Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021). Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings. The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training. We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.
In this RCT the primary aim was to assess whether a short (125mm) Exeter V40 stem offered an equivalent hip specific function compared to the standard (150mm) stem when used for cemented total hip arthroplasty (THA). Secondary aims were to evaluate health-related quality of life (HRQoL), patient satisfaction, stem height and alignment, radiographic loosening, and complications between the two stems. A prospective multicentre double-blind randomised control trial was conducted. During a 15-month period, 220 patients undergoing THA were randomised to either a standard (n=110) or short (n=110) stem Exeter. There were no significant (p≥0.065) differences in preoperative variables between the groups. Functional outcomes and radiographic assessment were undertaken at 1- and 2-years. There were no differences (p=0.428) in hip specific function according to the Oxford hip score at 1-year (primary endpoint) or at 2-years (p=0.767) between the groups. The short stem group had greater varus angulation (0.9 degrees, p=0.003) when compared to the standard group and were more likely (odds ratio 2.42, p=0.002) to have varus stem alignment beyond one standard deviation from the mean. There were no significant (p≥0.083) differences in the Forgotten joint scores, EuroQol-5-Dimension, EuroQol-VAS, Short form 12, patient satisfaction, complications, stem height or radiolucent zones at 1 or 2-years between the groups. The Exeter short stem offers equivalent hip specific function, HRQoL, patient satisfaction, and limb length when compared to the standard stem at 2-years post-operation. However, the short stem was associated with a greater rate of varus malalignment which may influence future implant survival.
Controversy persists over whether cemented or uncemented fixation is more effective in reducing revision and mortality risks following primary total hip arthroplasty (THA). Despite a shift towards uncemented THA in Europe, Australia, and the US, no consensus exists on superior outcomes. This ambiguity in evidence from randomized controlled trials (RCTs) and observational studies necessitates advanced research methodologies to derive more definitive conclusions. This study investigates the causal impact of THA fixation type on 2-year and 5-year revision rates, along with 90-day mortality, utilizing a regression discontinuity (RD) design in scenarios where fixation choice is guided by patient age. Employing data from the Dutch Arthroplasty Register, we conducted a cohort study on primary THAs for osteoarthritis from 2007 to 2019. A “fuzzy” RD design was executed to compute the Local Average Treatment Effect for subjects around the age-based selection threshold for fixation type. The main outcome of interest was the revision rate at 2 years post-operation. Analysis for the 2-year revision endpoint, covering any cause, included 2,344 females and 1,671 males across 5 hospitals each, with no significant variation in revision rates observed. For the 5-year mark, 1,058 females in 3 hospitals and 214 males in 1 hospital were examined, similarly showing no significant differences. Mortality within 90 days post-operation was also investigated in 5 female and 7 male cohorts, with 2,180 and 2,145 surgeries respectively, yielding no substantial disparities. In conclusion, the RD analysis revealed no notable differences in revision rates at 2 and 5 years or in early mortality based on the fixation method used in THA. These outcomes suggest that the age-based preference for THA fixation may not influence the revision or mortality risk, underscoring the value of RD design in deriving causal insights from observational data.
Occlusion of the femoral canal is an important step in cemented hip arthroplasty. The goal of occlusion is to allow cement pressurisation and prevent cement egress into the femoral diaphysis. There are numerous designs of cement plugs made out of different materials but there is no consensus or clinical guideline for the choice of cement restrictors. At our centre two types of plugs are used – autologous bone block from femoral canal and the gelatine C-plug (Depuy International). We conducted this study to evaluate the stability of these two plugs and their effect on quality of cementation. The purpose of our study was to assess retrospectively both the length of the “cement tail” i.e. the length of the cement column distal to the stem tip and the cement mantle quality in both groups. A retrospective comparative review was designed after approval from the local R & D department. Power analysis indicated that a minimum of 74 patients per group would be needed. A total of 203 consecutive patients were analysed, 89 received an autologous bone block and 114 had C-plugs. Apart from the plugs both the groups were treated similarly with regards to surgical approach, cementing and operative technique. Surgical technique was to achieve adequate pressurisation and a minimum length of cement tail. Immediate post-operative radiographs were used for analysis. The primary outcome measure was the length of the cement tail, i.e. the length of the cement column from the tip of the stem. The secondary outcome measure was the quality of cementing which was quantified using Barrack's grading. The data was tested for normality using the Shapiro-Wilk test. The means of cement tail lengths in between the two groups were compared using the Wilcoxon ranked sum test. The cementation grades were compared using ANOVA. The correlation between the length of cement tail and the quality of cementation was calculated using ordinal regression. Both the groups were similar in terms of age, sex and primary diagnosis. The mean cement tail length was 6.42 (SE 0.71 mms; range-0–31) in the bone block group and 17.11 (SE-1.34 mms; range 0–65.7 mms) in the C-plug group. This difference was statistically significant (p< 0.0001). The proportion of patients with good quality of cementation (grade A) was significantly higher in the bone block group (80.6%) as compared to the C-plug group (56%) (p < 0.0001). There was a negative correlation between the length of the cement tail and the Barrack grade (rho=0.398), indicating that a short cement tail is associated with better quality cementation. Quality of cementation is of paramount importance in cemented hip arthroplasty. Revision surgery can be more difficult and higher risk in the presence of a long cement tail. We have shown that better quality cementation and shorter cement tails can be achieved with the cheapest of all options for canal occlusion, an autologous bone block and recommend its use.
