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.

The direct superior approach (DSA) is a modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoined tendon during total hip arthroplasty (THA). The objective of this study was to compare postoperative pain, early functional rehabilitation, functional outcomes, implant positioning, implant migration, and complications in patients undergoing the DSA versus PA for THA.

This study included 80 patients with symptomatic hip arthritis undergoing primary THA. Patients were prospectively randomised to receive either the DSA or PA for THA, surgery was undertaken using identical implant designs in both groups, and all patients received a standardized postoperative rehabilitation programme. Predefined study outcomes were recorded by blinded observers at regular intervals for two-years after THA. Radiosteriometric analysis (RSA) was used to assess implant migration.

There were no statistical differences between the DSA and PA in postoperative pain scores (p=0.312), opiate analgesia consumption (p=0.067), and time to hospital discharge (p=0.416). At two years follow-up, both groups had comparable Oxford hip scores (p=0.476); Harris hip scores (p=0.293); Hip disability and osteoarthritis outcome scores (p=0.543); University of California at Los Angeles scores (p=0.609); Western Ontario and McMaster Universities Arthritis Index (p=0.833); and European Quality of Life questionnaire with 5 dimensions scores (p=0.418). Radiographic analysis revealed no difference between the two treatment groups for overall accuracy of acetabular cup positioning (p=0.687) and femoral stem alignment (p=0.564). RSA revealed no difference in femoral component migration (p=0.145) between the groups at two years follow-up.

There were no differences between patients undergoing the DSA versus PA for THA with respect to postoperative pain scores, functional rehabilitation, patient-reported outcome measurements, accuracy of implant positioning, and implant migration at two years follow-up. Both treatment groups had excellent outcomes that remained comparable at all follow-up intervals.

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.

The purpose of this randomized controlled trial was to evaluate serum metal levels in patients undergoing total hip arthroplasty (THA) with a conventional compared to a modular dual-mobility bearing.

Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or conventional polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Serum metal levels were drawn pre-operatively then annually for a minimum of two years postoperatively. An a priori power analysis determined that 40 patients (20 per cohort) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power.

Forty-six patients were randomized to a modular dual-mobility (n=25) or conventional bearing (n=21) with 40 at a minimum follow-up of two years. No differences in serum cobalt (mean 0.14 ppb [range, 0.075–0.29] vs. 0.20 ppb [range, 0.075–0.57], p=0.39) or chromium levels (mean 0.14 ppb [range, 0.05–0.50] vs. 0.12 ppb [range, 0.05–0.35], p=0.65) were identified between the modular dual-mobility and conventional cohorts, respectively.

There was no statistically significant difference in serum Co or Cr at two years postoperatively in subjects implanted with a ceramic head and this particular dual mobility bearing in comparison to a ceramic head and a conventional acetabular component. While modest expected elevations in serum Co and Cr were observed in the dual mobility group, in no case did the Co level exceed the laboratory reference range nor the threshold of one part per billion that has been associated with adverse local tissue reactions to mechanically-assisted crevice corrosion.

We present minimum 20 year results of a randomized, prospective double blinded trial (RCT) of cross-linked versus conventional polyethylene (PE), using a computer assisted method of PE wear measurement.

After Ethics Committee approval, 122 patients were enrolled into an RCT comparing Enduron (non cross-linked PE) and highly cross-linked Marathon PE (DePuy, Leeds, UK). Other than the PE liners, identical components were used, a Duraloc 300 metal shell with one screw, a 28mm CoCr femoral head and a cemented Charnley Elite femoral stem. All patients were followed with anteroposterior (A∼P) and lateral radiographs at 3 days, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 10 and 20 years. PE wear was measured with PolyMig, which has a phantom validated accuracy of ± 0.09mm.

At minimum 20 year follow-up, 47 patients had died, 5 of which had been revised prior to their death. Another 32 patients were revised and alive, leaving 43 patients unrevised and alive (15 Enduron, 28 Marathon). No patients were lost to follow-up, but 2 were not able to be radiographed (dementia), leaving 41 patients (15 Enduron, 26 Marathon) available for PE wear measurement. After the bedding-in period, Enduron liners had a wear rate of 0.182 mm/year, and Marathon liners had a wear rate of 0.028 mm/year. At 20 years follow-up, 37 patients had required revision. Patients with conventional PE had three times the revision rate (28/37) of those who received XLPE (9/37).

