Abstract.
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 Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic.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.
It is generally accepted that the cement mantle surrounding the femoral component of a cemented total hip arthroplasty (THA) should be complete without any defects, and of at least 2 mm in thickness. Radiographic evaluation is the basis for assessment of the cement mantle. The adequacy of radiographic interpretation is subject to debate. Poor interobserver and intraobserver reproducibility of radiographic cement mantle assessment has been reported. In this study, 3D template software was used that allow anatomical measurements and analysis of three-dimensional digital femura geometry based on CT scans. The purpose of this study is to analyze the three-dimensional cement mantle thickness of cemented hip stem. 52 hips that underwent THA with Exeter stem (Stryker Orthopaedics, Mahwah, NJ) were enrolled in this study. All surgeries were performed by a single surgeon. There were 49 hips in 49 women and 3 hips in 3 men. The average age at surgery was 73 years (range, 60–88 years). The etiology of the hip lesions were osteoarthrosis in 49, rheumatoid arthritis in 3, and osteonecrosis of the femoral head in 1. For preoperative and postoperative evaluation, a CT scan of the pelvis and knee joint was obtained and was transferred to 3D template software (Zed hip, Lexi, Tokyo, Japan). We evaluated the alignment for stem anteversion/valgus/anterior tilt angles and the contact of the cortical bone with the cement mantle was evaluated.Purpose
Materials and Methods
The aim of this study was to (I) determine the intra-operative temperature of the femoral cancellous bed prior to insertion of prosthesis, (II) to investigate whether the magnitude of the temperature gradient effects interface porosity (III) to develop clinically relevant recommendations.
The cement mantle was sectioned transversely, then longitudinally to expose the cement-prosthesis interface. This was stained with acrylic dye to facilitate image analysis. Three mantles for each temperature were produced.
In relation to the conduct of this study, one or more of the authors is in receipt of a research grant from a non-commercial source.
Successful total hip arthroplasty (THA) in the presence of developmental dysplasia of the hip (DDH) depends on restoration of the anatomic centre of hip rotation and may require simultaneous femoral osteotomy. Techniques using uncemented components are widely reported. In osteopenic bone an all-cemented technique may be more appropriate; however, the outcome following this procedure is not known. We present the results of a series of thirty-five cemented THA with simultaneous subtrochanteric osteotomy. 28 patients with DDH (35 hips) who underwent this procedure at a mean age of 47.3 years were retrospectively reviewed. Two patients (two hips) died within 12 months of surgery. The clinical notes and radiographs of the remaining patients were reviewed with a minimum follow-up of 2 years (mean, 5.6 years; range, 2-14 years). Complications were noted. SF-12 and Oxford hip scores (OHS) were recorded for 18 patients pre-operatively and after 6 and 12 months.Hypothesis
Methods and analysis
We have investigated the long-term (minimum follow-up period; 10 years) clinical results of the total hip arthroplasty (THA) using K-MAX HS-3 tapered stem. In K-MAX HS-3 THA (Kyocera Medical, Kyoto, Japan), cemented titanium alloy stem and all polyethylene cemented socket are used. This stem has the double tapered symmetrical stem design, allowing the rotational stability and uniform stress distribution. The features of this stem are; 1. Vanadium-free high-strength titanium alloy (Ti-15Mo-5Zr-3Al), 2. Double-tapered design, 3. Smooth surface (Ra 0.4µm), 4. Broad proximal profile, 5. Small collar. Previous type stem, which was made of the same smooth-surface titanium alloy, has the design with cylindrical stem tip, allowing the maximum filling of the femoral canal. Osteolysis at the distal end of the stem had been reported in a few cases in previous type with cylindrical stem tip, probably due to the local stress concentration. Therefore the tapered stem was designed, expecting better clinical results. 157 THAs using HS-3 taper type stem were performed at Kitano Hospital between March 2004 and March 2008. And 101 THAs, followed for more than 10 years, were investigated (follow-up rate; 64.3%). The average age of the patients followed at the operation was 61.7 years and the average follow-up period was 10.9 years. The all-polyethylene socket was fixed by bone cement, and the femoral head material was CoCr (22mm; 5 hips, 26 mm; 96 hips).Introduction
Materials and Methods
British Orthopaedic Association (BOA) Guidelines recommend clinical and radiological follow-up after Total Hip Arthroplasty (THA) at 1 year, 5 years and every 5 years thereafter to detect asymptomatic failure. To evaluate the importance of routine follow-up appointments (OPAs) in detecting failing implants the presentation of patients undergoing revision THA was reviewed. 176 patients who received 183 first-time revision THAs over a seven-year period (2003-2010) were identified from an arthroplasty database. A preliminary study sampled 46 THAs in 45 patients. Retrospective chart review recorded symptoms and mode of presentation. Follow-up OPA costs were calculated to estimate savings. All patients had symptoms at the time of revision (pain 96%, decreased mobility 76%, limp 35%, stiffness 26%, night pain 24%). Route of presentation was 80% new referrals (GP 63%, in-patient 9%, A&E 4%, Rheumatology 4%) vs 20% routine orthopaedic follow-up. The minimum cost for a routine follow-up OPA was £35. Assuming discharge after the earliest review when the patient has returned to full normal activities the estimated saving for the 2009 cohort of 377 primary THAs performed in our hospital is £13195 at 1 year and £52780 over the lifespan of the implants (assuming average 15 year survival). Following uncomplicated primary cemented THA in our hospital asymptomatic implant failure is unlikely. Symptomatic patients tend to present mainly to their GP and other specialities, rather than orthopaedic follow-up OPAs. Early discharge after return to full normal activities would be safe and lead to significant financial savings.