Although the technique of autogenous acetabular bone grafting has been widely used to augment containment of the acetabulum in total hip arthroplasty (THA) for developmental dysplasia, the role of this technique in improving long-term results remains controversial. We present the long-term results of cemented THA with acetabular bone grafting in 112 patients (133 hips) in order to clarify the factors which affect the outcome. The mean follow-up was for 12.3 years (8 to 24). Kaplan-Meier survivorship analysis predicted a rate of survival of the acetabular component at 15 years of 96% (95% confidence interval (CI) 92 to 99) with revision for aseptic loosening as the endpoint, and of 75% (95% CI 65 to 85) when radiological loosening was used. Parametric survivorship analysis using the Cox proportional-hazards model indicated that trochanteric nonunion, lateral placement of the socket, and delayed trabecular reorientation of the bone graft were risk factors for loosening of the acetabular component. Our findings have shown that autologous acetabular bone grafting is of value for long-term success provided that the risk factors are reduced.
Three radiological methods are commonly used to assess the outcome of total hip replacement (THR). They aim to record the appearance of lucent areas and migration of the prosthesis in a reproducible manner. Two of them were designed to monitor the implant through time and one to grade the quality of cementing. We have measured the level of inter- and intraobserver agreement in all three systems. We randomised 30 patients to receive either finger packing or retrograde gun cementing during Charnley hip replacements. The postoperative departmental radiographs were evaluated in a blinded study by two orthopaedic trainees, two consultants and two experts in THR. The trainees and consultants repeated the exercise at least two weeks later. We used the unweighted kappa statistic to establish the levels of agreement. In general, intraobserver agreement was moderate but interobserver agreement was poor, with levels similar to or less than those expected by chance. Our results indicate that such systems cannot provide reliable data from centres in different parts of the world, with various levels of surgeon evaluating radiographs at differing time intervals. We discuss the problem and suggest some methods of improvement.
We carried out primary cemented total hip arthroplasty (THA) on 25 hips in 21 patients with developmental dysplasia of the hip, using autogenous acetabular bone grafts. The socket was placed at the level of the true acetabulum and bone from the femoral neck was used as graft. Five hips were excluded, leaving 20 which were followed up for a mean of 12.9 years (10 to 18). The mean modified Merle d’Aubigné and Postel functional scores were 5.6 for pain, 4.3 for mobility and 4.2 for range of movement. Radiological examination showed aseptic loosening in three sockets but not in the stems. The bone grafts had united and showed no evidence of late failure.
We have analysed from the Finnish Arthroplasty Register the long-term survivorship of the 12 most commonly-used cemented implants between 1980 and 2005 in patients aged 55 years or older with osteoarthritis. Only two designs of femoral component, the Exeter Universal and the Müller Straight femoral component had a survivorship of over 95% at ten years with revision for aseptic loosening as the endpoint. At 15 years of the femoral and acetabular component combinations, only the Exeter Universal/Exeter All-poly implant had a survival rate of over 90% with revision for aseptic loosening as the endpoint. In the subgroup of patients aged between 55 and 64 years, survivorship overall was less than 90% at ten years. The variation in the long-term rates of survival of different cemented hip implants was considerable in patients aged 55 years or older. In those aged between 55 and 64 years, none of the cemented prostheses studied yielded excellent long-term survival rates (≥ 90% at 15 years).