This is the longest term RCT showing substantially improved clinical and radiological results when XLPE is used as the bearing surface.

Femoral stem design affects periprosthetic bone mineral density (BMD), which may impact long term survival of cementless implants in total hip arthroplasty (THA). The aim of this study was to examine proximal femoral BMD in three morphologically different uncemented femoral stems designs to investigate whether one particular design resulted in improved preservation of BMD.

119 patients were randomized to receive either a proximally coated dual taper wedge stem, a proximally coated anatomic stem or a fully coated collarless triple tapered stem. Dual energy x-ray absorptiometry scans (Lunar iDXA, GE Healthcare, Madison, WI) assessed BMD across the seven Gruen zones pre-operatively, and post-operatively at 6-weeks, 1-year, and 2-years comparing the unoperated contralateral femur as a control.

BMD increased in zones one (2.5%), two (17.1%), three (13.0%), five (10%) and six (17.9%) for all stems. Greater preservation of BMD was measured on the lateral cortex (zone 2) for both the dual taper wedge and anatomic stems (p = 0.019). The dual taper wedge stem also demonstrated preservation of BMD in the medial calcar (zone 7) whilst the anatomic and triple taper stem declined in this region, however this was not statistically significant (p = 0.059). BMD decreased on average by 2.1% in the mid-diaphysis region, distal to the stem tip (zone 4) for all implants. All stems performed equivalently at final follow-up in all patient reported outcome measures.

Implant design was shown to impact BMD changes. All stems preserved bone at the metaphyseal level in early follow-up, which theoretically indicates favorable implant fixation. There was no significant stress shielding observed, however longer follow-up is required to elucidate the impact of this finding on implant survivorship.

Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients.

This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures.

Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8.

This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options.

There is an increasing incidence of revision for periprosthetic joint infection. The addition of vancomycin to beta-lactam antimicrobial prophylaxis in joint arthroplasty may reduce surgical site infections, however, the efficacy and safety have not been established.

This was a multicenter, double-blind, superiority, placebo-controlled trial. We randomized 4239 adult patients undergoing joint arthroplasty surgery to receive 1.5g vancomycin or normal saline placebo, in addition to standard cefazolin antimicrobial prophylaxis. The primary outcome was surgical site infection at 90-days from index surgery. Perioperative carriage of Staphylococcus species was also assessed.

In the 4113 patients included in the modified intention-to-treat population, surgical site infections occurred in 72/2069 (3.5%) in the placebo group and 91/2044 (4. 5%) in the vancomycin group (risk ratio 1.28; 95% confidence interval 0.94 to 1.73; p value 0.11). No difference was observed between the two groups for primary hip arthroplasty procedures. A higher proportion of infections occurred in knee arthroplasty patients in the vancomycin group (63/1109 [4.7%]) compared with the placebo group (42/1124 [3.7%]; risk ratio 1.52; 95% confidence interval 1.04 to 2.23; p value 0.031). Hypersensitivity reactions occurred in 11 (0.5%) patients in the placebo group and 24 (1.2%) in the vancomycin group (risk ratio 2.20; 95% confidence interval 1.08, 4.49) and acute kidney injury in 74 (3.7%) patients in the placebo group and 42 (2.1%) in the vancomycin group (risk ratio 0.57; 95% confidence interval 0.39, 0.83). Perioperative Staphylococcus aureus carriage was detected in 1089/3748 (29.1%) of patients.

This is the first randomized controlled trial examining the addition of a glycopeptide antimicrobial to standard beta-lactam surgical antimicrobial prophylaxis in joint arthroplasty. The addition of vancomycin to standard cefazolin prophylaxis was not superior to placebo for the prevention of surgical site infections in hip and knee arthroplasty surgery.

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.

Patients undergoing total hip or knee arthroplasty (THA/TKA) are commonly associated with high pain scores and narcotic use. Duloxetine is effective in relieving chronic pain. The aim of this study was to evaluate the safety and efficacy of duloxetine for pain management following THA/TKA.

Five major databases (PubMed, Embase, Scopus, Cochrane, and Web of Science) were searched for randomised controlled trials (RCTs) that compared duloxetine to placebo in patients that underwent THA/TKA. The primary outcome was pain reduction with rest and movement at short-term and long-term time intervals. Secondary outcomes were the use of analgesics, length of stay, and safety profile. The risk of bias was assessed using the Cochrane tool. Data were pooled using RevMan 5.4. The results were reported as mean difference (MD) or standardised MD (SMD) and 95% confidence intervals (CI).

