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The Bone & Joint Journal
Vol. 101-B, Issue 1 | Pages 55 - 62
1 Jan 2019
Rombach I Merritt N Shirkey BA Rees JL Cook JA Cooper C Carr AJ Beard DJ Gray AM

Aims

The aims of this study were to compare the use of resources, costs, and quality of life outcomes associated with subacromial decompression, arthroscopy only (placebo surgery), and no treatment for subacromial pain in the United Kingdom National Health Service (NHS), and to estimate their cost-effectiveness.

Patients and Methods

The use of resources, costs, and quality-adjusted life-years (QALYs) were assessed in the trial at six months and one year. Results were extrapolated to two years after randomization. Differences between treatment arms, based on the intention-to-treat principle, were adjusted for covariates and missing data were handled using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty around the values estimated using bootstrapping.


Bone & Joint Open
Vol. 5, Issue 6 | Pages 464 - 478
3 Jun 2024
Boon A Barnett E Culliford L Evans R Frost J Hansen-Kaku Z Hollingworth W Johnson E Judge A Marques EMR Metcalfe A Navvuga P Petrie MJ Pike K Wylde V Whitehouse MR Blom AW Matharu GS

Aims. During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. Methods. The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group. Conclusion. The trial findings will provide evidence about the clinical and cost-effectiveness of always patellar resurfacing compared to selective patellar resurfacing. This will inform future NICE guidelines on primary TKR and the role of selective patellar resurfacing. Cite this article: Bone Jt Open 2024;5(6):464–478


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 961 - 970
1 Sep 2023
Clement ND Galloway S Baron YJ Smith K Weir DJ Deehan DJ

Aims. The primary aim was to assess whether robotic total knee arthroplasty (rTKA) had a greater early knee-specific outcome when compared to manual TKA (mTKA). Secondary aims were to assess whether rTKA was associated with improved expectation fulfilment, health-related quality of life (HRQoL), and patient satisfaction when compared to mTKA. Methods. A randomized controlled trial was undertaken, and patients were randomized to either mTKA or rTKA. The primary objective was functional improvement at six months. Overall, 100 patients were randomized, 50 to each group, of whom 46 rTKA and 41 mTKA patients were available for review at six months following surgery. There were no differences between the two groups. Results. There was no difference between rTKA and mTKA groups at six months according to the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) functional score (mean difference (MD) 3.8 (95% confidence interval (CI) -5.6 to 13.1); p = 0.425). There was a greater improvement in the WOMAC pain score at two months (MD 9.5 (95% CI 0.6 to 18.3); p = 0.037) in the rTKA group, although by six months no significant difference was observed (MD 6.7 (95% CI -3.6 to 17.1); p = 0.198). The rTKA group were more likely to achieve a minimal important change in their WOMAC pain score when compared to the mTKA group at two months (n = 36 (78.3%) vs n = 24 (58.5%); p = 0.047) and at six months (n = 40 (87.0%) vs n = 29 (68.3%); p = 0.036). There was no difference in satisfaction between the rTKA group (97.8%; n = 45/46) and the mTKA group (87.8%; n = 36/41) at six months (p = 0.096). There were no differences in EuroQol five-dimension questionnaire (EQ-5D) utility gain (p ≥ 0.389) or fulfilment of patient expectation (p ≥ 0.054) between the groups. Conclusion. There were no statistically significant or clinically meaningful differences in the change in WOMAC function between mTKA and rTKA at six months. rTKA was associated with a higher likelihood of achieving a clinically important change in knee pain at two and six months, but no differences in knee-specific function, patient satisfaction, health-related quality of life, or expectation fulfilment were observed. Cite this article: Bone Joint J 2023;105-B(9):961–970


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 663 - 671
1 Jun 2022
Lewis E Merghani K Robertson I Mulford J Prentice B Mathew R Van Winden P Ogden K

