems, age did not affect cementless stem survivorship (>65 - 0% versus < 65 - 2%, p=0.465), but did so with cemented stems (>65 - 16% versus < 65 - 33%, p=0.001). Gender did not influence cementless or cemented stem survivorships. Conclusion. This RCT has demonstrated that cementless THRs offer significantly better overall, socket and stem survivorships at 20 or more years. The cementless tapered femoral stem performed particularly well with 100% survivorship at 20 years, excluding infections. Caution should be taken in generalising these results to other cemented and cementless THRs

Purpose: The purpose of this prospective blinded randomized control trial was to compare the stem migration of two cemented stem designs using radiostereometric analysis (RSA). This was essentially a safety study in which our hypothesis was that the newer design (CPCS, Smith and Nephew Inc) would demonstrate similar micro-motion to the well-established Exeter (Stryker) design. Method: Thirty patients were consented and enrolled into a blinded RCT in which 15 patients received a dedicated RSA CPCS stem and 15 patients received a RSA Exeter stem. Both stems are collarless tapered polished cemented stems, the only difference being a slight lateral to medial taper with the CPCS design. Outcome measures were compared (Hip Society Score, WOMAC, SF-12). RSA analysis was conducted immediately postoperatively, at 6 weeks, 3 months, 6 months, 1 year and 2 years. Results: No difference was found in any of the outcome measures pre-operatively or postoperatively. At 2 years, stem subsidence for the CPCS stem was approximately half that seen for the Exeter stem (0.565±0.189mm and 0.981±0.209mm respectively, p< 0.0001). In contrast, posterior (internal) rotation of the CPCS was approximately twice that of the Exeter stem (1.496±1.215° and 0.716±0.818° respectively, p=0.221). Other migration patterns were no different between stems. Conclusion: As expected with this stem design, both stems showed some axial and rotational migration within the cement mantle. The subtle differences in design may explain the differences in migration patterns. Our data suggests that the newer CPCS design should perform well over the long-term

Aims. Distal third clavicle (DTC) fractures are increasing in incidence. Due to their instability and nonunion risk, they prove difficult to treat. Several different operative options for DTC fixation are reported but current evidence suggests variability in operative fixation. Given the lack of consensus, our objective was to determine the current epidemiological trends in DTC as well as their management within the UK. Methods. A multicentre retrospective cohort collaborative study was conducted. All patients over the age of 18 with an isolated DTC fracture in 2019 were included. Demographic variables were recorded: age; sex; side of injury; mechanism of injury; modified Neer classification grading; operative technique; fracture union; complications; and subsequent procedures. Baseline characteristics were described for demographic variables. Categorical variables were expressed as frequencies and percentages. Results. A total of 859 patients from 18 different NHS trusts (15 trauma units and three major trauma centres) were included. The mean age was 57 years (18 to 99). Overall, 56% of patients (n = 481) were male. The most common mechanisms of injury were simple fall (57%; n = 487) and high-energy fall (29%; n = 248); 87% (n = 748) were treated conservatively and 54% (n = 463) were Neer type I fractures. Overall, 32% of fractures (n = 275) were type II (22% type IIa (n = 192); 10% type IIb (n = 83)). With regards to operative management, 89% of patients (n = 748) who underwent an operation were under the age of 60. The main fixation methods were: hook plate (n = 47); locking plate (n = 34); tightrope (n = 5); and locking plate and tight rope (n = 7). Conclusion. Our study is the largest epidemiological review of DTC fractures in the UK. It is also the first to review the practice of DTC fixation. Most fractures are being treated nonoperatively. However, younger patients, suffering a higher-energy mechanism of injury, are more likely to undergo surgery. Hook plates are the predominantly used fixation method followed by locking plate. The literature is sparse on the best method of fixation for optimal outcomes for these patients. To answer this, a pragmatic RCT to determine optimal fixation method is required. Cite this article: Bone Jt Open 2022;3(12):953–959