Eight RCTs with 767 patients were included. 50.2% (n=385/767) of patients received duloxetine. After one day, duloxetine was superior to the control regarding pain reduction with rest (SMD= −0.22 [−0.41, −0.03], p=0.02) after sensitivity analysis and pain reduction at movement (SMD= −0.39 [−0.55, −0.24], p<0.001). Similarly, after 12 weeks, duloxetine significantly reduced pain with rest (SMD= −0.3 [−0.52, −0.09], p=0.006) and pain with movement (SMD= −0.52 [−0.87, −0.17], p=0.003). In addition, after sensitivity analysis, duloxetine was associated with less analgesic use after one day (MD= −4.65 [−7.3, −2.01], p<0.001) and two days (MD= −5.65 [−10.62, −0.67], p=0.03). Patients who received duloxetine also required fewer analgesics after three days. However, there was no significant difference between the duloxetine and control groups in analgesic use after one week, length of stay, and adverse events.

Duloxetine was superior to the placebo regarding short-term and long-term pain reduction with rest and movement following THA/TKA. Duloxetine reduced postoperative analgesic use. There was no significant difference between duloxetine and placebo regarding adverse events and length of stay.

Superior teamwork in the operating theatre is associated with improved technical performance and clinical outcomes. Yet modern rota patterns, workforce shortages, and increasing complexity of surgery, means that there is less familiarity between staff and the required choreography. Immersive Virtual Reality (iVR) can successfully train surgical staff individually, however iVR team training has yet to be investigated. We aimed to design a multiplayer iVR platform for anterior approach total hip arthroplasty (AA-THA) and assess if multiplayer iVR training was superior to single player training for acquisition of both technical and non-technical skills.

An iVR platform with choreographed roles for the surgeon and scrub nurse was developed using Cognitive Task Analysis. Forty participants were randomised to individual or team iVR training. Individually- trained participants practiced alongside virtual avatar counterparts, whilst teams trained live in pairs. Both groups underwent five iVR training sessions over 6-weeks. Subsequently, they underwent a real-life assessment in which they performed AA-THA on a high-fidelity model with real equipment in a simulated theatre. Teams performed together and individually trained participants were randomly paired up. Videos were marked by two blinded assessors recording the NOTSS, NOTECHS II and SPLINTS scores - validated technical and non-technical scores assessing surgeon and scrub nurse skills. Secondary outcomes were procedure time and number of technical errors.

Teams outperformed individually trained participants for non-technical skills in the real-world assessment (NOTSS 13.1 ± 1.5 vs 10.6 ± 1.6, p =0.002, NOTECHS-II score 51.7 ± 5.5 vs 42.3 ± 5.6, p=0.001 and SPLINTS 10 ± 1.2 vs 7.9 ± 1.6, p = 0.004). They completed the assessment 28.1% faster (27.2 minutes ± 5.5 vs 41.8 ±8.9, p<0.001), and made fewer than half the number of technical errors (10.4 ± 6.1 vs 22.6 ± 5.4, p<0.001).

Multiplayer training leads to faster surgery with fewer technical errors and the development of superior non-technical skills for anterior approach total hip arthroplasty. The convention of surgeons and nurses training separately, but undertaking real complex surgery together, can be supplanted by team training, delivered through immersive virtual reality.

Superior team performance in surgery leads to fewer technical errors, reduced mortality, and improved patient outcomes. Scrub nurses are a pivotal part of this team, however they have very little structured training, leading to high levels of stress, low confidence, inefficiency, and potential for harm. Immersive virtual reality (iVR) simulation has demonstrated excellent efficacy in training surgeons. We tested the efficacy of an iVR curriculum for training scrub nurses in performing their role in an anterior approach total hip arthroplasty (AA-THA).

Sixty nursing students were included in this study and randomised in a 1:1 ratio to learning the scrub nurse role for an AA-THA using either conventional training or iVR. The training was derived through expert consensus with senior surgeons, scrub nurses and industry reps. Conventional training consisted of a 1-hour seminar and 2 hours of e-learning where participants were taught the equipment and sequence of steps. The iVR training involved 3 separate hour-long sessions where participants performed the scrub nurse role with an avatar surgeon in a virtual operation. The primary outcome was their performance in a physical world practical objective assessment with real equipment. Data were confirmed parametric using the Shapiro-Wilk test and means compared using the independent samples student's t-test.