Aims. Platelet-rich plasma (PRP) intra-articular injections may provide a simple and minimally invasive treatment for early-stage knee osteoarthritis (OA). This has led to an increase in its adoption as a treatment for knee OA, although there is uncertainty about its efficacy and benefit. We hypothesized that patients with early-stage symptomatic knee OA who receive multiple PRP injections will have better clinical outcomes than those receiving single PRP or placebo injections. Methods. A double-blinded, randomized placebo-controlled trial was performed with three groups receiving either placebo injections (Normal Saline), one PRP injection followed by two placebo injections, or three PRP injections. Each injection was given one week apart. Outcomes were prospectively collected prior to intervention and then at six weeks, three months, six months, and 12 months post-intervention. Primary outcome measures were Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQol five-dimension five-level index (EQ-5D-5L). Secondary outcomes included visual analogue scale for pain and patient subjective assessment of the injections. Results. A total of 102 patients were recruited. The follow-up period was 12 months, at intervals of six weeks, 12 weeks, six months, and 12 months. KOOS-Total significantly improved in all groups at these time intervals compared to pre-injection. There was an improvement in EQ-5D-5L index scores in saline and single injection groups, but not in the multiple injection group. Comparison of treatment groups showed no additional beneficial effect of single or multiple PRP injections above that displayed in the saline injection group. Subjective patient satisfaction and recommendation of treatment received demonstrated a similar pattern in all the groups. There was no indication of superiority of either single or multiple PRP injections compared to saline injections. Conclusion. There is no evidence that single or multiple PRP had any additional beneficial effect compared to saline injection up to 12 months, follow-up after treatment of early stage symptomatic OA of the knee. Cite this article: Bone Joint J 2022;104-B(6):663–671


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 728 - 734
1 Jul 2024
Poppelaars MA van der Water L Koenraadt-van Oost I Boele van Hensbroek P van Bergen CJA

Aims. Paediatric fractures are highly prevalent and are most often treated with plaster. The application and removal of plaster is often an anxiety-inducing experience for children. Decreasing the anxiety level may improve the patients’ satisfaction and the quality of healthcare. Virtual reality (VR) has proven to effectively distract children and reduce their anxiety in other clinical settings, and it seems to have a similar effect during plaster treatment. This study aims to further investigate the effect of VR on the anxiety level of children with fractures who undergo plaster removal or replacement in the plaster room. Methods. A randomized controlled trial was conducted. A total of 255 patients were included, aged five to 17 years, who needed plaster treatment for a fracture of the upper or lower limb. Randomization was stratified for age (five to 11 and 12 to 17 years). The intervention group was distracted with VR goggles and headphones during the plaster treatment, whereas the control group received standard care. As the primary outcome, the post-procedural level of anxiety was measured with the Child Fear Scale (CFS). Secondary outcomes included the children’s anxiety reduction (difference between CFS after and CFS before plaster procedure), numerical rating scale (NRS) pain, NRS satisfaction of the children and accompanying parents/guardians, and the children’s heart rates during the procedure. An independent-samples t-test and Mann-Whitney U test (depending on the data distribution) were used to analyze the data. Results. The post-procedural CFS was significantly lower (p < 0.001) in the intervention group (proportion of children with no anxiety = 78.6%) than in the control group (56.8%). The anxiety reduction, NRS pain and satisfaction scores, and heart rates showed no significant differences between the control group and the intervention group. Subanalyses showed an increased effect of VR on anxiety levels in young patients, females, upper limb fractures, and those who had had previous plaster treatment. Conclusion. VR effectively reduces the anxiety levels of children in the plaster room, especially in young girls. No statistically significant effects were seen regarding pain, heart rate, or satisfaction scores. Cite this article: Bone Joint J 2024;106-B(7):728–734


Bone & Joint Research
Vol. 10, Issue 12 | Pages 807 - 819
1 Dec 2021
Wong RMY Wong PY Liu C Chung YL Wong KC Tso CY Chow SK Cheung W Yung PS Chui CS Law SW

