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
Aims. The purpose of this study is to evaluate early outcomes with the use of a smartphone-based exercise and educational care management system after total hip arthroplasty (THA) and demonstrate decreased use of in-person physiotherapy (PT). Methods. A multicentre, prospective randomized controlled trial was conducted to evaluate a smartphone-based care platform for primary THA. Patients randomized to the control group (198) received the institution’s
Aims. Delirium is associated with adverse outcomes following hip fracture, but the prevalence and significance of delirium for the prognosis and ongoing rehabilitation needs of patients admitted from home is less well studied. Here, we analyzed relationships between delirium in patients admitted from home with 1) mortality; 2) total length of hospital stay; 3) need for post-acute inpatient rehabilitation; and 4) hospital readmission within 180 days. Methods. This observational study used routine clinical data in a consecutive sample of hip fracture patients aged ≥ 50 years admitted to a single large trauma centre during the COVID-19 pandemic between 1 March 2020 and 30 November 2021. Delirium was prospectively assessed as part of routine care by the 4 A’s Test (4AT), with most assessments performed in the emergency department. Associations were determined using logistic regression adjusted for age, sex, Scottish Index of Multiple Deprivation quintile, COVID-19 infection within 30 days, and American Society of Anesthesiologists grade. Results. A total of 1,821 patients were admitted, with 1,383 (mean age 79.5 years; 72.1% female) directly from home. Overall, 87 patients (4.8%) were excluded due to missing 4AT scores. Delirium prevalence in the whole cohort was 26.5% (460/1,734): 14.1% (189/1,340) in the subgroup of patients admitted from home, and 68.8% (271/394) in the remaining patients (comprising care home residents and inpatients when fracture occurred). In patients admitted from home, delirium was associated with a 20-day longer total length of stay (p < 0.001). In multivariable analyses, delirium was associated with higher mortality at 180 days (odds ratio (OR) 1.69 (95% confidence interval (CI) 1.13 to 2.54); p = 0.013), requirement for post-acute inpatient rehabilitation (OR 2.80 (95% CI 1.97 to 3.96); p < 0.001), and readmission to hospital within 180 days (OR 1.79 (95% CI 1.02 to 3.15); p = 0.041). Conclusion. Delirium affects one in seven patients with a hip fracture admitted directly from home, and is associated with adverse outcomes in these patients. Delirium assessment and effective management should be a mandatory part of
The Birmingham Hip Resurfacing (BHR) arthroplasty has been used as a surgical treatment of coxarthrosis since 1997. We present 20-year results of 234 consecutive BHRs performed in our unit. Between 1999 and 2001, there were 217 patients: 142 males (65.4%), mean age 52 years (18 to 68) who had 234 implants (17 bilateral). They had patient-reported outcome measures collected, imaging (radiograph and ultrasound), and serum metal ion assessment. Survivorship analysis was performed using Kaplan-Meier estimates. Revision for any cause was considered as an endpoint for the analysis.Aims
Methods
The aims of this study were to determine if an increasing serum cobalt (Co) and/or chromium (Cr) concentration is correlated with a decreasing Harris Hip Score (HHS) and Hip disability and Osteoarthritis Outcome Score (HOOS) in patients who received the Articular Surface Replacement (ASR) hip resurfacing arthroplasty (HRA), and to evaluate the ten-year revision rate and show if sex, inclination angle, and Co level influenced the revision rate. A total of 62 patients with an ASR-HRA were included and monitored yearly postoperatively. At follow-up, serum Co and Cr levels were measured and the HHS and the HOOS were scored. In addition, preoperative patient and implant variables and the need for revision surgery were recorded. We used a linear mixed model to relate the serum Co and Cr levels to different patient-reported outcome measures (PROMs). For the survival analyses we used the Kaplan-Meier and Cox regression model.Aims
Methods