53 participants successfully completed the study (26 iVR, 27 conventional) with a mean age of 31±9 years. There were no significant differences in baseline characteristics or baseline knowledge test scores between the two groups (p>0.05). The iVR group significantly outperformed the conventionally trained group in the real-world assessment, scoring 66.9±17.9% vs 41.3±16.7%, p<0.0001.

iVR is an easily accessible, low cost training modality which could be integrated into scrub nursing curricula to address the current shortfall in training. Prolonged operating times are strongly associated with an increased risk of developing serious complications. By upskilling scrub nurses, operations may proceed more efficiently which in turn may improve patient safety.

In metal-on-polyethylene (MoP) THA large femoral metal heads are designed to increase stability and to reduce dislocation risk. The increased head size could lead to increased taper corrosion with the release of metal ions and adverse reactions. Using blood ion measurements, we aimed to investigate the association between femoral head size and metal-ion release after MoP THA.

96 patients were enrolled at two centers and randomized to receive either a 32-mm metal head or a 36–44 mm metal head (the largest possible fitting the thinnest available polyethylene insert). Blood metal ions and PROMs (OHS, UCLA) were measured at two- and five-year follow-ups.

Both 2- and 5-year median chrome, cobalt, and titanium levels were below taper corrosion indicative ion levels. At 5 years, median chrome, cobalt, and titanium levels were 0.5 μg/L (0.50–0.62), 0.24 μg/L (0.18–0.30), and 1.16 μg/L (1.0–1.68) for the 32-mm group, and 0.5 μg/L (0.5–0.54), 0.23 μg/L (0.17–0.39), and 1.30 μg/L (1–2.05) for the 36–44 mm group, with no difference between groups (p=0.825, p=1.000, p=0.558). At 2 years, 7 (32-mm) versus 4 (36–44-mm) patients had elevated ions. At 5 years, 6 (32-mm) versus 7 (36–44-mm) patients had elevated ions. There was no difference in either OHS (p=0.665) or UCLA (p=0.831) between patients with or without elevated blood metal ions.

5 years after the insertion of MoP THAs, we found no differences in the blood metal ion levels between 32 mm heads and 36–44 mm heads and no corrosion-related revisions. As taper corrosion can debut after 5 years, there is still a need for long-term follow-up studies on the association between head size and corrosion in MoP THA.

Proximal hamstring tendon avulsion from the ischial tuberosity is a significant injury, with surgical repair shown to have superior functional outcomes compared to non-surgical treatment. However, limited data exists regarding the optimal rehabilitation regime following surgical repair. The aim of this study was to investigate patient outcomes following repair of proximal hamstring tendon avulsions between a conservative (CR) versus an accelerated rehabilitation (AR) regimen.

This prospective randomized controlled trial (RCT) randomised 50 patients undergoing proximal hamstring tendon repair to either a braced, partial weight-bearing rehabilitation regime (CR=25) or an accelerated, unbraced regime, that permitted full weight-bearing as tolerated (AR=25).

Patients were evaluated pre-operatively and at 3 and 6 months post-surgery, via patient-reported outcome measures (PROMs) including the Lower Extremity Functional Scale (LEFS), Perth Hamstring Assessment Tool (PHAT) and 12-item Short Form Health Survey (SF-12). Primary analysis was per protocol and based on linear mixed models.

Both groups were matched at baseline with respect to patient characteristics. All PROMs improved (p>0.05) and, while the AR group reported a significantly better Physical Component Score for the SF-12 at 3 months (p=0.022), there were no other group differences. Peak isometric hamstrings strength and peak isokinetic quadriceps and hamstrings torque symmetry were all comparable between groups (p>0.05). Three re-injuries have been observed (CR=2, AR=1).

After proximal hamstring repair surgery, post-operative outcomes following an accelerated rehabilitation regimen demonstrate comparable outcomes to a traditionally conservative rehabilitation pathway, albeit demonstrating better early physical health-related quality of life scores, without an increased incidence of early re-injury.

The primary treatment goal for patients with femoroacetabular impingement syndrome, a common hip condition in athletes, is to improve pain and function. In selected patients, in the short term following intervention, arthroscopic hip surgery is superior to a pragmatic NHS- type physiotherapy programme. Here, we report the three-year follow-up results from the FemoroAcetabular Impingement Trial (FAIT), comparing arthroscopic hip surgery with physiotherapy in the management of patients with femoroacetabular impingement (FAI) syndrome.

Two-group parallel, assessor-blinded, pragmatic randomised controlled study across seven NHS England sites. 222 participants aged 18 to 60 years with FAI syndrome confirmed clinically and radiologically were randomised (1:1) to receive arthroscopic hip surgery (n = 112) or physiotherapy and activity modification (n = 110). We previously reported on the hip outcome score at eight months. The primary outcome measure of this study was minimum Joint Space Width (mJSW) on Anteroposterior Radiograph at 38 months post randomisation. Secondary outcome measures included the Hip Outcome Score and Scoring Hip Osteoarthritis with MRI (SHOMRI) score.

Minimum Joint Space Width data were available for 101 participants (45%) at 38 months post randomisation. Hip outcome score and MRI data were available for 77% and 62% of participants respectively. mJSW was higher in the arthroscopy group (mean (SD) 3.34mm (1.01)) compared to the physiotherapy group (2.99mm (1.33)) at 38 months, p=0.017, however this did not exceed the minimally clinically important difference of 0.48mm. SHOMRI score was significantly lower in the arthroscopy group (mean (SD) 9.22 (11.43)) compared to the physiotherapy group (22.76 (15.26)), p-value <0.001. Hip outcome score was higher in the arthroscopy group (mean (SD) 84.2 (17.4)) compared with the physiotherapy group (74.2 (21.9)), p-value < 0.001).

Patients with FAI syndrome treated surgically may experience slowing of osteoarthritisprogression and superior pain and function compared with patients treated non- operatively.

Extracapsular Hip Fractures (EHF's) are a significant health burden on healthcare services. Optimal treatment is controversial with conflicting evidence being reported. Currently treatment is undertaken with Intramedullary Nail (IMN) or Dynamic Hip Screw (DHS) constructs with a recent increase in IMN use (1). This study aims to conduct a systematic review of Randomised Control Trials published between 2020 and 2023 with particular focus on patient demographics and holistic patient outcomes.

Using a unified search-protocol, RCT's published between 2020 and 2023 were collected from CENTRAL, PubMed, MEDLINE and EMBASE. Rayyan software screened duplicates. Using the CASP and Cochrane Risk of Bias Tool papers were critically examined twice, and Blood Loss, Infection and Mobility described the patient journey. Patient demographics were recorded and were contrasted with geographically diverse cohort studies to compare population differences. Parametric tests were used to determine significance levels between population demographics, namely Age and Sex.

Eleven papers were included, representing 908 patients (436 Male). The mean age for patients was 64.39. There was considerable risk of bias in 7/11 studies owing to the randomization process and the recording of data. Four Cohort studies were selected for comparison representing 14314 patients. Mean age was significantly different between Cohort Studies and RCT's (Independent T-Test, df 13, t=7.8, p = <0.001, mean difference = 19.251, 95% CI = 13.888, 24.613). This was also true for sex ratios included in the studies (df 13, t = -2.268, p = 0.024, Mean Difference = -0.4884, 95% CI = -0.9702, -0.0066).

To conclude, RCT's published in the post COVID-19 era are not representative of patient demographics. This has the potential to provide inaccurate information for implant selection. Additionally further research must be conducted in how to better improve RCT patient inclusion so as to be more representative of patients whilst balancing the risks of operations.

The purpose of this randomized controlled trial was to evaluate serum metal ion levels in patients undergoing THA with either a standard or modular dual-mobility bearing.

Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or a standard polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Only patients without a prior history of metal implants in their body were eligible for inclusion, thus isolating serum metal ions to the prosthesis itself. Serum metal ion levels were drawn pre-operatively and at 1 year postoperatively. Power analysis determined that 40 patients (20 in each group) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power assuming a pooled standard deviation of 0.31 ppb and alpha=0.05; an additional 30% were enrolled to account for potential dropouts.

53 patients were enrolled, with 22 patients in the modular dual-mobility group and 20 in the standard cohort with data available at one-year. No differences in the serum cobalt (0.17 ppb [range 0.07 to 0.50] vs. 0.19 ppb [range 0.07 to 0.62], p = 0.51) or chromium levels (0.19 ppb [range 0.05 to 0.56] vs. 0.16 ppb [range 0.05 to 0.61], p = 0.23) were identified.

At 1 year postoperatively, no differences in serum cobalt or chromium levels were identified with this design of a modular dual mobility bearing when compared to a standard polyethylene bearing.

Vitamin E-doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in a thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA.

96 candidates for uncemented THA were randomly allocated to either the largest possible metal head (36–44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration (PHP) measured with model-based radiostereometric analysis (RSA). Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The mid-term results of the trial at 5 years are presented.

Median total PHP (interquartile range) was -0.04 mm (−0.12 to 0.02) in the intervention group and -0.03 mm (=0.14 to 0.05) in the control group (p=0.691). The rates of periacetabular radiolucencies were 1/44 and 4/42 (p=0.197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median UCLA rank 7 vs 6, p=0.020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1).

Large metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.

This study reports the ten-year polyethylene liner wear rates, incidence of osteolysis, clinical outcomes and complications of a three-arm, multicentre randomised controlled trial comparing Cobalt-Chrome (CoCr) and Oxidised Zirconium (OxZr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA).

Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and XLPE liner; Group B received an OxZr femoral head and XLPE liner; and Group C received an OxZr femoral head and UHMWPE liner. Blinded observers recorded predefined outcomes in 262 study patients at regular intervals for ten years following THA.

At ten years follow-up, increased linear wear rates were recorded in group C compared to group A (0.133 ± 0.21 mm/yr vs 0.031 ± 0.07 mm/yr respectively, p<0.001) and group B (0.133 ± 0.21 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p<0.001). Patients in group C were associated with increased risk of osteolysis and aseptic loosening requiring revision surgery compared with group A (7/133 vs 0/133 respectively, p=0.007) and group B (7/133 vs 0/135 respectively, p=0.007). There was a non-significant trend towards increased liner wear rates in group A compared to group B (0.031 ± 0.07 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p=0.128). All three groups were statistically comparable preoperatively and at ten years follow-up when measuring normalised Western Ontario and McMaster Universities Osteoarthritis Index(p=0.410), short-form-36 (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p=0.451).

The use of UHMWPE was associated with progressively increased annual liner wear rates after THA. At ten years follow-up, this translated to UHMWPE leading to an increased incidence of osteolysis and aseptic loosening requiring revision THA, compared with XLPE. Femoral heads composed of OxZr were associated with a non-significant trend towards reduced wear rates compared to CoCr, but this did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two treatments groups.

Total hip arthroplasty (THA) is one of the most successful surgical procedures of modern times, however debate continues as to the optimal orientation of the acetabular component and how to reliably achieve this. We hypothesised that functional CT-based planning with patient specific instruments using the Corin Optimised Positioning System (OPS) would provide more accurate component alignment than the conventional freehand technique using 2D templating.

A pragmatic single-centre, patient-assessor blinded, randomised control trial of patients undergoing THA was performed. 54 patients (age 18–70) were recruited to either OPS THA or conventional THA. All patients received a cementless acetabular component. Patients in both arms underwent pre- and post-operative CT scans, and four functional x-rays (standing and seated). Patients in the OPS group had a 3D surgical plan and bespoke guides made. Patients in the conventional group had a surgical plan based on 2D templating x-rays, and the pre-operative target acetabular orientation was recorded by the surgeon. The primary outcome measure was the difference between planned and achieved acetabular anteversion and was determined by post-operative CT scan performed at 6 weeks. Secondary outcome measures included Hip disability and Osteoarthritis Outcome Score (HOOS), Oxford Hip Score (OHS), EQ-5D and adverse events.

In the OPS group, the achieved acetabular anteversion was within 10° of the plan in 96% of cases, compared with only 76% of cases in the conventional group. For acetabular inclination, the achieved position in the OPS group was within 10° of the plan in 96% of cases, compared with in only 84% of cases in the conventional group. These differences were not statistically significant. The clinical outcomes were comparable between the two groups.

Large errors in acetabular orientation appear to be reduced when functional CT-based planning and patient-specific instruments are used compared to the freehand technique, but no statistically significant differences were seen in the difference between planned and achieved angles. Larger studies are needed to analyse this in more detail and to determine whether the reduced numbers of outliers lead to improved clinical outcomes.