Aims. The use of 3D printing has become increasingly popular and has been widely used in orthopaedic surgery. There has been a trend towards an increasing number of publications in this field, but existing literature incorporates limited high-quality studies, and there is a lack of reports on outcomes. The aim of this study was to perform a scoping review with Level I evidence on the application and effectiveness of 3D printing. Methods. A literature search was performed in PubMed, Embase, and Web of Science databases. The keywords used for the search criteria were ((3d print*) OR (rapid prototyp*) OR (additive manufactur*)) AND (orthopaedic). The inclusion criteria were: 1) use of 3D printing in orthopaedics, 2) randomized controlled trials, and 3) studies with participants/patients. Risk of bias was assessed with Cochrane Collaboration Tool and PEDro Score. Pooled analysis was performed. Results. Overall, 21 studies were included in our study with a pooled total of 932 participants. Pooled analysis showed that operating time (p < 0.001), blood loss (p < 0.001), fluoroscopy times (p < 0.001), bone union time (p < 0.001), pain (p = 0.040), accuracy (p < 0.001), and functional scores (p < 0.001) were significantly improved with 3D printing compared to the control group. There were no significant differences in complications. Conclusion. 3D printing is a rapidly developing field in orthopaedics. Our findings show that 3D printing is advantageous in terms of operating time, blood loss, fluoroscopy times, bone union time, pain, accuracy, and function. The use of 3D printing did not increase the risk of complications. Cite this article: Bone Joint Res 2021;10(12):807–819


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 324 - 335
1 Apr 2024
Fontalis A Kayani B Plastow R Giebaly DE Tahmassebi J Haddad IC Chambers A Mancino F Konan S Haddad FS

Aims. Achieving accurate implant positioning and restoring native hip biomechanics are key surgeon-controlled technical objectives in total hip arthroplasty (THA). The primary objective of this study was to compare the reproducibility of the planned preoperative centre of hip rotation (COR) in patients undergoing robotic arm-assisted THA versus conventional THA. Methods. This prospective randomized controlled trial (RCT) included 60 patients with symptomatic hip osteoarthritis undergoing conventional THA (CO THA) versus robotic arm-assisted THA (RO THA). Patients in both arms underwent pre- and postoperative CT scans, and a patient-specific plan was created using the robotic software. The COR, combined offset, acetabular orientation, and leg length discrepancy were measured on the pre- and postoperative CT scanogram at six weeks following surgery. Results. There were no significant differences for any of the baseline characteristics including spinopelvic mobility. The absolute error for achieving the planned horizontal COR was median 1.4 mm (interquartile range (IQR) 0.87 to 3.42) in RO THA versus 4.3 mm (IQR 3 to 6.8; p < 0.001); vertical COR mean 0.91 mm (SD 0.73) in RO THA versus 2.3 mm (SD 1.3; p < 0.001); and combined offset median 2 mm (IQR 0.97 to 5.45) in RO THA versus 3.9 mm (IQR 2 to 7.9; p = 0.019). Improved accuracy was observed with RO THA in achieving the desired acetabular component positioning (root mean square error for anteversion and inclination was 2.6 and 1.3 vs 8.9 and 5.3, repectively) and leg length (mean 0.6 mm vs 1.4 mm; p < 0.001). Patient-reported outcome measures were comparable between the two groups at baseline and one year. Participants in the RO THA group needed fewer physiotherapy sessions postoperatively (median six (IQR 4.5 to 8) vs eight (IQR 6 to 11; p = 0.005). Conclusion. This RCT suggested that robotic-arm assistance in THA was associated with improved accuracy in restoring the native COR, better preservation of the combined offset, leg length correction, and superior accuracy in achieving the desired acetabular component positioning. Further evaluation through long-term and registry data is necessary to assess whether these findings translate into improved implant survival and functional outcomes. Cite this article: Bone Joint J 2024;106-B(4):324–335


Bone & Joint Open
Vol. 4, Issue 8 | Pages 602 - 611
21 Aug 2023
James HK Pattison GTR Griffin J Fisher JD Griffin DR