We report the five-year outcome of a randomised
controlled trial which used radiostereometric analysis (RSA) to assess
the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene
wear A total of 120 patients, 85 women and 35 men with a mean age
of 70 years (59 to 80) who were scheduled for primary cemented total
hip arthroplasty were randomly allocated to four study groups. Patients
were blinded to their group assignment and received either a conventional
polyethylene (CPE) or a highly cross-linked (HXL) acetabular component
of identical design. On the femoral side patients received a 28
mm head made of either cobalt-chromium (CoCr) or OxZr. The proximal head penetration (wear) was measured with repeated
RSA examinations over five years. Clinical outcome was measured
using the Harris hip score. There was no difference in polyethylene wear between the two
head materials when used with either of the two types of acetabular
component (p = 0.3 to 0.6). When comparing the two types of polyethylene
there was a significant difference in favour of HXLPE, regardless
of the head material used (p <
0.001). In conclusion, we found no advantage of OxZr over CoCr in terms
of polyethylene wear after five years of follow-up. Our findings
do not support laboratory results which have shown a reduced rate
of wear with OxZr. They do however add to the evidence on the better
resistance to wear of HXLPE over CPE. Cite this article:
Objectives. Our primary aim was to describe migration of the Exeter stem with a 32 mm head on highly crosslinked polyethylene and whether this is influenced by age. Our secondary aims were to assess functional outcome, satisfaction, activity, and bone mineral density (BMD) according to age. Patients and Methods. A prospective cohort study was conducted. Patients were recruited into three age groups: less than 65 years (n = 65), 65 to 74 years (n = 68), and 75 years and older (n = 67). There were 200 patients enrolled in the study, of whom 115 were female and 85 were male, with a mean age of 69.9 years (sd 9.5, 42 to 92). They were assessed preoperatively, and at three, 12 and, 24 months postoperatively. Stem migration was assessed using Einzel-Bild-Röntgen-Analyse (EBRA). Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), EuroQol-5 domains questionnaire (EQ-5D), short form-36 questionnaire (SF-36,) and patient satisfaction were used to assess outcome. The Lower Extremity Activity Scale (LEAS), Timed Up and Go (TUG) test, and activPAL monitor (energy expelled, time lying/standing/walking and step count) were used to assess activity. The BMD was assessed in Gruen and Charnley zones. Results. Mean varus/valgus tilt was -0.77⁰ and axial subsidence was -1.20 mm. No significant difference was observed between age groups (p ⩾ 0.07). There was no difference according to age group for postoperative WOMAC (p ⩾ 0.11), HHS (p ⩾ 0.06), HOOS (p ⩾ 0.46), EQ-5D (p ⩾ 0.38), patient satisfaction (p ⩾ 0.05), or activPAL (p ⩾ 0.06). Patients 75 years and older had a worse SF-36 physical function (p = 0.01) and physical role (p = 0.03), LEAS score (p < 0.001), a shorter TUG (p = 0.01), and a lower BMD in Charnley zone 1 (p = 0.02). Conclusion. Exeter stem migration is within normal limits and is not influenced by age group. Functional outcome, patient satisfaction, activity level, and periprosthetic BMD are similar across all age groups. Cite this article: N. D. Clement, M. Bardgett, K. Merrie, S. Furtado, R. Bowman, D. J. Langton, D. J. Deehan, J. Holland.
This study reports the results of 38 total hip arthroplasties (THAs) in 33 patients aged less than 50 years, using the JRI Furlong hydroxyapatite ceramic (HAC)-coated femoral component. We describe the survival, radiological, and functional outcomes of 33 patients (38 THAs) at a mean follow-up of 27 years (25 to 32) between 1988 and 2018.Aims
Methods
The aim of this study was to compare open reduction and internal fixation (ORIF) with revision surgery for the surgical management of Unified Classification System (UCS) type B periprosthetic femoral fractures around cemented polished taper-slip femoral components following primary total hip arthroplasty (THA). Data were collected for patients admitted to five UK centres. The primary outcome measure was the two-year reoperation rate. Secondary outcomes were time to surgery, transfusion requirements, critical care requirements, length of stay, two-year local complication rates, six-month systemic complication rates, and mortality rates. Comparisons were made by the form of treatment (ORIF vs revision) and UCS type (B1 vs B2/B3). Kaplan-Meier survival analysis was performed with two-year reoperation for any reason as the endpoint.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
This study reports the results of 38 total hip
arthroplasties (THAs) in 33 patients aged <
50 years, using the
JRI Furlong hydroxyapatite ceramic (HAC)-coated femoral component.
This represents an update of previous reports of the same cohort
at ten and 16 years, which were reported in 2004 and 2009, respectively.
We describe the survival, radiological and functional outcomes at
a mean follow-up of 21 years (17 to 25). Of the surviving 34 THAs,
one underwent femoral revision for peri-prosthetic fracture after
21 years, and one patient (one hip) was lost to follow-up. Using
aseptic loosening as the end-point, 12 hips (31.5%) needed acetabular
revision but none needed femoral revision, demonstrating 100% survival
(95% confidence interval 89 to 100). In young patients with high demands, the Furlong HAC–coated femoral
component gives excellent long-term results. Cite this article: