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Bone & Joint Open
Vol. 5, Issue 3 | Pages 210 - 217
13 Mar 2024
Mthethwa PG Marais LC Aldous CM

Aims. The aim of this study is to determine the predictors of overall survival (OS) and predictive factors of poor prognosis of conventional high-grade osteosarcoma of the limbs in a single-centre in South Africa. Methods. We performed a retrospective cross-sectional analysis to identify the prognostic factors that predict the OS of patients with histologically confirmed high-grade conventional osteosarcoma of the limbs over ten years. We employed the Cox proportional regression model and the Kaplan-Meier method for statistical analysis. Results. This study comprised 77 patients at a three-year minimum follow-up. The predictors of poor OS were: the median age of ≤ 19 years (hazard ratio (HR) 0.96; 95% confidence interval (CI) 0.92 to 0.99; p = 0.021); median duration of symptoms ≥ five months (HR 0.91; 95% CI 0.83 to 0.99; p < 0.037); metastasis at diagnosis (i.e. Enneking stage III) (HR 3.33; 95% CI 1.81 to 6.00; p < 0.001); increased alkaline phosphatase (HR 3.28; 95% CI 1.33 to 8.11; p < 0.010); palliative treatment (HR 7.27; 95% CI 2.69 to 19.70); p < 0.001); and amputation (HR 3.71; 95% CI 1.12 to 12.25; p < 0.032). In contrast, definitive surgery (HR 0.11; 95% CI 0.03 to 0.38; p < 0.001) and curative treatment (HR 0.18; 95% CI 0.10 to 0.33; p < 0.001) were a protective factor. The Kaplan-Meier median survival time was 24 months, with OS of 57.1% at the three years. The projected five-year event-free survival was 10.3% and OS of 29.8% (HR 0.76; 95% CI 0.52 to 1.12; p = 0.128). Conclusion. In this series of high-grade conventional osteosarcoma of the appendicular skeleton from South Africa, 58.4% (n = 45) had detectable metastases at presentation; hence, an impoverished OS of five years was 29.8%. Large-scale future research is needed to validate our results. Cite this article: Bone Jt Open 2024;5(3):210–217


Bone & Joint Open
Vol. 2, Issue 9 | Pages 705 - 709
1 Sep 2021
Wright J Timms A Fugazzotto S Goodier D Calder P

Aims. Patients undergoing limb reconstruction surgery often face a challenging and lengthy process to complete their treatment journey. The majority of existing outcome measures do not adequately capture the patient-reported outcomes relevant to this patient group in a single measure. Following a previous systematic review, the Stanmore Limb Reconstruction Score (SLRS) was designed with the intent to address this need for an effective instrument to measure patient-reported outcomes in limb reconstruction patients. We aim to assess the face validity of this score in a pilot study. Methods. The SLRS was designed following structured interviews with several groups including patients who have undergone limb reconstruction surgery, limb reconstruction surgeons, specialist nurses, and physiotherapists. This has subsequently undergone further adjustment for language and clarity. The score was then trialled on ten patients who had undergone limb reconstruction surgery, with subsequent structured questioning to understand the perceived suitability of the score. Results. Ten patients completed the score and the subsequent structured interview. Considering the tool as a whole, 100% of respondents felt the score to be comprehensible, relevant, and comprehensive regarding the areas that were important to a patient undergoing limb reconstruction surgery. For individual questions, on a five-point Likert scale, importance/relevance was reported as a mean of 4.78 (4.3 to 5.0), with ability to understand rated as 4.92 (4.7 to 5.0) suggesting high levels of relevance and comprehension. Flesch-Kincaid reading grade level was calculated as 5.2 (10 to 11 years old). Conclusion. The current SLRS has been shown to have acceptable scores from a patient sample regarding relevance, comprehensibility, and comprehensiveness. This suggests face validity, however further testing required and is ongoing in a larger cohort of patients to determine the reliability, responsiveness, precision, and criterion validity of the score in this patient group. Cite this article: Bone Jt Open 2021;2(9):705–709


Bone & Joint Open
Vol. 5, Issue 4 | Pages 317 - 323
18 Apr 2024
Zhu X Hu J Lin J Song G Xu H Lu J Tang Q Wang J