The global rapid growth of the aging population has some likelihood to create a serious crisis on health-care and economy at an unprecedented pace. To extend Healthy Life Expectancy (HALE) in a number of countries, it is desired more than ever to investigate characteristic and prognosis of numerous diseases. This enlightenment and recent studies on patient-reported outcome measures (PROMs) will drive the increasing interest in the quality of life among the world. The demand for primary THAs by 2030 would rise up to 174% in USA. It is expected that the number of the elderly will surge significantly in the future, thus more septuagenarian and octogenarian are undergoing THA. Moreover, HALE of Japanese female near the age of 75 years, followed to Singapore, is still increasing. Therefore, concerns exist about the PROMs of performing THA in this age-group worldwide. Nevertheless almost the well-established procedure, little agreement has been reached to the elderly. We aimed to clarify the mid-term PROMs after THA over 75-year old. Between 2005 and 2013, we performed 720 consecutive primary cemented THAs through a direct lateral approach. Of these, 503 female patients (655 hips) underwent THA for treatment of osteoarthritis, with a minimum follow-up of 5 years, were retrospectively enrolled into the study. We excluded 191 patients (252 hips) aged less than 65-year at the time of surgery and 58 patients (60) because of post-traumatic arthritis or previous surgery (37), or lack of data (23). Thus, 343 hips remained eligible for our study, contributed by 254 patients. We investigated Quality-adjusted life year (QALY), EuroQol 5-Dimension 5-Level scale (EQ-5D) and the Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire (JHEQ, which was a disease-specific and self-administered questionnaire, reflecting the specificity of the Japanese cultural lifestyle) in patients aged 75 years or older (154 hips, Group-E) compared with those aged 65 to 74 years (189 hips, Group-C) retrospectively. We evaluated the association between patients aged 75 years or older and the following potential risk factors, using logistic regression analysis: age, number of vertebral fractures (VFs), American Society of Anesthesiologists physical status (ASA-PS) and Charlson Comorbidity Index (CCI). A Introduction
Methods
The purpose of the present study is to assess 5–10 years' follow-up results after acetabular impaction bone grafting (IBG) in primary cemented total hip arthroplasty (THA) for cases with acetabular bone defect. We performed 36 primary cemented THA with acetabular IBG in 33 patients between November 2004 and May 2009. As one patient died due to unrelated disease at 6 months after the surgery, 35 hips of 32 patients were included in this study. The average age at the surgery was 62.4 years, and the average follow-up period was 7.9 years (5–10 years). Diagnoses were osteoarthritis due to acetabular dysplasia in 28 hips (26 patients), Rheumatoid arthritis (RA) in 4 hips (3 patients), rapidly destructive coxopathy (RDC) in 1 hip (1 patient), idiopathic acetabular protrusion in 1 hip (1 patient), and acromegaly in 1 hip (1 patient). For clinical assessment, the Merle d'Aubigné and Postel hip score was assessed and degree of post-operative improvement was classified according to their method as very great improvement, great improvement, fair improvement, and failure. Perioperative complications were also recorded. Acetabular bone defects were assessed at the surgery and categorized using AAOS acetabular bone defect classification system. For radiological assessment, anteroposterior radiographs of the bilateral hip joints were analyzed preoperatively and post-operatively. Radiolucent lines (RLL) of more than 2 mm around the acetabular components were assessed using the DeLee and Charnley zone classification. Acetabular component loosening was assessed according to the Hodgkinson et al. classification system, and type 3 (complete demarcation line) and type 4 (migration) were classified as “loosening”.Purpose
Patients and methods
Orthopaedics has been earmarked as one of the specialties that could make significant savings in the National Health Service. A large number of young adults are receiving total hip replacements and there has been a trend towards using uncemented implants. We describe the clinical and functional results at minimum 19 year follow up of cemented total hip replacements in patients under the age of fifty-five in our health region between 1990 and 1997. 104 cemented THRs performed in 100 patients under 55 years were included in this study. The follow-up data had been collected prospectively in the University database. 88.46% hips showed good to excellent results at final follow-up with a mean Harris hip score of 87.9±8.64. Revision was performed in 2 hips (1.92%), one for aseptic acetabular loosening and the other for late haematogenous infection. Probable radiological loosening was seen in 14 acetabular components (14.89%) and 4 femoral components (4.25%) at final follow-up. The mean rate of acetabular wear was 0.12mm/year and was not influenced by gender or diagnosis. The mean follow-up was 21.68±2.11 years (range 19 to 26 years) and the survivorship at 19 years was 98.07%. The GIRFT report looked at the economic aspect of implant selection and found that the cost of uncemented implants was almost double that of the cemented implants. Savings of atleast £10 million a year can be made if cemented implants were used. We recommend that in a publically funded health system like the NHS, cemented implants can be used in patients under 55 with good long term functional outcomes and large savings in the healthcare costs.
Malalignment of some designs of stem is associated with an increased risk of aseptic loosening and revision. We investigated whether the alignment of the cemented polished, double-taper design adversely affected outcome, in a multicentre prospective study. A multicentre prospective study of 1189 total hip replacements was undertaken to investigate whether there is an association between surgical outcome and femoral stem alignment. All patients underwent a primary THR with the Exeter femoral stem (Stryker Howmedica Osteonics, Mahwah, NJ) and a variety of acetabular components. The primary outcome measure was the Oxford hip score (OHS) and change in OHS at five years. Secondary outcomes included rate of dislocation and revision. Radiographic evaluation of the femoral component was also undertaken. The long axis of the Exeter femoral component and the long axis of the femoral canal were located, and the angle at the point of intersection measured. The cementing quality was determined as defined by Barrack et al. Radiolucent lines at the cement-stem and cement-bone interface in the five year radiographs were defined using the zones described by Gruen et al. Subsidence was measured as the vertical dimension of the radiolucency craniolateral to the shoulder of the stem in Gruen zone 1 as described by Fowler et al. Cement fractures were recorded.Introduction
Methods
No relationship was seen between the BMI of an individual and the development of post-operative complications. The HHS was seen to increase dramatically postoperatively in all patients (mean 43 points at 18 months). BMI did predict for a lower HHS at 6 and 18 months and a lower physical functioning score on the SF-36.
Aim of our study was to analyze cortical bone changes in prosthetic hips with time and compare those changes with the contra lateral non operated femur.
10 patients were not operated on the contralateral hip and were measured in standardized manner in the same locations as in THA femurs.
Especially in young patients, total hip implants with proven long-term follow-up data should be used. Despite this, almost all patients under 30 years old will face a revision of their hip prosthesis during their life time because of their life expectancy. Therefore, all the used implants should be revisable with reliable outcome. Although, several studies have evaluated the outcome of different THA implants in patients under 30, only few report the long term follow-up of 10 years or more. None of them present the outcome of the revised total hips. We retrospectively reviewed prospectively collected data of 48 consecutive patients (69 hips), all received a cemented implant and in case of acetabular bone stock deficiency (29 hips), a reconstruction with bone impaction grafting (BIG) was performed. Mean age at surgery was 24.6 years (range, 16.0–29.0 years). Two patients were lost to follow-up. As far as we know, no revisions are performed in these two patients and their data are included in the study up to their last radiographic control. All failed hips were revised with again cemented implants and, if needed, bone impaction grafting. For the primary THA Kaplan-Meier survival curves at 10- and 15-year endpoint revision for any reason and revision for aseptic loosening were calculated. Separate survival rates at 10- and 15- year were calculated for the BIG group versus the non-BIG group. The outcome of the revised hips was studied and reported with re-revision as the endpoint.Introduction
Methods