The primary aim of this study is to compare mobility status of patients receiving oral oxycodone with those receiving subcutaneous alfentanil as analgesic methods prior to mobilization to help physiotherapy compliance after hip fracture surgery. The secondary aims are to assess postoperative pain, health-related quality of life, in-hospital length of stay, total use of analgesia over postoperative days 1 and 2 (POD 1 and POD 2), complication rates within 30 days, and 30-day mortality rates. A single-centre, prospective cohort study of 64 patients will be undertaken. Patients undergoing surgery for femoral neck fractures at the study centre will be recruited. Patients with a hip fracture meeting the inclusion/exclusion criteria will be enrolled on admission. Patients who have been administered oral oxycodone will be compared to those prescribed alfentanil for pain prior to mobilization with physiotherapists on POD 1 and POD 2. Which drug a patient receives is reliant of the prescriptions given by the medical team, and in current practice this varies at approximately 50:50. Mobilization will be defined as the ability to stand on and weightbear both feet with or without assistance.Aims
Methods
The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total hip arthroplasty (THA). The patient-acceptable symptom state (PASS) is the minimum cut-off value that corresponds to a patient’s satisfactory state-of-health. Despite the validity and reliability of the FJS-12 having been previously demonstrated, the PASS has yet to be clearly defined. This study aims to define the PASS of the FJS-12 following primary THA. We retrospectively reviewed all patients who underwent primary elective THA from 2019 to 2020, and answered both the FJS-12 and the Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) questionnaires one-year postoperatively. HOOS, JR score was used as the anchor to estimate the PASS of FJS-12. Two statistical methods were employed: the receiver operating characteristic (ROC) curve point, which maximized the Youden index; and 75th percentile of the cumulative percentage curve of patients who had the HOOS, JR score difference larger than the cut-off value.Aims
Methods
In Africa the amount of joint replacement surgery is increasing, but the indications for operation and the age of the patients are considerably different from those in the developed world. New centres with variable
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. 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.Aims
Methods
Bone marrow-derived mesenchymal stem cells obtained from bone marrow aspirate concentrate (BMAC) with platelet-rich plasma (PRP), has been used as an adjuvant to hip decompression. Early results have shown promise for hip preservation in patients with osteonecrosis (ON) of the femoral head. The purpose of the current study is to examine the mid-term outcome of this treatment in patients with precollapse corticosteroid-induced ON of the femoral head. In all, 22 patients (35 hips; 11 males and 11 females) with precollapse corticosteroid-induced ON of the femoral head underwent hip decompression combined with BMAC and PRP. Mean age and BMI were 43 years (SD 12) and 31 kg/m² (SD 6), respectively, at the time of surgery. Survivorship free from femoral head collapse and total hip arthroplasty (THA) and risk factors for progression were evaluated at minimum five-years of clinical follow-up with a mean follow-up of seven years (5 to 8).Aims
Methods
The aims of this study were to develop an in vivo model of periprosthetic joint infection (PJI) in cemented hip hemiarthroplasty, and to monitor infection and biofilm formation in real-time. Sprague-Dawley rats underwent cemented hip hemiarthroplasty via the posterior approach with pre- and postoperative gait assessments. Infection with Aims
Methods
This study evaluates risk factors influencing fracture characteristics for postoperative periprosthetic femoral fractures (PFFs) around cemented stems in total hip arthroplasty. Data were collected for PFF patients admitted to eight UK centres between 25 May 2006 and 1 March 2020. Radiographs were assessed for Unified Classification System (UCS) grade and AO/OTA type. Statistical comparisons investigated relationships by age, gender, and stem fixation philosophy (polished taper-slip (PTS) vs composite beam (CB)). The effect of multiple variables was estimated using multinomial logistic regression to estimate odds ratios (ORs) with 95% confidence intervals (CIs). Surgical treatment (revision vs fixation) was compared by UCS grade and AO/OTA type.Aims
Methods