Aims. The aim of this study was to investigate the safety and efficacy of 3D-printed modular prostheses in patients who underwent joint-sparing limb salvage surgery (JSLSS) for malignant femoral diaphyseal bone tumours. Methods. We retrospectively reviewed 17 patients (13 males and four females) with femoral diaphyseal tumours who underwent JSLSS in our hospital. Results. In all, 17 patients with locally aggressive bone tumours (Enneking stage IIB) located in the femoral shaft underwent JSLSS and reconstruction with 3D-printed modular prostheses between January 2020 and June 2022. The median surgical time was 153 minutes (interquartile range (IQR) 117 to 248), and the median estimated blood loss was 200ml (IQR 125 to 400). Osteosarcoma was the most common pathological type (n = 12; 70.6%). The mean osteotomy length was 197.53 mm (SD 12.34), and the median follow-up was 25 months (IQR 19 to 38). Two patients experienced local recurrence and three developed distant metastases. Postoperative complications included wound infection in one patient and screw loosening in another, both of which were treated successfully with revision surgery. The median Musculoskeletal Tumor Society score at the final follow-up was 28 (IQR 27 to 28). Conclusion. The 3D-printed modular prosthesis is a reliable and feasible reconstruction option for patients with malignant femoral diaphyseal tumours. It helps to improve the limb salvage rate, restore limb function, and achieve better short-term effectiveness. Cite this article: Bone Jt Open 2024;5(4):317–323


Bone & Joint Open
Vol. 5, Issue 2 | Pages 109 - 116
8 Feb 2024
Corban LE van de Graaf VA Chen DB Wood JA Diwan AD MacDessi SJ

Aims

While mechanical alignment (MA) is the traditional technique in total knee arthroplasty (TKA), its potential for altering constitutional alignment remains poorly understood. This study aimed to quantify unintentional changes to constitutional coronal alignment and joint line obliquity (JLO) resulting from MA.

Methods

A retrospective cohort study was undertaken of 700 primary MA TKAs (643 patients) performed between 2014 and 2017. Lateral distal femoral and medial proximal tibial angles were measured pre- and postoperatively to calculate the arithmetic hip-knee-ankle angle (aHKA), JLO, and Coronal Plane Alignment of the Knee (CPAK) phenotypes. The primary outcome was the magnitude and direction of aHKA, JLO, and CPAK alterations.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 146 - 157
7 Mar 2023
Camilleri-Brennan J James S McDaid C Adamson J Jones K O'Carroll G Akhter Z Eltayeb M Sharma H

Aims. Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. Methods. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy. Results. A total of 3,303 records were screened, of which 99 studies were included. Most studies were case series (77/99; 78%) and assessed one method of reconstruction (68/99; 69%). A total of 511 outcomes were reported, which were grouped into 58 distinct outcomes. Overall, 143/511 of all outcomes (28%) were provided with a clear, in-text definition, and 231 outcomes (45%) had details reported of how and when they were measured. The most commonly reported outcome was ‘recurrence of osteomyelitis’ (62; 12%). The single-most patient-reported outcome measure was ‘pain’. Conclusion. This study has highlighted significant inconsistencies in the defining, reporting, and measuring of outcomes across studies investigating surgical management for chronic osteomyelitis of the lower limb in adults. Future studies should clearly report complete details of how outcomes are defined and measured, including timing. The development of a standardized core outcome set would be of significant benefit in order to allow evidence synthesis and comparison across studies. Cite this article: Bone Jt Open 2023;4(3):146–157


Bone & Joint Open
Vol. 2, Issue 6 | Pages 397 - 404
1 Jun 2021
Begum FA Kayani B Magan AA Chang JS Haddad FS

Limb alignment in total knee arthroplasty (TKA) influences periarticular soft-tissue tension, biomechanics through knee flexion, and implant survival. Despite this, there is no uniform consensus on the optimal alignment technique for TKA. Neutral mechanical alignment facilitates knee flexion and symmetrical component wear but forces the limb into an unnatural position that alters native knee kinematics through the arc of knee flexion. Kinematic alignment aims to restore native limb alignment, but the safe ranges with this technique remain uncertain and the effects of this alignment technique on component survivorship remain unknown. Anatomical alignment aims to restore predisease limb alignment and knee geometry, but existing studies using this technique are based on cadaveric specimens or clinical trials with limited follow-up times. Functional alignment aims to restore the native plane and obliquity of the joint by manipulating implant positioning while limiting soft tissue releases, but the results of high-quality studies with long-term outcomes are still awaited. The drawbacks of existing studies on alignment include the use of surgical techniques with limited accuracy and reproducibility of achieving the planned alignment, poor correlation of intraoperative data to long-term functional outcomes and implant survivorship, and a paucity of studies on the safe ranges of limb alignment. Further studies on alignment in TKA should use surgical adjuncts (e.g. robotic technology) to help execute the planned alignment with improved accuracy, include intraoperative assessments of knee biomechanics and periarticular soft-tissue tension, and correlate alignment to long-term functional outcomes and survivorship


