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Bone & Joint Open
Vol. 4, Issue 5 | Pages 370 - 377
19 May 2023
Comeau-Gauthier M Bzovsky S Axelrod D Poolman RW Frihagen F Bhandari M Schemitsch E Sprague S

Aims. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA). Methods. This study is a secondary analysis of patients aged 50 years or older with a displaced femoral neck fracture who were enrolled in the HEALTH trial and underwent monopolar and bipolar HA. Scores from the Western Ontario and McMaster University Arthritis Index (WOMAC) and 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) and (MCS) were compared between the two HA groups using a propensity score-weighted analysis. Results. Of 746 HAs performed in the HEALTH trial, 404 were bipolar prostheses and 342 were unipolar. After propensity score weighting, adequate balance between the bipolar and unipolar groups was obtained as shown by standardized mean differences less than 0.1 for each covariable. A total of 24 months after HA, the total WOMAC score and its subcomponents showed no statistically significant difference between the unipolar and bipolar groups. Similarly, no statistically significant difference was found in the PCS and MCS scores of the SF-12 questionnaire. In participants aged 70 years and younger, no difference was found in any of the functional outcomes. Conclusion. From the results of this study, the use of bipolar HA over unipolar design does not provide superior functional outcomes at 24 months postoperatively. The theoretical advantage of reduced acetabular wear with bipolar designs does not appear to influence functional outcomes in the first two years postoperatively. Cite this article: Bone Jt Open 2023;4(5):370–377


Bone & Joint Open
Vol. 4, Issue 3 | Pages 168 - 181
14 Mar 2023
Dijkstra H Oosterhoff JHF van de Kuit A IJpma FFA Schwab JH Poolman RW Sprague S Bzovsky S Bhandari M Swiontkowski M Schemitsch EH Doornberg JN Hendrickx LAM

Aims. To develop prediction models using machine-learning (ML) algorithms for 90-day and one-year mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip fracture Evaluation with Alternatives of Total Hip arthroplasty versus Hemiarthroplasty (HEALTH) and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trials. Methods. This study included 2,388 patients from the HEALTH and FAITH trials, with 90-day and one-year mortality proportions of 3.0% (71/2,388) and 6.4% (153/2,388), respectively. The mean age was 75.9 years (SD 10.8) and 65.9% of patients (1,574/2,388) were female. The algorithms included patient and injury characteristics. Six algorithms were developed, internally validated and evaluated across discrimination (c-statistic; discriminative ability between those with risk of mortality and those without), calibration (observed outcome compared to the predicted probability), and the Brier score (composite of discrimination and calibration). Results. The developed algorithms distinguished between patients at high and low risk for 90-day and one-year mortality. The penalized logistic regression algorithm had the best performance metrics for both 90-day (c-statistic 0.80, calibration slope 0.95, calibration intercept -0.06, and Brier score 0.039) and one-year (c-statistic 0.76, calibration slope 0.86, calibration intercept -0.20, and Brier score 0.074) mortality prediction in the hold-out set. Conclusion. Using high-quality data, the ML-based prediction models accurately predicted 90-day and one-year mortality in patients aged 50 years or older with a FNF. The final models must be externally validated to assess generalizability to other populations, and prospectively evaluated in the process of shared decision-making. Cite this article: Bone Jt Open 2023;4(3):168–181


Bone & Joint Open
Vol. 2, Issue 11 | Pages 909 - 920
10 Nov 2021
Smith T Clark L Khoury R Man M Hanson S Welsh A Clark A Hopewell S Pfeiffer K Logan P Crotty M Costa M Lamb SE

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


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1052 - 1059
1 Oct 2023
El-Sahoury JAN Kjærgaard K Ovesen O Hofbauer C Overgaard S Ding M

Aims. The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA). Methods. A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size. Results. A total of 116 patients participated, of whom 77 were male. The median ages of the vE-PE 32 mm and 36 mm groups were 65 (interquartile range (IQR) 57 to 67) and 63 years (IQR 56 to 66), respectively, and of the XLPE 32 mm and 36 mm groups were 64 (IQR 58 to 66) and 61 years (IQR 54 to 66), respectively. Mean total head penetration was significantly lower into vE-PE acetabular liner groups than into XLPE acetabular liner groups (-0.219 mm (95% confidence interval -0.348 to -0.090); p = 0.001). There were no differences in wear according to head size, acetabular component migration, or PROMs, except for UCLA. There were no cases of aseptic loosening or failures requiring revision at long-term follow-up. Conclusion. Significantly lower wear was observed in vE-PE acetabular liners than in XLPE acetabular liners. No difference in wear was observed between different head size or PROMs except for the UCLA at ten years. Cite this article: Bone Joint J 2023;105-B(10):1052–1059