There is a paucity of long-term studies analyzing risk factors for failure after single-stage revision for periprosthetic joint infection (PJI) following total hip arthroplasty (THA). We report the mid- to long-term septic and non-septic failure rate of single-stage revision for PJI after THA. We retrospectively reviewed 88 cases which met the Musculoskeletal Infection Society (MSIS) criteria for PJI. Mean follow-up was seven years (1 to 14). Septic failure was diagnosed with a Delphi-based consensus definition. Any reoperation for mechanical causes in the absence of evidence of infection was considered as non-septic failure. A competing risk regression model was used to evaluate factors associated with septic and non-septic failures. A Kaplan-Meier estimate was used to analyze mortality.Aims
Methods
We aimed to compare the implant survival, complications, readmissions, and mortality of Vancouver B2 periprosthetic femoral fractures (PFFs) treated with internal fixation with that of B1 PFFs treated with internal fixation and B2 fractures treated with revision arthroplasty. We retrospectively reviewed the data of 112 PFFs, of which 47 (42%) B1 and 27 (24%) B2 PFFs were treated with internal fixation, whereas 38 (34%) B2 fractures underwent revision arthroplasty. Decision to perform internal fixation for B2 PFFs was based on specific radiological (polished femoral components, intact bone-cement interface) and clinical criteria (low-demand patient). Median follow-up was 36.4 months (24 to 60). Implant survival and mortality over time were estimated with the Kaplan-Meier method. Adverse events (measured with a modified Dindo-Clavien classification) and 90-day readmissions were additionally compared between groups.Aims
Methods
The aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients. This was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the “Best Practice Tariff” indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients.Aims
Methods
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. 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.Aims
Methods
The primary aim of this study was to compare the hip-specific functional outcome of robotic assisted total hip arthroplasty (rTHA) with manual total hip arthroplasty (mTHA) in patients with osteoarthritis (OA). Secondary aims were to compare general health improvement, patient satisfaction, and radiological component position and restoration of leg length between rTHA and mTHA. A total of 40 patients undergoing rTHA were propensity score matched to 80 patients undergoing mTHA for OA. Patients were matched for age, sex, and preoperative function. The Oxford Hip Score (OHS), Forgotten Joint Score (FJS), and EuroQol five-dimension questionnaire (EQ-5D) were collected pre- and postoperatively (mean 10 months (SD 2.2) in rTHA group and 12 months (SD 0.3) in mTHA group). In addition, patient satisfaction was collected postoperatively. Component accuracy was assessed using Lewinnek and Callanan safe zones, and restoration of leg length were assessed radiologically.Aims
Methods
Tranexamic acid (TXA) has been shown to reduce blood loss and transfusion requirements in patients undergoing orthopaedic surgery. There remains a lack of prospective evidence for the use of TXA in patients undergoing periacetabular osteotomy (PAO). The purpose of this study was to determine if intravenous (IV) TXA is effective in reducing calculated blood loss and transfusions after PAO. This was a single-centre prospective double-blind placebo-controlled randomized trial of 81 patients aged 12 to 45 years undergoing elective PAO by a single surgeon. The intervention group (n = 40) received two doses of IV TXA of a maximum 1 g in each dose; the control group (n = 41) received two doses of 50 ml 0.9% saline IV. The primary outcome was perioperative calculated blood loss. Secondary outcomes included allogenic transfusions and six-week postoperative complications.Aims
Methods
To assess the variation in pre-fracture quality of life (QoL) within the UK hip fracture population, and quantify the nature and strength of associations between QoL and other routinely collected patient characteristics and treatment choices. The World Hip Trauma Evaluation (WHiTE) study, an observational cohort study of UK hip fracture patients, collects a range of routine data and a health-related QoL score (EuroQol five-dimension questionnaire (EQ-5D)). Pre-fracture QoL data are summarized and statistical models fitted to understand associations between QoL, patient characteristics, fracture types, and operations.Aims
Methods
Although good clinical outcomes have been reported for monolithic tapered, fluted, titanium stems (TFTS), early results showed high rates of subsidence. Advances in stem design may mitigate these concerns. This study reports on the use of a current monolithic TFTS for a variety of indications. A multi-institutional retrospective study of all consecutive total hip arthroplasty (THA) and revision total hip arthroplasty (rTHA) patients who received the monolithic TFTS was conducted. Surgery was performed by eight fellowship-trained arthroplasty surgeons at four institutions. A total of 157 hips in 153 patients at a mean follow-up of 11.6 months (SD7.8) were included. Mean patient age at the time of surgery was 67.4 years (SD 13.3) and mean body mass index (BMI) was 28.9 kg/m2 (SD 6.5). Outcomes included intraoperative complications, one-year all-cause re-revisions, and subsidence at postoperative time intervals (two weeks, six weeks, six months, nine months, and one year).Aims
Methods
The purpose of this study was to examine whether leg-length discrepancy (LLD) following unilateral total hip arthroplasty (THA) affects the incidence of contralateral head collapse and subsequent THA in patients with bilateral osteonecrosis, and to determine factors associated with subsequent collapse. We identified 121 patients with bilateral non-traumatic osteonecrosis who underwent THA between 2003 and 2011 to treat a symptomatic hip, and who also exhibited medium-to-large lesions (necrotic area ≥ 30%) in an otherwise asymptomatic non-operated hip. Of the 121 patients, 71 were male (59%) and 50 were female (41%), with a mean age of 51 years (19 to 71) at the time of initial THA. All patients were followed for at least five years and were assessed according to the presence of a LLD (non-LLD Aims
Patients and Methods
The routine use of dual-mobility (DM) acetabular components in total hip arthroplasty (THA) may not be cost-effective, but an increasing number of patients undergoing THA have a coexisting spinal disorder, which increases the risk of postoperative instability, and these patients may benefit from DM articulations. This study seeks to examine the cost-effectiveness of DM components as an alternative to standard articulations in these patients. A decision analysis model was used to evaluate the cost-effectiveness of using DM components in patients who would be at high risk for dislocation within one year of THA. Direct and indirect costs of dislocation, incremental costs of using DM components, quality-adjusted life-year (QALY) values, and the probabilities of dislocation were derived from published data. The incremental cost-effectiveness ratio (ICER) was established with a willingness-to-pay threshold of $100 000/QALY. Sensitivity analysis was used to examine the impact of variation.Aims
Patients and Methods
The purpose of this study was to determine the lifetime risk
of revision surgery for patients undergoing Charnley cemented total
hip arthroplasty (THA), with 40-year follow up, using death as a
competing risk. We retrospectively reviewed 2000 cemented Charnley THAs, with
51 living hips available at 40 years. Aims
Materials and Methods
We report a retrospective review of the incidence of venous thromboembolism in 463 consecutive patients who underwent primary total hip arthroplasty (487 procedures). Treatment included both total hip replacement and hip resurfacing, and the patients were managed without anticoagulants. The thromboprophylaxis regimen included an antiplatelet agent, generally aspirin, hypotensive epidural anaesthesia, elastic compression stockings and early mobilisation. In 258 of these procedures (244 patients) performed in 2005 (cohort A) mechanical compression devices were not used, whereas in 229 (219 patients) performed during 2006 (cohort B) bilateral intermittent pneumatic calf compression was used. All operations were performed through a posterior mini-incision approach. Patients who required anticoagulation for pre-existing medical problems and those undergoing revision arthroplasty were excluded. Doppler ultrasonographic screening for deep-vein thrombosis was performed in all patients between the fourth and sixth post-operative days. All patients were reviewed at a follow-up clinic six to ten weeks after the operation. In addition, reponse to a questionnaire was obtained at the end of 12 weeks post-operatively. No symptomatic calf or above-knee deep-vein thrombosis or pulmonary embolism occurred. In 25 patients in cohort A (10.2%) and in ten patients in cohort B (4.6%) asymptomatic calf deep-vein thromboses were detected ultrasonographically. This difference was statistically significant (p = 0.03). The regimen followed by cohort B offers the prospect of a low incidence of venous thromboembolism without subjecting patients to the higher risk of bleeding associated with anticoagulant use.