Aims. To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture. Methods. This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty). Results. Eight female (29%) and 20 male trainees (71%), mean age 29.4 years, performed 317 DHS operations and 243 hemiarthroplasties during ten months of follow-up. Primary analysis was a random effect model with surgeon-level fixed effects of patient condition, patient age, and surgeon experience, with a random intercept for surgeon. Under the intention-to-treat principle, for hemiarthroplasty there was better implant position in favour of cadaveric training, measured by leg length discrepancy ≤ 10 mm (odds ratio (OR) 4.08 (95% confidence interval (CI) 1.17 to 14.22); p = 0.027). There were significantly fewer postoperative blood transfusions required in patients undergoing hemiarthroplasty by cadaveric-trained compared to standard-trained surgeons (OR 6.00 (95% CI 1.83 to 19.69); p = 0.003). For DHS, there was no significant between-group difference in implant position as measured by tip-apex distance ≤ 25 mm (OR 6.47 (95% CI 0.97 to 43.05); p = 0.053). No between-group differences were observed for any secondary clinical outcomes. Conclusion. Trainees randomized to additional cadaveric training performed hip fracture fixation with better implant positioning and fewer postoperative blood transfusions in hemiarthroplasty. This effect, which was previously unknown, may be a consequence of the intervention. Further study is required. Cite this article: Bone Jt Open 2023;4(8):602–611


Aims. Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon. Methods. SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments. Discussion. There is currently no high-quality evidence comparing the clinical and cost effectiveness of the tension suture repair to the traditional tension band wiring currently offered for the internal fixation of displaced fractures of the olecranon. The Simple Olecranon Fracture Fixation Trial (SOFFT) is a randomized controlled trial with sufficient power and design rigour to provide this evidence for the subtype of Mayo grade IIA fractures. Cite this article: Bone Jt Open 2023;4(1):27–37


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1081 - 1088
1 Sep 2022
Behman AL Bradley CS Maddock CL Sharma S Kelley SP

Aims. There is no consensus regarding optimum timing and frequency of ultrasound (US) for monitoring response to Pavlik harness (PH) treatment in developmental dysplasia of the hip (DDH). The purpose of our study was to determine if a limited-frequency hip US assessment had an adverse effect on treatment outcomes compared to traditional comprehensive US monitoring. Methods. This study was a single-centre noninferiority randomized controlled trial. Infants aged under six months whose hips were reduced and centred in the harness at initiation of treatment (stable dysplastic or subluxable), or initially decentred (subluxated or dislocated) but reduced and centred within four weeks of PH treatment, were randomized to our current standard US monitoring protocol (every clinic visit) or to a limited-frequency US protocol (US only at end of treatment). Groups were compared based on α angle and femoral head coverage at the end of PH treatment, acetabular indices, and International Hip Dysplasia Institute (IHDI) grade on one-year follow-up radiographs. Results. Overall, 100 patients were included; 42 patients completed the standard protocol (SP) and 40 completed the limited protocol (LP). There was no significant difference in mean right α angle at the end of treatment (SP 70.0° (SD 3.2°) ; LP 68.7° (SD 2.9°); p = 0.033), nor on the left (SP 69.0° (SD 3.5°); LP 68.1° (SD 3.3°); p = 0.128). There was no significant difference in mean right acetabular index at follow-up (SP 23.1° (SD 4.3°); LP 22.0° (SD 4.1°); p = 0.129), nor on the left (SP 23.3° (SD 4.2°); LP 22.8° (SD 3.9°); p = 0.284). All hips had femoral head coverage of > 50% at end of treatment, and all were IHDI grade 1 at follow-up. In addition, the LP group underwent a 60% reduction in US use once stable. Conclusion. Our study supports reducing the frequency of US assessment during PH treatment of DDH once a hip is reduced and centred. Cite this article: Bone Joint J 2022;104-B(9):1081–1088


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 949 - 956
1 Sep 2024
Matthews PA Scammell BE Coughlin TA Nightingale J Ollivere BJ