Bone & Joint Open
Vol. 2, Issue 5 | Pages 351 - 358
27 May 2021
Griffiths-Jones W Chen DB Harris IA Bellemans J MacDessi SJ

Aims. Once knee arthritis and deformity have occurred, it is currently not known how to determine a patient’s constitutional (pre-arthritic) limb alignment. The purpose of this study was to describe and validate the arithmetic hip-knee-ankle (aHKA) algorithm as a straightforward method for preoperative planning and intraoperative restoration of the constitutional limb alignment in total knee arthroplasty (TKA). Methods. A comparative cross-sectional, radiological study was undertaken of 500 normal knees and 500 arthritic knees undergoing TKA. By definition, the aHKA algorithm subtracts the lateral distal femoral angle (LDFA) from the medial proximal tibial angle (MPTA). The mechanical HKA (mHKA) of the normal group was compared to the mHKA of the arthritic group to examine the difference, specifically related to deformity in the latter. The mHKA and aHKA were then compared in the normal group to assess for differences related to joint line convergence. Lastly, the aHKA of both the normal and arthritic groups were compared to test the hypothesis that the aHKA can estimate the constitutional alignment of the limb by sharing a similar centrality and distribution with the normal population. Results. There was a significant difference in means and distributions of the mHKA of the normal group compared to the arthritic group (mean -1.33° (SD 2.34°) vs mean -2.88° (SD 7.39°) respectively; p < 0.001). However, there was no significant difference between normal and arthritic groups using the aHKA (mean -0.87° (SD 2.54°) vs mean -0.77° (SD 2.84°) respectively; p = 0.550). There was no significant difference in the MPTA and LDFA between the normal and arthritic groups. Conclusion. The arithmetic HKA effectively estimated the constitutional alignment of the lower limb after the onset of arthritis in this cross-sectional population-based analysis. This finding is of significant importance to surgeons aiming to restore the constitutional alignment of the lower limb during TKA. Cite this article: Bone Jt Open 2021;2(5):351–358


Aims. To evaluate mid-to long-term patient-reported outcome measures (PROMs) of endoprosthetic reconstruction after resection of malignant tumours arising around the knee, and to investigate the risk factors for unfavourable PROMs. Methods. The medical records of 75 patients who underwent surgery between 2000 and 2020 were retrospectively reviewed, and 44 patients who were alive and available for follow-up (at a mean of 9.7 years postoperatively) were included in the study. Leg length discrepancy was measured on whole-leg radiographs, and functional assessment was performed with PROMs (Toronto Extremity Salvage Score (TESS) and Comprehensive Outcome Measure for Musculoskeletal Oncology Lower Extremity (COMMON-LE)) with two different aspects. The thresholds for unfavourable PROMs were determined using anchor questions regarding satisfaction, and the risk factors for unfavourable PROMs were investigated. Results. The thresholds for favourable TESS and COMMON were 64.8 and 70.4 points, respectively. Multivariate analysis showed that age at surgery (p = 0.004) and postoperative leg length discrepancy (p = 0.043) were significant risk factors for unfavourable TESS results, while age at surgery (p < 0.001) was a significant risk factor for unfavourable COMMON-LE results. Following receiver operating characteristic analysis, the threshold for both TESS and COMMON-LE was 29 years of age at surgery. Additionally, a leg length discrepancy of 8.2 mm was the threshold for unfavourable TESS. Conclusion. Patients aged > 29 years at the time of surgery require appropriate preoperative counselling and adequate postoperative physical and socioemotional support. Reconstruction equivalent to the length of the resected bone can reduce the risk of functional disabilities in daily living. Cite this article: Bone Jt Open 2023;4(12):906–913


Bone & Joint Open
Vol. 3, Issue 8 | Pages 656 - 665
23 Aug 2022
Tran T McEwen P Peng Y Trivett A Steele R Donnelly W Clark G

Aims. The mid-term results of kinematic alignment (KA) for total knee arthroplasty (TKA) using image derived instrumentation (IDI) have not been reported in detail, and questions remain regarding ligamentous stability and revisions. This paper aims to address the following: 1) what is the distribution of alignment of KA TKAs using IDI; 2) is a TKA alignment category associated with increased risk of failure or poor patient outcomes; 3) does extending limb alignment lead to changes in soft-tissue laxity; and 4) what is the five-year survivorship and outcomes of KA TKA using IDI?. Methods. A prospective, multicentre, trial enrolled 100 patients undergoing KA TKA using IDI, with follow-up to five years. Alignment measures were conducted pre- and postoperatively to assess constitutional alignment and final implant position. Patient-reported outcome measures (PROMs) of pain and function were also included. The Australian Orthopaedic Association National Joint Arthroplasty Registry was used to assess survivorship. Results. The postoperative HKA distribution varied from 9° varus to 11° valgus. All PROMs showed statistical improvements at one year (p < 0.001), with further improvements at five years for Knee Osteoarthritis Outcome Score symptoms (p = 0.041) and Forgotten Joint Score (p = 0.011). Correlation analysis showed no difference (p = 0.610) between the hip-knee-ankle and joint line congruence angle at one and five years. Sub-group analysis showed no difference in PROMs for patients placed within 3° of neutral compared to those placed > 3°. There were no revisions for tibial loosening; however, there were reports of a higher incidence of poor patella tracking and patellofemoral stiffness. Conclusion. PROMs were not impacted by postoperative alignment category. Ligamentous stability was maintained at five years with joint line obliquity. There were no revisions for tibial loosening despite a significant portion of tibiae placed in varus; however, KA executed with IDI resulted in a higher than anticipated rate of patella complications. Cite this article: Bone Jt Open 2022;3(8):656–665


Bone & Joint Open
Vol. 5, Issue 3 | Pages 236 - 242
22 Mar 2024
Guryel E McEwan J Qureshi AA Robertson A Ahluwalia R

Aims. Ankle fractures are common injuries and the third most common fragility fracture. In all, 40% of ankle fractures in the frail are open and represent a complex clinical scenario, with morbidity and mortality rates similar to hip fracture patients. They have a higher risk of complications, such as wound infections, malunion, hospital-acquired infections, pressure sores, veno-thromboembolic events, and significant sarcopaenia from prolonged bed rest. Methods. A modified Delphi method was used and a group of experts with a vested interest in best practice were invited from the British Foot and Ankle Society (BOFAS), British Orthopaedic Association (BOA), Orthopaedic Trauma Society (OTS), British Association of Plastic & Reconstructive Surgeons (BAPRAS), British Geriatric Society (BGS), and the British Limb Reconstruction Society (BLRS). Results. In the first stage, there were 36 respondents to the survey, with over 70% stating their unit treats more than 20 such cases per year. There was a 50:50 split regarding if the timing of surgery should be within 36 hours, as per the hip fracture guidelines, or 72 hours, as per the open fracture guidelines. Overall, 75% would attempt primary wound closure and 25% would utilize a local flap. There was no orthopaedic agreement on fixation, and 75% would permit weightbearing immediately. In the second stage, performed at the BLRS meeting, experts discussed the survey results and agreed upon a consensus for the management of open elderly ankle fractures. Conclusion. A mutually agreed consensus from the expert panel was reached to enable the best practice for the management of patients with frailty with an open ankle fracture: 1) all units managing lower limb fragility fractures should do so through a cohorted multidisciplinary pathway. This pathway should follow the standards laid down in the "care of the older or frail orthopaedic trauma patient" British Orthopaedic Association Standards for Trauma and Orthopaedics (BOAST) guideline. These patients have low bone density, and we should recommend full falls and bone health assessment; 2) all open lower limb fragility fractures should be treated in a single stage within 24 hours of injury if possible; 3) all patients with fragility fractures of the lower limb should be considered for mobilisation on the day following surgery; 4) all patients with lower limb open fragility fractures should be considered for tissue sparing, with judicious debridement as a default; 5) all patients with open lower limb fragility fractures should be managed by a consultant plastic surgeon with primary closure wherever possible; and 6) the method of fixation must allow for immediate unrestricted weightbearing. Cite this article: Bone Jt Open 2024;5(3):236–242