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1297 - 1302
3 Oct 2020
Kurosaka K Tsukada S Ogawa H Nishino M Nakayama T Yoshiya S Hirasawa N

Aims. Although periarticular injection plays an important role in multimodal pain management following total hip arthroplasty (THA), there is no consensus on the optimal composition of the injection. In particular, it is not clear whether the addition of a corticosteroid improves the pain relief achieved nor whether it is associated with more complications than are observed without corticosteroid. The aim of this study was to quantify the safety and effectiveness of cortocosteroid use in periarticular injection during THA. Methods. We conducted a prospective, two-arm, parallel-group, randomized controlled trial involving patients scheduled for unilateral THA. A total of 187 patients were randomly assigned to receive periarticular injection containing either a corticosteroid (CS group) or without corticosteroid (no-CS group). Other perioperative interventions were identical for all patients. The primary outcome was postoperative pain at rest during the initial 24 hours after surgery. Pain score was recorded every three hours until 24 hours using a 100 mm visual analogue scale (VAS). The primary outcome was assessed based on the area under the curve (AUC). Results. The CS group had a significantly lower AUC postoperatively at 0 to 24 hours compared to the no-CS group (AUC of VAS score at rest 550 ± 362 vs 392 ± 320, respectively; mean difference 158 mm; 95% confidence interval (CI) 58 to 257; p = 0.0021). In point-by-point evaluation, the CS group had significantly lower VAS scores at 12, 15, 18, 21, 24, and 48 hours. There were no significant differences in complication rates, including surgical site infection, between the two groups. Conclusion. The addition of corticosteroid to periarticular injections reduces postoperative pain without increasing complication rate following THA. Cite this article: Bone Joint J 2020;102-B(10):1297–1302


Objectives. The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. Recent guidance from The National Institute for Health and Clinical Excellence (NICE) states that research into the clinical and cost effectiveness of total hip arthroplasty (THA) as a treatment for hip fracture is a priority. We asked the question: can a trial investigating THA for hip fracture currently be delivered in the NHS?. Methods. We performed a contemporaneous process evaluation that provides a context for the interpretation of the findings of WHiTE Two – a randomised study of THA for hip fracture. We developed a mixed methods approach to situate the trial centre within the context of wider United Kingdom clinical practice. We focused on fidelity, implementation, acceptability and feasibility of both the trial processes and interventions to stakeholder groups, such as healthcare providers and patients. Results. We have shown that patients are willing to participate in this type of research and that surgeons value being part of a team that has a strong research ethos. However, surgical practice does not currently reflect NICE guidance. Current models of service delivery for hip fractures are unlikely to be able to provide timely total hip arthroplasty for suitable patients. Conclusions. Further observational research should be conducted to define the population of interest before future interventional studies are performed. Cite this article: C. Huxley, J. Achten, M. L. Costa, F. Griffiths, X. L. Griffin. A process evaluation of the WHiTE Two trial comparing total hip arthroplasty with and without dual mobility component in the treatment of displaced intracapsular fractures of the proximal femur: Can a trial investigating total hip arthroplasty for hip fracture be delivered in the NHS? Bone Joint Res 2016;5:444–452. DOI: 10.1302/2046-3758.510.BJR-2015-0008.R1


Bone & Joint Open
Vol. 1, Issue 10 | Pages 653 - 662
20 Oct 2020
Rahman L Ibrahim MS Somerville L Teeter MG Naudie DD McCalden RW

Aims. To compare the in vivo long-term fixation achieved by two acetabular components with different porous ingrowth surfaces using radiostereometric analysis (RSA). Methods. This was a minimum ten-year follow-up of a prospective randomized trial of 62 hips with two different porous ingrowth acetabular components. RSA exams had previously been acquired through two years of follow-up. Patients returned for RSA examination at a minimum of ten years. In addition, radiological appearance of these acetabular components was analyzed, and patient-reported outcome measures (PROMs) obtained. Results. In all, 15 hips were available at ten years. There was no statistically significant difference in PROMS between the two groups; PROMs were improved at ten years compared to preoperative scores. Conventional radiological assessment revealed well-fixed components. There was minimal movement for both porous surfaces in translation (X, Y, Z, 3D translation in mm (median and interquartile range (IQR)), StikTite (Smith and Nephew, Memphis, Tennessee, USA): 0.03 (1.08), 0.12 (0.7), 0.003 (2.3), 0.37 (0.30), and Roughcoat (Smith and Nephew): -0.6 (0.59),–0.1 (0.49), 0.1 (1.12), 0.48 (0.38)), and rotation (X, Y, Z rotation in degrees (median and IQR), (Stiktite: -0.4 (3), 0.28 (2), -0.2 (1), and Roughcoat: - 0.4 (1),–0.1 (1), 0.2 (2)). There was no statistically significant difference between the two cohorts (p-value for X, Y, Z, 3D translation - 0.54, 0.46, 0.87, 0.55 and for X, Y, Z rotation - 0.41, 0.23, 0.23 respectively) at ten years. There was significant correlation between two years and ten years 3D translation for all components (r = 0.81(p =< 0.001)). Conclusion. Both porous ingrowth surfaces demonstrated excellent fixation on plain radiographs and with RSA at ten years. Short-term RSA data are good predictors for long-term migration data


Bone & Joint Research
Vol. 3, Issue 11 | Pages 321 - 327
1 Nov 2014
Palmer AJR Ayyar-Gupta V Dutton SJ Rombach I Cooper CD Pollard TC Hollinghurst D Taylor A Barker KL McNally EG Beard DJ Andrade AJ Carr AJ Glyn-Jones S

Aims. Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head–neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis. . Methods. FAIT is a multicentre superiority parallel two-arm randomised controlled trial comparing physiotherapy and activity modification with arthroscopic surgery for the treatment of symptomatic FAI. Patients aged 18 to 60 with clinical and radiological evidence of FAI are eligible. Principal exclusion criteria include previous surgery to the index hip, established osteoarthritis (Kellgren–Lawrence ≥ 2), hip dysplasia (centre-edge angle < 20°), and completion of a physiotherapy programme targeting FAI within the previous 12 months. Recruitment will take place over 24 months and 120 patients will be randomised in a 1:1 ratio and followed up for three years. The two primary outcome measures are change in hip outcome score eight months post-randomisation (approximately six-months post-intervention initiation) and change in radiographic minimum joint space width 38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Bone Joint Res 2014;3:321–7


Bone & Joint Research
Vol. 2, Issue 2 | Pages 33 - 40
1 Feb 2013
Palmer AJR Thomas GER Pollard TCB Rombach I Taylor A Arden N Beard DJ Andrade AJ Carr AJ Glyn-Jones S

Objectives. The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI. Methods. Surgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31). Results. Clinical equipoise was demonstrated when surgeons were given clinical scenarios and asked whether they would manage a patient operatively or non-operatively. A total of 23 surgeons (77%) who routinely perform FAI surgery were willing to recruit patients into a RCT, and 28 patients (90%) were willing to participate. 75% of responding surgeons believed it was appropriate to randomise patients to non-operative treatment for ≥ 12 months. Conversely, only eight patients (26%) felt this was acceptable, although 29 (94%) were willing to continue non-operative treatment for six months. More patients were concerned about their risk of developing OA than their current symptoms, although most patients felt that the two were of equal importance. Conclusions. We conclude that a RCT comparing operative and non-operative management of FAI is feasible and should be considered a research priority. An important finding for orthopaedic surgical trials is that patients without life-threatening pathology appear willing to trial a treatment for six months without improvement in their symptoms


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 19 - 26
1 Jan 2022
Sevaldsen K Schnell Husby O Lian ØB Farran KM Schnell Husby V

Aims

Highly polished stems with force-closed design have shown satisfactory clinical results despite being related to relatively high early migration. It has been suggested that the minimal thickness of cement mantles surrounding the femoral stem should be 2 mm to 4 mm to avoid aseptic loosening. The line-to-line cementing technique of the femoral stem, designed to achieve stem press-fit, challenges this opinion. We compared the migration of a highly polished stem with force-closed design by standard and line-to-line cementing to investigate whether differences in early migration of the stems occur in a clinical study.