Aims. This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme. Methods. A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed. Results. Overall, 130 participants returned their 12-week OMAS questionnaires. The mean OMAS was significantly higher in the EMADE group compared with the immobilized group (62.0 (SD 20.9) vs 48.8 (SD 22.5)), with a clinically meaningful mean difference of 13.2 (95% CI 5.66 to 20.73; p < 0.001). These differences were maintained at week 24, with convergence by week 52. No intervention-related adverse events, including instability, were reported. Conclusion. The EMADE programme demonstrated an accelerated recovery compared to traditional six-week cast immobilization for those who have undergone ORIF surgery to stabilize Weber B (AO44B) ankle fractures. The study found the EMADE intervention to be safe. Cite this article: Bone Joint J 2024;106-B(9):949–956


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 875 - 883
1 Jul 2022
Mills K Wymenga AB van Hellemondt GG Heesterbeek PJC

Aims. Both the femoral and tibial component are usually cemented at revision total knee arthroplasty (rTKA), while stems can be added with either cemented or press-fit (hybrid) fixation. The aim of this study was to compare the long-term stability of rTKA with cemented and press-fitted stems, using radiostereometric analysis (RSA). Methods. This is a follow-up of a randomized controlled trial, initially involving 32 patients, of whom 19 (nine cemented, ten hybrid) were available for follow-up ten years postoperatively, when further RSA measurements were made. Micromotion of the femoral and tibial components was assessed using model-based RSA software (RSAcore). The clinical outcome was evaluated using the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (pain and satisfaction). Results. The median total femoral translation and rotation at ten years were 0.39 mm (interquartile range (IQR) 0.20 to 0.54) and 0.59° (IQR 0.46° to 0.73°) for the cemented group and 0.70 mm (IQR 0.15 to 0.77) and 0.78° (IQR 0.47° to 1.43°) for the hybrid group. For the tibial components this was 0.38 mm (IQR 0.33 to 0.85) and 0.98° (IQR 0.38° to 1.34°) for the cemented group and 0.42 mm (IQR 0.30 to 0.52) and 0.72° (IQR 0.62° to 0.82°) for the hybrid group. None of these values were significantly different between the two groups and there were no significant differences between the clinical scores in the two groups at this time. There was only one re-revision, in the hybrid group, for infection and not for aseptic loosening. Conclusion. These results show good long-term fixation with no difference in micromotion and clinical outcome between fully cemented and hybrid fixation in rTKA, which builds on earlier short- to mid-term results. The patients all had type I or II osseous defects, which may in part explain the good results. Cite this article: Bone Joint J 2022;104-B(7):875–883


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims. The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. Methods. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Results. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. Conclusion. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture. Cite this article: Bone Joint J 2023;105-B(4):382–388


Bone & Joint Open
Vol. 5, Issue 9 | Pages 729 - 735
3 Sep 2024
Charalambous CP Hirst JT Kwaees T Lane S Taylor C Solanki N Maley A Taylor R Howell L Nyangoma S Martin FL Khan M Choudhry MN Shetty V Malik RA

Aims. Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. Methods. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection. Conclusion. The results of this trial will demonstrate if there is a difference in shoulder pain and function after a subacromial space steroid injection between the anterolateral versus posterior approach in patients with subacromial pain syndrome. This will help to guide treatment for patients with subacromial pain syndrome. Cite this article: Bone Jt Open 2024;5(9):729–735


Aims. The aim of this study was to compare the migration of the femoral component, five years postoperatively, between patients with a highly cross-linked polyethylene (HXLPE) insert and those with a conventional polyethylene (PE) insert in an uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary aims included clinical outcomes and patient-reported outcome measures (PROMs). We have previously reported the migration and outcome of the tibial components in these patients. Methods. A double-blinded randomized controlled trial was conducted including 96 TKAs. The migration of the femoral component was measured with radiostereometry (RSA) at three and six months and one, two, and five years postoperatively. PROMs were collected preoperatively and at all periods of follow-up. Results. There was no clinically relevant difference in terms of migration of the femoral component or PROMs between the HXLPE and PE groups. The mean difference in migration (maximum total point motion), five years postopeatively, was 0.04 mm (95% CI -0.06 to 0.16) in favour of the PE group. Conclusion. There was no clinically relevant difference in migration of the femoral component, for up to five years between the two groups. These findings will help to establish a benchmark for future studies on migration of femoral components in TKA. Cite this article: Bone Joint J 2024;106-B(8):826–833


Bone & Joint Open
Vol. 5, Issue 4 | Pages 343 - 349
22 Apr 2024
Franssen M Achten J Appelbe D Costa ML Dutton S Mason J Gould J Gray A Rangan A Sheehan W Singh H Gwilym SE

Aims. Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. Methods. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive. Discussion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between surgical and non-surgical treatment of humeral shaft fractures. Ethical approval has been obtained from East of England – Cambridge Central Research Ethics Committee. Publication is anticipated to occur in 2024. Cite this article: Bone Jt Open 2024;5(4):343–349


Aims. Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance. Methods. We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs. Results. Overall, 139 ankle fractures were fixed by 28 postgraduate year three to five trainee surgeons (mean age 29.4 years; 71% males) during ten months' follow-up. Under the intention-to-treat principle, a technically superior fixation was performed by the cadaveric-trained group compared to the standard-trained group, as measured on the first postoperative radiograph against predefined acceptability thresholds. The cadaveric-trained group used a lower intraoperative dose of radiation than the standard-trained group (mean difference 0.011 Gym. 2. , 95% confidence interval 0.003 to 0.019; p = 0.009). There was no difference in procedure time. Conclusion. Trainees randomized to cadaveric training performed better ankle fracture fixations and irradiated patients less during surgery compared to standard-trained trainees. This effect, which was previously unknown, is likely to be a consequence of the intervention. Further study is required. Cite this article: Bone Jt Open 2023;4(8):594–601


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 619 - 626
1 Apr 2021
Tolk JJ Janssen RPA Haanstra TM van der Steen MC Bierma-Zeinstra SMA Reijman M

Aims. Meeting preoperative expectations is known to be of major influence on postoperative satisfaction after total knee arthroplasty (TKA). Improved management of expectation, resulting in more realistic expectations can potentially lead to higher postoperative satisfaction. The objective of this study was to assess the effect of an additional preoperative education module, addressing realistic expectations for long-term functional recovery, on postoperative satisfaction and expectation fulfilment. Methods. In total, 204 primary TKA patients with osteoarthritis were enrolled in this randomized controlled trial (RCT). Patients were allocated to either usual preoperative education (control group) or usual education plus an additional module on realistic expectations (intervention group). Primary outcome was being very satisfied (numerical rating scale for satisfaction ≥ 8) with the treatment result at 12 months' follow-up. Other outcomes were change in preoperative expectations and postoperative expectation fulfilment. Results. A total of 187 patients (91.7%) were available for analysis at follow-up. In the intention-to-treat analysis, 58.5% (55/94) of patients were very satisfied with the treatment result in the control group, and 69.9% (65/93) of patients in the intervention group (adjusted odds ratio (AOR) 1.72, 95% confidence interval (CI) 0.90 to 3.29). A per-protocol analysis for patients who attended the education session (92.0%, n = 172) showed that 56.9% (49/86) of patients were very satisfied in the control group and 74.4% (61/86) in the intervention group (AOR 2.44, 95% CI 1.21 to 4.91). After preoperative education, the expectation scores in the intervention group were significantly lower (mean difference -6.9 (95% CI -10.2 to -3.6)) and did not alter in the control group (mean difference 0.5 (95% CI -2.9 to 3.9)). Overall, fulfilment of expectations at 12 months was significantly higher in the intervention group (mean difference 11.4% (95% CI 2.3 to 20.5)). Conclusion. Improved preoperative patient education can modify patient expectations, resulting in higher postoperative fulfilment of expectation and higher satisfaction in the group that attended the preoperative education. This is the first RCT to confirm the potential of improved expectation management on satisfaction after TKA. Cite this article: Bone Joint J 2021;103-B(4):619–626


Bone & Joint Open
Vol. 1, Issue 9 | Pages 549 - 555
11 Sep 2020
Sonntag J Landale K Brorson S Harris IA

Aims. The aim of this study was to investigate surgeons’ reported change of treatment preference in response to the results and conclusion from a randomized contolled trial (RCT) and to study patterns of change between subspecialties and nationalities. Methods. Two questionnaires were developed through the Delphi process for this cross-sectional survey of surgical preference. The first questionnaire was sent out before the publication of a RCT and the second questionnaire was sent out after publication. The RCT investigated repair or non-repair of the pronator quadratus (PQ) muscle during volar locked plating of distal radial fractures (DRFs). Overall, 380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied. One hundred surgeons were invited to participate in the second questionnaire. The primary outcome was the proportion of surgeons for whom a treatment change was warranted, who then reported a change of treatment preference following the RCT. Secondary outcomes included the reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year. Results. Of the 100 surgeons invited for the second questionnaire, 74 replied. For the primary outcome, six of 32 surgeons (19%), who usually repaired the PQ muscle and therefore a change of treatment preference was warranted, reported a change of treatment preference based on the RCT publication. Of the secondary outcomes, restoring anatomy was the most common response for repairing the PQ muscle. Conclusion. The majority of the orthopaedic surgeons, where a change of treatment preference was warranted based on the results and conclusion of a RCT, did not report willingness to change their treatment preference. Cite this article: Bone Joint Open 2020;1-9:549–555


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 833 - 843
1 Jul 2022
Kayani B Baawa-Ameyaw J Fontalis A Tahmassebi J Wardle N Middleton R Stephen A Hutchinson J Haddad FS

Aims. This study reports the ten-year wear rates, incidence of osteolysis, clinical outcomes, and complications of a multicentre randomized controlled trial comparing oxidized zirconium (OxZr) versus cobalt-chrome (CoCr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). Methods. Patients undergoing primary THA were recruited from four institutions and prospectively allocated to the following treatment groups: Group A, CoCr femoral head with XLPE liner; Group B, OxZr femoral head with XLPE liner; and Group C, OxZr femoral head with UHMWPE liner. All study patients and assessors recording outcomes were blinded to the treatment groups. The outcomes of 262 study patients were analyzed at ten years’ follow-up. Results. Patients in Group C were associated with increased mean liner wear rates compared to patients in Group A (0.133 mm/yr (SD 0.21) vs 0.031 mm/yr (SD 0.07), respectively; p < 0.001) and Group B (0.133 mm/yr (SD 0.21) vs 0.022 mm/yr (SD 0.05), respectively; p < 0.001) at ten years’ follow-up. Patients in Group C were also associated with increased risk of osteolysis and aseptic loosening requiring revision surgery, compared with patients in Group A (7/133 vs 0/133, respectively; p = 0.007) and Group B (7/133 vs 0/135, respectively; p = 0.007). There was a non-statistically significant trend towards increased mean liner wear rates in Group A compared with Group B (0.031 mm/yr (SD 0.07) vs 0.022 mm/yr (SD 0.05), respectively; p = 0.128). All three groups were statistically comparable preoperatively and at ten years’ follow-up when measuring normalized Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.410), 36-Item Short Form Health Survey (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p = 0.451). Conclusion. The use of UHMWPE was associated with progressively increased annual liner wear rates after THA compared to XLPE. At ten years’ follow-up, the group receiving UHMWPE demonstrated an increased incidence of osteolysis and aseptic loosening requiring revision surgery compared to XLPE. Femoral heads composed of OxZr were associated with trend towards reduced wear rates compared to CoCr, but this did not reach statistical significance and did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two femoral head components. Cite this article: Bone Joint J 2022;104-B(7):833–843