Bone & Joint Open
Vol. 4, Issue 11 | Pages 817 - 824
1 Nov 2023
Filis P Varvarousis D Ntritsos G Dimopoulos D Filis N Giannakeas N Korompilias A Ploumis A

Aims. The standard of surgical treatment for lower limb neoplasms had been characterized by highly interventional techniques, leading to severe kinetic impairment of the patients and incidences of phantom pain. Rotationplasty had arisen as a potent limb salvage treatment option for young cancer patients with lower limb bone tumours, but its impact on the gait through comparative studies still remains unclear several years after the introduction of the procedure. The aim of this study is to assess the effect of rotationplasty on gait parameters measured by gait analysis compared to healthy individuals. Methods. The MEDLINE, Scopus, and Cochrane databases were systematically searched without time restriction until 10 January 2022 for eligible studies. Gait parameters measured by gait analysis were the outcomes of interest. Results. Three studies were eligible for analyses. Compared to healthy individuals, rotationplasty significantly decreased gait velocity (-1.45 cm/sec; 95% confidence interval (CI) -1.98 to -0.93; p < 0.001), stride length (-1.20 cm; 95% CI -2.31 to -0.09; p < 0.001), cadence (-0.83 stride/min; 95% (CI -1.29 to -0.36; p < 0.001), and non-significantly increased cycle time (0.54 sec; 95% CI -0.42 to 1.51; p = 0.184). Conclusion. Rotationplasty is a valid option for the management of lower limb bone tumours in young cancer patients. Larger studies, with high patient accrual, refined surgical techniques, and well planned rehabilitation strategies, are required to further improve the reported outcomes of this procedure. Cite this article: Bone Jt Open 2023;4(11):817–824


Bone & Joint Open
Vol. 3, Issue 5 | Pages 415 - 422
17 May 2022
Hillier-Smith R Paton B

Aims. Avulsion of the proximal hamstring tendon origin can result in significant functional impairment, with surgical re-attachment of the tendons becoming an increasingly recognized treatment. The aim of this study was to assess the outcomes of surgical management of proximal hamstring tendon avulsions, and to compare the results between acute and chronic repairs, as well as between partial and complete injuries. Methods. PubMed, CINAHL, SPORTdiscuss, Cochrane Library, EMBASE, and Web of Science were searched. Studies were screened and quality assessed. Results. In all, 35 studies (1,530 surgically-repaired hamstrings) were included. Mean age at time of repair was 44.7 years (12 to 78). A total of 846 tears were acute, and 684 were chronic, with 520 tears being defined as partial, and 916 as complete. Overall, 92.6% of patients were satisfied with the outcome of their surgery. Mean Lower Extremity Functional Score was 74.7, and was significantly higher in the partial injury group. Mean postoperative hamstring strength was 87.0% of the uninjured limb, and was higher in the partial group. The return to sport (RTS) rate was 84.5%, averaging at a return of 6.5 months. RTS was quicker in the acute group. Re-rupture rate was 1.2% overall, and was lower in the acute group. Sciatic nerve dysfunction rate was 3.5% overall, and lower in the acute group (p < 0.05 in all cases). Conclusion. Surgical treatment results in high satisfaction rates, with good functional outcomes, restoration of muscle strength, and RTS. Partial injuries could expect a higher functional outcome and muscle strength return. Acute repairs result in a quicker RTS with a reduced rate of re-rupture and sciatic nerve dysfunction. Cite this article: Bone Jt Open 2022;3(5):415–422


Bone & Joint Open
Vol. 3, Issue 4 | Pages 314 - 320
7 Apr 2022
Malhotra R Batra S Sugumar PA Gautam D