Methods

In this single-blind, randomized controlled, clinical radiostereometric analysis (RSA) study, the migration pattern of the cemented Corail hip stem was compared between line-to-line and standard cementing in 48 arthroplasties. The primary outcome measure was femoral stem migration in terms of rotation and translation around and along with the X-, Y-, and Z- axes measured using model-based RSA at three, 12, and 24 months. A linear mixed-effects model was used for statistical analysis.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1303 - 1310
3 Oct 2020
Kjærgaard K Ding M Jensen C Bragdon C Malchau H Andreasen CM Ovesen O Hofbauer C Overgaard S

Aims

The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).

Methods

Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.


Bone & Joint Open
Vol. 3, Issue 8 | Pages 611 - 617
1 Aug 2022
Frihagen F Comeau-Gauthier M Axelrod D Bzovsky S Poolman R Heels-Ansdell D Bhandari M Sprague S Schemitsch E

Aims. The aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population. Methods. We performed a post hoc exploratory analysis of a fitter cohort of patients from the HEALTH trial. Participants were aged over 50 years and had sustained a low-energy displaced femoral neck fracture (FNF). The fittest participant cohort was defined as participants aged 70 years or younger, classified as American Society of Anesthesiologists grade I or II, independent walkers prior to fracture, and living at home prior to fracture. Multilevel models were used to estimate the effect of THA versus HA on functional outcomes. In addition, a sensitivity analysis of the definition of the fittest participant cohort was performed. Results. There were 143 patients included in the fittest cohort. Mean age was 66 years (SD 4.5) and 103 were female (72%). No clinically relevant differences were found between the treatment groups in the primary and sensitivity analyses. Conclusion. This analysis found no differences in functional outcomes between HA and THA within two years of displaced low-energy FNF in a subgroup analysis of the fittest HEALTH patients. These findings suggest that very few patients above 50 years of age benefit in a clinically meaningful way from a THA versus a HA early after injury. Cite this article: Bone Jt Open 2022;3(8):611–617


Bone & Joint Open
Vol. 5, Issue 2 | Pages 87 - 93
2 Feb 2024
Wolf O Ghukasyan Lakic T Ljungdahl J Sundkvist J Möller M Rogmark C Mukka S Hailer NP

Aims. Our primary aim was to assess reoperation-free survival at one year after the index injury in patients aged ≥ 75 years treated with internal fixation (IF) or arthroplasty for undisplaced femoral neck fractures (uFNFs). Secondary outcomes were reoperations and mortality analyzed separately. Methods. We retrieved data on all patients aged ≥ 75 years with an uFNF registered in the Swedish Fracture Register from 2011 to 2018. The database was linked to the Swedish Arthroplasty Register and the National Patient Register to obtain information on comorbidity, mortality, and reoperations. Our primary outcome, reoperation, or death at one year was analyzed using restricted mean survival time, which gives the mean time to either event for each group separately. Results. Overall, 3,909 patients presenting with uFNFs were included. Of these patients, 3,604 were treated with IF and 305 with primary arthroplasty. There were no relevant differences in age, sex, or comorbidities between groups. In the IF group 58% received cannulated screws and 39% hook pins. In the arthroplasty group 81% were treated with hemiarthroplasty and 19% with total hip arthroplasty. At one year, 32% were dead or had been reoperated in both groups. The reoperation-free survival time over one year of follow-up was 288 days (95% confidence interval (CI) 284 to 292) in the IF group and 279 days (95% CI 264 to 295) in the arthroplasty group, with p = 0.305 for the difference. Mortality was 26% in the IF group and 31% in the arthroplasty group at one year. Reoperation rates were 7.1% in the IF group and 2.3% in the arthroplasty group. Conclusion. In older patients with a uFNF, reoperation-free survival at one year seems similar, regardless of whether IF or arthroplasty is the primary surgery. However, this comparison depends on the choice of follow-up time in that reoperations were more common after IF. In contrast, we found more early deaths after arthroplasty. Our study calls for a randomized trial comparing these two methods. Cite this article: Bone Jt Open 2024;5(2):86–92