Purpose: A ceramic head coupled to a metal liner is a proposed new alternate bearing in THA. The authors participated in an FDA approved multicentre prospective, randomized, blinded clinical trial comparing ceramic-on-metal (CoM) to metal-on-metal (MoM) in patients receiving a THA. Method: 390 patients received the same acetabular component and metal insert. 194 patients received a delta ceramic head (CoM) and 196 received a metal head (MoM). Metal ions were evaluated in 72 patients (36-CoM, 36-MoM). Harris Hip scores, radiographs, and metal ion levels (cobalt, chromium and titanium in serum, erythrocytes and urine) were evaluated pre-operatively and at three, 12 and 24 months. Results: No patients were lost to follow-up. There were no differences between groups’ baseline demographics and clinical scores. At two years there were no differences in Harris Hip scores, radiographs, adverse events or postoperative complications. Both groups had overall very low median metal ion profiles with no statistically significant differences. 24 month MoM vs CoM; Serum cobalt ( g/L), mean: 1.2(+/−0.5) vs 1.1(+/−0.3), median: 0.66(range: 0.2–5.6) vs 1.0 (range: 0.3–2.7); Serum chromium ( g/L), mean: 1.1(+/−0.5) vs 1.4(+/−0.4), median: 0.86(range: 0.3–6.9) vs 1.2(range: 0.3–4.9). Urine cobalt and urine chromium ( g/day) demonstrated similar trends to serum ion levels. Conclusion: While CoM is a new bearing surface in North America and not currently FDA or HPB approved, it has been in clinical use globally since 2006. Results of this non-inferiority RCT demonstrated no clinical outcome, metal ion, radiographic or adverse event differences between CoM and MoM cohorts

Purpose: Porous metal technology may have significant impacts on implant fixation and long-term survival due to their high co-efficient of friction and similarity to trabecular bone in morphology and mechanical behaviour. While promising, the in vivo mechanical behaviour and micromotion at the interface has not previously been reported on. We report on the 2-year results of an RCT using radiosterometric analysis (RSA) to asses a porous metal (PM) monoblock tibial component. Method: Patients undergoing TKA were randomized to receive a either the PM (n=34) or the cemented tibial component (n=33). A standardized protocol was used for intra and post-operative factors. RSA exams were obtained postoperatively within 4 days of surgery and at 6, 12 and 24 months. One patient was excluded due to an intraoperative complication, and four others were lost to follow-up due to poor bead visibility or morbidity. Standard subjective outcome measures were applied. Results: There were no revisions in either group. The PM group exhibited two distinct migration patterns. One group stabilized immediately with similar migration to the cemented cases (0.38 vs. 0.46 p=0.4). A subset of 6 PM cases demonstrated significantly higher initial migration (mean=2.01mm, p< 0.01) but appeared stable at 2 years. In addition, 3 of the 6 high migration cases manifested independent bead subsidence. This was determined to be due to PM plate deformation. Two cemented cases were considered at risk for early failure due to aseptic loosening because of RSA migration pattern. There were no differences between groups in the subjective health outcome measures. Conclusion: A subset of PM components demonstrated high early migration followed by stabilization. It appears that some of these PM components deformed under load, most often in the posteromedial corner, perhaps as a result of malalignment or ligament imbalance. The implications of this finding are yet to be determined

Introduction. Metal on metal articulations produce chromium (Cr) and cobalt (Co) debris, particularly when the articulations are worn in. High levels in the peripheral blood are indicative of excess wear and may cause adverse effects. The present RCT investigates metal ion levels and the relationship of Co, Cr ions and lymphocyte counts during the running-in period. Materials and Methods. Following randomization to RHA (ASRTM, DePuy) or THA we obtained whole blood (wb), and serum (s) samples at baseline, 8 w, 6 m and 1 y. We measured the Co and Cr concentrations, the total lymphocyte count as well as the CD3+, CD4+, CD8+, CD19+ and CD16+/CD56+ sub populations. Cup inclination and anteversion angles came from conventional radiographs. Activity was measured as steps by pedometer and UCLA activity. Data are presented as median (range). Results. We had 19 patients in each group. Age 57 (46–64) y (RHA) and 55 (44–64) y (THA). RHA only: head size: 51 (47 to 57)mm, cup inclination: 45.0 (40- 56)° and anteversion: 23 (7–38)°. The ion concentrations stayed below 0.2 ppb for THAs. For RHAs the Co and Cr concentrations generally rose markedly in the initial 8 weeks, followed by a slower ascent up to 1 year to wb Co: 1.0 (0.6–5.2), s Co: 1.3 (0.7–6.5), wb Cr: 1.3 (0.4–8.0) and s Cr: 1.7 (0.6–15) ppb. A high ion level was correlated to a small head size (p<0.03) and a cup inclination around 45° (p<0.04). We could not correlate the ion concentrations to the anteversion or the activity levels. The absolute lymphocyte counts were not always identical in the groups (eg. lower CD8+ for RHA) but there was no group difference when we analysed the change from baseline. We did not demonstrate any correlation between metal ion levels and lymphocyte subpopulations. Discussion. The findings of this study does not support the theory that metal ions suppress the lymphocytes or the CD8+ in particular (Hart et al., 2009). Our conclusions are limited by low numbers, but we suspect the theory could be biased by missing baseline values. Our study did not demonstrate the same 6–9 months ion peak found in other running-in studies (Back et al., 2005, Heisel et al., 2008), but rather a slow continuous rise with lower median ion concentrations. It could indicate lower wear or perhaps a longer running in period in our slightly older population. Contrary to our expectations we found that cups placed in optimal inclination displayed a higher ion level. Most of the smallest cups were found in this group, and the majority of the steep cups had very large heads. For this implant head size may be more important than cup position