Aims. Adult patients with history of childhood infection pose a surgical challenge for total hip arthroplasty (THA) due to distorted bony anatomy, soft-tissue contractures, risk of reinfection, and relatively younger age. Therefore, the purpose of the present study was to determine clinical outcome, reinfection rate, and complications in patients with septic sequelae after THA. Methods. A retrospective analysis was conducted of 91 cementless THAs (57 male and 34 female) performed between 2008 and 2017 in patients who had history of hip infection during childhood. Clinical outcome was measured using Harris Hip Score (HHS) and Modified Merle d’Aubigne and Postel (MAP) score, and quality of life (QOL) using 12-Item Short Form Health Survey Questionnaire (SF-12) components: Physical Component Score (PCS) and Mental Component Score (MCS); limb length discrepancy (LLD) and radiological assessment of the prosthesis was performed at the latest follow-up. Reinfection and revision surgery after THA for any reason was documented. Results. There was significant improvement in HHS, Modified Merle d’Aubigne Postel hip score, and QOL index SF 12-PCS and MCS (p < 0.001) and there was no case of reinfection reported during the follow-up. The minimum follow-up for the study was three years with a mean of 6.5 (SD 2.3; 3 to 12). LLD decreased from a mean of 3.3 cm (SD 1) to 0.9 cm (SD 0.8) during follow-up. One patient required revision surgery for femoral component loosening. Kaplan-Meier survival analysis estimated revision-free survivorship of 100% at the end of five years and 96.9% (95% confidence interval 79.8 to 99.6) at the end of ten years. Conclusion. We found that cementless THA results in good to excellent functional outcomes in patients with a prior history of childhood infection. There is an exceedingly low rate of risk of reinfection in these patients, even though complications are not uncommon. Cite this article: Bone Jt Open 2022;3(4):314–320


Aims. Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures. Methods. A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout. Results. Six studies involving 353 fractures were identified from 3,078 records. Following ROB2 assessment, five studies (representing 338 fractures) were appropriate for meta-analysis. Primary outcomes showed non-significant reductions in articular depression at immediate postoperative (mean difference -0.45 mm, p = 0.25, 95%confidence interval (CI) -1.21 to 0.31, I. 2. = 0%) and long-term (> six months, standard mean difference -0.56, p = 0.09, 95% CI -1.20 to 0.08, I. 2. = 73%) follow-up in synthetic bone grafts. Secondary outcomes included mechanical alignment, limb functionality, and defect site pain at long-term follow-up, perioperative blood loss, duration of surgery, occurrence of surgical site infections, and secondary surgery. Mean blood loss was lower (90.08 ml, p < 0.001, 95% CI 41.49 to 138.67) and surgery was shorter (16.17 minutes, p = 0.04, 95% CI 0.39 to 31.94) in synthetic treatment groups. All other secondary measures were statistically comparable. Conclusion. All studies reported similar methodologies and patient populations; however, imprecision may have arisen through performance variation. These findings supersede previous literature and indicate that, despite perceived biological advantages, autologous bone grafting does not demonstrate superiority to synthetic grafts. When selecting a void filler, surgeons should consider patient comorbidity, environmental and societal factors in provision, and perioperative and postoperative care provision. Cite this article: Bone Jt Open 2022;3(3):218–228


Bone & Joint Open
Vol. 3, Issue 4 | Pages 340 - 347
22 Apr 2022
Winkler T Costa ML Ofir R Parolini O Geissler S Volk H Eder C

Aims. The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. Methods. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 10. 6. PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%. Conclusion. The HIPGEN study assesses the efficacy, safety, and tolerability of intramuscular PLX-PAD administration for the treatment of muscle injury following arthroplasty for hip fracture. It is the first phase III study to investigate the effect of an allogeneic cell therapy on improved mobilization after hip fracture, an aspect which is in sore need of addressing for the improvement in standard of care treatment for patients with FNF. Cite this article: Bone Jt Open 2022;3(4):340–347


Aims. Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. Methods. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately. Conclusion. This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results. Cite this article: Bone Joint Open 2020;1-6:205–213


Bone & Joint Open
Vol. 1, Issue 6 | Pages 236 - 244
11 Jun 2020
Verstraete MA Moore RE Roche M Conditt MA

Aims. The use of technology to assess balance and alignment during total knee surgery can provide an overload of numerical data to the surgeon. Meanwhile, this quantification holds the potential to clarify and guide the surgeon through the surgical decision process when selecting the appropriate bone recut or soft tissue adjustment when balancing a total knee. Therefore, this paper evaluates the potential of deploying supervised machine learning (ML) models to select a surgical correction based on patient-specific intra-operative assessments. Methods. Based on a clinical series of 479 primary total knees and 1,305 associated surgical decisions, various ML models were developed. These models identified the indicated surgical decision based on available, intra-operative alignment, and tibiofemoral load data. Results. With an associated area under the receiver-operator curve ranging between 0.75 and 0.98, the optimized ML models resulted in good to excellent predictions. The best performing model used a random forest approach while considering both alignment and intra-articular load readings. Conclusion. The presented model has the potential to make experience available to surgeons adopting new technology, bringing expert opinion in their operating theatre, but also provides insight in the surgical decision process. More specifically, these promising outcomes indicated the relevance of considering the overall limb alignment in the coronal and sagittal plane to identify the appropriate surgical decision


Bone & Joint Open
Vol. 5, Issue 7 | Pages 565 - 569
9 Jul 2024
Britten S

Two discrete legal factors enable the surgeon to treat an injured patient the fully informed, autonomous consent of the adult patient with capacity via civil law; and the medical exception to the criminal law. This article discusses current concepts in consent in trauma; and also considers the perhaps less well known medical exception to the Offences against the Person Act 1861, which exempts surgeons from criminal liability as long as they provide ‘proper medical treatment’.

Cite this article: Bone Jt Open 2024;5(7):565–569.


Bone & Joint Open
Vol. 5, Issue 5 | Pages 374 - 384
1 May 2024
Bensa A Sangiorgio A Deabate L Illuminati A Pompa B Filardo G

Aims

Robotic-assisted unicompartmental knee arthroplasty (R-UKA) has been proposed as an approach to improve the results of the conventional manual UKA (C-UKA). The aim of this meta-analysis was to analyze the studies comparing R-UKA and C-UKA in terms of clinical outcomes, radiological results, operating time, complications, and revisions.

Methods

The literature search was conducted on three databases (PubMed, Cochrane, and Web of Science) on 20 February 2024 according to the guidelines for Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Inclusion criteria were comparative studies, written in the English language, with no time limitations, on the comparison of R-UKA and C-UKA. The quality of each article was assessed using the Downs and Black Checklist for Measuring Quality.


Bone & Joint Open
Vol. 1, Issue 9 | Pages 556 - 561
14 Sep 2020
Clough TM Shah N Divecha H Talwalkar S

Aims. The exact risk to patients undergoing surgery who develop COVID-19 is not yet fully known. This study aims to provide the current data to allow adequate consent regarding the risks of post-surgery COVID-19 infection and subsequent COVID-19-related mortality. Methods. All orthopaedic trauma cases at the Wrightington Wigan and Leigh NHS Foundation Trust from ‘lockdown’ (23 March 2020) to date (15 June 2020) were collated and split into three groups. Adult ambulatory trauma surgeries (upper limb trauma, ankle fracture, tibial plateau fracture) and regional-specific referrals (periprosthetic hip fracture) were performed at a stand-alone elective site that accepted COVID-19-negative patients. Neck of femur fractures (NOFF) and all remaining non-NOFF (paediatric trauma, long bone injury) surgeries were performed at an acute site hospital (mixed green/blue site). Patients were swabbed for COVID-19 before surgery on both sites. Age, sex, nature of surgery, American Society of Anaesthesiologists (ASA) grade, associated comorbidity, length of stay, development of post-surgical COVID-19 infection, and post-surgical COVID-19-related deaths were collected. Results. At the elective site, 225 patients underwent orthopaedic trauma surgery; two became COVID-19-positive (0.9%) in the immediate perioperative period, neither of which was fatal. At the acute site, 93 patients underwent non-NOFF trauma surgery, of whom six became COVID-19-positive (6.5%) and three died. A further 84 patients underwent NOFF surgery, seven becoming COVID-19 positive (8.3%) and five died. Conclusion. At the elective site, the rate of COVID-19 infection following orthopaedic trauma surgery was low, at 0.9%. At the acute mixed site (typical district general hospital), for non-NOFF surgery there was a 6.5% incidence of post-surgical COVID-19 infection (seven-fold higher risk) with 50% COVID-19 mortality; for NOFF surgery, there was an 8.3% incidence of post-surgical COVID-19 infection, with 71% COVID-19 mortality. This is likely to have significance when planning a resumption of elective orthopaedic surgery and for consent to the patient. Cite this article: Bone Joint Open 2020;1-9:556–561