Bone & Joint Open
Vol. 4, Issue 5 | Pages 306 - 314
3 May 2023
Rilby K Mohaddes M Kärrholm J

Aims. Although the Fitmore Hip Stem has been on the market for almost 15 years, it is still not well documented in randomized controlled trials. This study compares the Fitmore stem with the CementLeSs (CLS) in several different clinical and radiological aspects. The hypothesis is that there will be no difference in outcome between stems. Methods. In total, 44 patients with bilateral hip osteoarthritis were recruited from the outpatient clinic at a single tertiary orthopaedic centre. The patients were operated with bilateral one-stage total hip arthroplasty. The most painful hip was randomized to either Fitmore or CLS femoral component; the second hip was operated with the femoral component not used on the first side. Patients were evaluated at three and six months and at one, two, and five years postoperatively with patient-reported outcome measures, radiostereometric analysis, dual-energy X-ray absorptiometry, and conventional radiography. A total of 39 patients attended the follow-up visit at two years (primary outcome) and 35 patients at five years. The primary outcome was which hip the patient considered to have the best function at two years. Results. At two and five years, more patients considered the hip with the CLS femoral component as superior but without a statistically significant difference. There were no differences in clinical outcome, magnitude of femoral component migration, or change of bone mineral density at five years. At three months, the Fitmore femoral component had subsided a median -0.71 mm (interquartile range (IQR) -1.67 to -0.20) and the CLS femoral component -0.70 mm (IQR -1.53 to -0.17; p = 0.742). In both groups the femoral head centre had migrated posteriorly (Fitmore -0.17 mm (IQR -0.98 to -0.04) and CLS -0.23 mm (IQR -0.87 to 0.07; p = 0.936)). After three months neither of the femoral components showed much further migration. During the first postoperative year, one Fitmore femoral component was revised due to aseptic loosening. Conclusion. Up to five years, we found no statistically significant difference in outcomes between the Fitmore and the CLS femoral components. The slightly worse outcomes, including one revised hip because of loosening, speaks against the hypothesis that the Fitmore femoral component should be advantageous compared to the CLS if more patients had been recruited to this study. Cite this article: Bone Jt Open 2023;4(5):306–314


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


Bone & Joint Open
Vol. 1, Issue 3 | Pages 13 - 18
1 Mar 2020
Png ME Fernandez MA Achten J Parsons N McGibbon A Gould J Griffin X Costa ML

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. Methods. A within-trial cost-utility analysis (CUA) will be conducted at four months postinjury from a health system (National Health Service and personal social services) perspective. Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months. Sensitivity analysis will be conducted to assess the robustness of the results. Conclusion. The planned analysis strategy described here records our intent to conduct a within-trial CUA alongside the WHiTE5 trial


Bone & Joint Research
Vol. 10, Issue 6 | Pages 354 - 362
1 Jun 2021
Luo Y Zhao X Yang Z Yeersheng R Kang P

Aims. The purpose of this study was to examine the efficacy and safety of carbazochrome sodium sulfonate (CSS) combined with tranexamic acid (TXA) on blood loss and inflammatory responses after primary total hip arthroplasty (THA), and to investigate the influence of different administration methods of CSS on perioperative blood loss during THA. Methods. This study is a randomized controlled trial involving 200 patients undergoing primary unilateral THA. A total of 200 patients treated with intravenous TXA were randomly assigned to group A (combined intravenous and topical CSS), group B (topical CSS), group C (intravenous CSS), or group D (placebo). Results. Mean total blood loss (TBL) in groups A (605.0 ml (SD 235.9)), B (790.9 ml (SD 280.7)), and C (844.8 ml (SD 248.1)) were lower than in group D (1,064.9 ml (SD 318.3), p < 0.001). We also found that compared with group D, biomarker level of inflammation, transfusion rate, pain score, and hip range of motion at discharge in groups A, B, and C were significantly improved. There were no differences among the four groups in terms of intraoperative blood loss (IBL), intramuscular venous thrombosis (IMVT), and length of hospital stay (LOS). Conclusion. The combined application of CSS and TXA is more effective than TXA alone in reducing perioperative blood loss and transfusion rates, inflammatory response, and postoperative hip pain, results in better early hip flexion following THA, and did not increase the associated venous thromboembolism (VTE) events. Intravenous combined with topical injection of CSS was superior to intravenous or topical injection of CSS alone in reducing perioperative blood loss. Cite this article: Bone Joint Res 2021;10(6):354–362


Aims. Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. Methods. We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures. Results. Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar. Conclusion. Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported. Cite this article: Bone Joint J 2021;103-B(2):256–263


Bone & Joint Open
Vol. 1, Issue 9 | Pages 594 - 604
24 Sep 2020
James HK Pattison GTR Griffin J Fisher JD Griffin DR

Aims. To develop a core outcome set of measurements from postoperative radiographs that can be used to assess technical skill in performing dynamic hip screw (DHS) and hemiarthroplasty, and to validate these against Van der Vleuten’s criteria for effective assessment. Methods. A Delphi exercise was undertaken at a regional major trauma centre to identify candidate measurement items. The feasibility of taking these measurements was tested by two of the authors (HKJ, GTRP). Validity and reliability were examined using the radiographs of operations performed by orthopaedic resident participants (n = 28) of a multicentre randomized controlled educational trial (ISRCTN20431944). Trainees were divided into novice and intermediate groups, defined as having performed < ten or ≥ ten cases each for DHS and hemiarthroplasty at baseline. The procedure-based assessment (PBA) global rating score was assumed as the gold standard assessment for the purposes of concurrent validity. Intra- and inter-rater reliability testing were performed on a random subset of 25 cases. Results. In total, 327 DHS and 248 hemiarthroplasty procedures were performed by 28 postgraduate year (PGY) 3 to 5 orthopaedic trainees during the 2014 to 2015 surgical training year at nine NHS hospitals in the West Midlands, UK. Overall, 109 PBAs were completed for DHS and 80 for hemiarthroplasty. Expert consensus identified four ‘final product analysis’ (FPA) radiological parameters of technical success for DHS: tip-apex distance (TAD); lag screw position in the femoral head; flushness of the plate against the lateral femoral cortex; and eight-cortex hold of the plate screws. Three parameters were identified for hemiarthroplasty: leg length discrepancy; femoral stem alignment; and femoral offset. Face validity, content validity, and feasibility were excellent. For all measurements, performance was better in the intermediate compared with the novice group, and this was statistically significant for TAD (p < 0.001) and femoral stem alignment (p = 0.023). Concurrent validity was poor when measured against global PBA score. This may be explained by the fact that they are measuring difference facets of competence. Intra-and inter-rater reliability were excellent for TAD, moderate for lag screw position (DHS), and moderate for leg length discrepancy (hemiarthroplasty). Use of a large multicentre dataset suggests good generalizability of the results to other settings. Assessment using FPA was time- and cost-effective compared with PBA. Conclusion. Final product analysis using post-implantation radiographs to measure technical skill in hip fracture surgery is feasible, valid, reliable, and cost-effective. It can complement traditional workplace-based assessment for measuring performance in the real-world operating room . It may have particular utility in competency-based training frameworks and for assessing skill transfer from the simulated to live operating theatre. Cite this article: Bone Joint Open 2020;1-9:594–604


Bone & Joint Open
Vol. 4, Issue 5 | Pages 385 - 392
24 May 2023
Turgeon TR Hedden DR Bohm ER Burnell CD

Aims

Instability is a common cause of failure after total hip arthroplasty. A novel reverse total hip has been developed, with a femoral cup and acetabular ball, creating enhanced mechanical stability. The purpose of this study was to assess the implant fixation using radiostereometric analysis (RSA), and the clinical safety and efficacy of this novel design.

Methods

Patients with end-stage osteoarthritis were enrolled in a prospective cohort at a single centre. The cohort consisted of 11 females and 11 males with mean age of 70.6 years (SD 3.5) and BMI of 31.0 kg/m2 (SD 5.7). Implant fixation was evaluated using RSA as well as Western Ontario and McMaster Universities Osteoarthritis Index, Harris Hip Score, Oxford Hip Score, Hip disability and Osteoarthritis Outcome Score, 38-item Short Form survey, and EuroQol five-dimension health questionnaire scores at two-year follow-up. At least one acetabular screw was used in all cases. RSA markers were inserted into the innominate bone and proximal femur with imaging at six weeks (baseline) and six, 12, and 24 months. Independent-samples t-tests were used to compare to published thresholds.