Aims. It has been suggested that mobile-bearing total knee arthroplasty (TKA) might lead to better outcomes by accommodating some femorotibial rotational mismatch, thereby reducing contact stresses and polyethylene wear. The aim of this study was to determine whether there is a difference between fixed- and mobile-bearing versions of a contemporary TKA with respect to durability, range of movement (ROM) and function, ten years postoperatively. Patients and Methods. A total of 240 patients who were enrolled in this randomized controlled trial (RCT) underwent a primary cemented TKA with one of three tibial components (all-polyethylene fixed-bearing, modular metal-backed fixed-bearing and mobile-bearing). Patients were reviewed at a median follow-up of ten years (IQR 9.2 to 10.4). Results. There was no difference in durability, as measured by survivorship free of revision for any reason, nor in mean maximal ROM at ten years (p = 0.8). There was also no difference in function, as measured by Knee Society (KS) function scores (p = 0.63) or the prevalence of patellar tilt (p = 0.12). Conclusion. In this clinical RCT, the mobile-bearing design of TKA was found to be reliable and durable, but did not provide better maximum knee flexion, function or durability ten years postoperatively compared with a posterior-stabilized, fixed-bearing design incorporating either an all-polyethylene or a modular-metal-backed tibial component. Cite this article: Bone Joint J 2018;100-B:925–9

Background. Balloon kyphoplasty (BKP) is a minimally invasive cementing procedure, occasionally used in patients with painful vertebral compression fractures (VCF). In this multicenter Swedish RCT, we evaluated the cost-effectiveness of BKP compared with standard medical treatment, Control, in osteoporotic patients with acute/sub-acute VCF (<3 months). In a multicenter European clinical study (FREE trial) including 300 patients and FU after one year, BKP was suggested to be a safe and effective procedure in selected patients. The current study includes the Swedish patients in the FREE trial Method: Hospitalized patients with a back pain level of at least 4/10 on a visual analogue scale due to of VCF between Th5–L5 (confirmed by MRI) were randomized to either BKP or Control treatment (standard medical treatment with pain medication and functional support). All VCF-associated costs (hospital, primary care, rehabilitation, community care, private care, pharmaceuticals, assistance by relatives, work absenteeism) were identified and reported from the perspectives of cost to society, and costs to the healthcare system. Primary outcome was quality of life change (QoL) measured with the preference based EQ-5D instrument. The accumulated quality adjusted life years gained (QALYs) and costs per QALY gained was assessed. Willingness to pay (WTP) for a QALY gained in Sweden was estimated at approximately SEK 600,000 (EURO 62,500). Sensitivity analyses were performed. Results. Between February 2003 and December 2005, 70 patients were randomized to BKP (n=35) or to standard medical treatment (n=35). Three patients in the Control group declined to participate in an economic evaluation, and only patients answering EQ-5D at all FU occasions (1-3-6-12-24 months) were included in the analyses, leaving in all 63 patients, BKP=32, Control=31. Baseline data were similar. The mean age in the BKP group was 72 years (71% women) vs. 75 years (78% women) in the Control group. Baseline difference in QoL was adjusted for using statistical methods. There were no cross overs. Four patients in the BKP group and three patients in the Control group died within two years of causes not related to the VCF. Costs were collected using “cost diaries” in mailed questionnaires after 1-3-6-12-18-24 months. Costs and EQ-5D values (0 at FU after death) were carried forward. Total mean societal cost per patient for BKP and Control was SEK 160,017 (SD 151,083) and SEK 84,816 (SD 40,954), respectively. The difference was significant 75,198 (95% CI 16,037 to 120,104). The accumulated mean difference in QALYs was 0.085 (−0.132 to 0.306) units in favour of BKP. Cost per QALY gained using BKP was SEK 884,682 (EURO 92,154) with high uncertainty assessed using the bootstrapping technique, and demonstrated on the cost-effectiveness plane and on the acceptability curve. When the EQ-5D values from all patients in the FREE trials were included in a sensitivity analysis, cost/QALY was SEK 359,146 (EURO 37,411) Conclusion: Costs were significantly higher for BKP compared with standard medical treatment, with no significant difference in QALYs gained. In this selected patient population with vertebral compression fracture due to osteoporosis, BKP could not be concluded as cost-effective after two years

Aim

This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial.

The use of wound drains in arthroplasty patients is controversial. Previous work including a meta analysis looking at closed drainage systems has shown no benefit in their use. It is postulated that retransfusion drains may offer an advantage over closed drains and cut allogenic transfusion requirements and aid wound healing. This study was designed to assess the use of retransfusion drains in hip and knee replacement patients and prove the null hypothesis that there is no difference in post op haemaglobin levels or transfusion with their use.

Following an initial pilot audit of blood drainage in such patients we designed a protocol for a prospective trial. In a prospective randomised controlled study we evaluated the use of retransfusion drains in primary hip and knee arthroplasty patients. Eighty patients were randomised to removal of the drain at six or twenty-four hours post op, to assess the most efficient and beneficial use of such drains. The rate of blood drainage, post-operative haemaglobin (Hb) levels, blood transfusion, hospital stay, complications and rehabilitation observed. The two groups were comparable, have a follow up of two years and all attempts to control variables were made.

The drop in haemaglobin, hospital stay, complications and rehabilitation between both groups revealed no significant difference in all respects. Wound healing appeared better in six-hour group for hip and knee patients. There is no effect of type of joint or age on the drop in Hb. The TKR patients drained sig. more blood than the THR patients. The rate of blood loss is discussed. The amount of blood drained that was retransfused was 94% efficient. The allogenic transfusion rates were higher in the six-hour knee group. Three patients required post operative antibiotic but at latest follow up all patients were reported as having no problems and no evidence of infection.

This study concludes that retransfusion drains offer no advantage in the arthroplasty patients’ care.

The aim of this study was to test the efficacy of shock-wave therapy for chronic Achilles pain. Forty-nine patients with Achilles tendon pain for a minimum of 4 months were included in the study. Patients were randomised to either shockwave therapy (n=27) or placebo control (n=22). The treatment group were given 2000 shocks at up to 1500 mJ/mm2 per shock. The control (sham) treatment was applied using the same parametres but the shockwaves were dispersed before they reached the patient. Each patient was treated once a month over 3 months. The primary outcome measure was pain on walking indicated on a 100mm visual analogue score (VAS) at 3 months. The walking pain scores were very similar at baseline between the two groups. In the treatment group the mean (standard deviation) was 55.5 mm (30.6) and in the control group 55.6mm (26.5). By 3 months, the pain scores had reduced in both groups to a mean (standard deviation) of 34.5 mm (34.2) and 50.3 mm (36.3). Although lower in the treatment group this difference was not statistically significant at the 5% level (t-test, p=0.127, 95% CI : −4.7 to 36.2). Two elderly patients in the treatment group sustained spontaneous rupture of the tendon after falls during the course of the trial. The results of this trial provided no evidence for the use of shockwave therapy in the treatment of patients with chronic Achilles tendinopathy. However, a treatment effect cannot be ruled out since the 95% confidence interval included a potential clinically relevant difference. The two cases of rupture suggest extreme caution in treating the elderly.