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Aim. Decubitus ulcers are found in approximately 4.7% of hospitalized patients, with a higher prevalence (up to 30%) among those with spinal cord injuries. These ulcers are often associated with hip septic arthritis and/or osteomyelitis involving the femur. Girdlestone resection arthroplasty is a surgical technique used to remove affected proximal femur and acetabular tissues, resulting in a substantial defect. The vastus lateralis flap has been employed as an effective option for managing this dead space. The aim of this study was to evaluate the long-term outcomes of this procedure in a consecutive series of patients. Method. A retrospective single-center study was conducted from October 2012 to December 2022, involving 7 patients with spinal cord injuries affected by chronic severe septic hip arthritis and/or femoral head septic necrosis as a consequence of decubitus ulcers over trochanter area. All patients underwent treatment using a multidisciplinary approach by the same surgical team (orthopedic and plastic surgeons) along with infectious disease specialists. The treatment consisted of a one-stage procedure combining Girdlestone resection arthroplasty with unilateral vastus lateralis flap reconstruction, alongside targeted antibiotic therapy. Complications and postoperative outcomes were assessed and recorded. The mean follow-up period was 8 years (range 2-12). Results. Of the 7 patients, 5 were male and 2 were female, with a mean age of 50.3 years at the time of surgery. Minor wound dehiscence occurred in 28.6% of the flap sites, and 2 patients required additional revisional procedures—one for hematoma and the other for bleeding. There were no instances of flap failure, and complete wound healing was achieved in an average of 32 days (range 20-41), with the ability to load over the hip area. No cases of infection recurrence or relapse were observed. Conclusions. An aggressive surgical approach is strongly recommended for managing chronic hip septic arthritis or proximal femur osteomyelitis in patients with spinal cord injuries. A single-stage procedure combining Girdlestone resection arthroplasty with immediate vastus lateralis muscle flap reconstruction proves to be an effective strategy for dead space management and localized antibiotic delivery through the vastus muscle, giving reliable soft tissue coverage around the proximal femur to avoid the recurrence of pressure ulcers. The implementation of a standardized multidisciplinary protocol contributes significantly to the success of reconstruction efforts


Bone & Joint Open
Vol. 5, Issue 10 | Pages 837 - 843
7 Oct 2024
Zalikha AK Waheed MA Twal C Keeley J El-Othmani MM Hajj Hussein I

Aims

This study aims to evaluate the impact of metabolic syndrome in the setting of obesity on in-hospital outcomes and resource use after total joint replacement (TJR).

Methods

A retrospective analysis was conducted using the National Inpatient Sample from 2006 to the third quarter of 2015. Discharges representing patients aged 40 years and older with obesity (BMI > 30 kg/m2) who underwent primary TJR were included. Patients were stratified into two groups with and without metabolic syndrome. The inverse probability of treatment weighting (IPTW) method was used to balance covariates.


Bone & Joint 360
Vol. 13, Issue 5 | Pages 28 - 30
1 Oct 2024

The October 2024 Foot & Ankle Roundup360 looks at: Hemiarthroplasty for hallux rigidus; Fixed or mobile-bearing ankle arthroplasty? A meta-analysis; Bone grafting for periprosthetic bone cysts following total ankle arthroplasty; Diabetic foot ulcer after first-ray amputation; Early motion after ankle surgery: the path to faster recovery?; Are podiatrists and orthopaedic surgeons approaching zone 2 fifth metatarsal fractures in the same way?.


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1044 - 1049
1 Oct 2024
Abelleyra Lastoria DA Ogbolu C Olatigbe O Beni R Iftikhar A Hing CB

Aims

To determine whether obesity and malnutrition have a synergistic effect on outcomes from skeletal trauma or elective orthopaedic surgery.

Methods

Electronic databases including MEDLINE, Global Health, Embase, Web of Science, ScienceDirect, and PEDRo were searched up to 14 April 2024, as well as conference proceedings and the reference lists of included studies. Studies were appraised using tools according to study design, including the Oxford Levels of Evidence, the Institute of Health Economics case series quality appraisal checklist, and the CLARITY checklist for cohort studies. Studies were eligible if they reported the effects of combined malnutrition and obesity on outcomes from skeletal trauma or elective orthopaedic surgery.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 986 - 993
1 Sep 2024
Hatano M Sasabuchi Y Isogai T Ishikura H Tanaka T Tanaka S Yasunaga H

Aims

The aim of this study was to compare the early postoperative mortality and morbidity in older patients with a fracture of the femoral neck, between those who underwent total hip arthroplasty (THA) and those who underwent hemiarthroplasty.

Methods

This nationwide, retrospective cohort study used data from the Japanese Diagnosis Procedure Combination database. We included older patients (aged ≥ 60 years) who underwent THA or hemiarthroplasty after a femoral neck fracture, between July 2010 and March 2022. A total of 165,123 patients were included. The THA group was younger (mean age 72.6 (SD 8.0) vs 80.7 years (SD 8.1)) and had fewer comorbidities than the hemiarthroplasty group. Patients with dementia or malignancy were excluded because they seldom undergo THA. The primary outcome measures were mortality and complications while in hospital, and secondary outcomes were readmission and reoperation within one and two years after discharge, and the costs of hospitalization. We conducted an instrumental variable analysis (IVA) using differential distance as a variable.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 949 - 956
1 Sep 2024
Matthews PA Scammell BE Coughlin TA Nightingale J Ollivere BJ

Aims

This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme.

Methods

A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 849 - 857
1 Aug 2024
Hatano M Sasabuchi Y Ishikura H Watanabe H Tanaka T Tanaka S Yasunaga H

Aims

The use of multimodal non-opioid analgesia in hip fractures, specifically acetaminophen combined with non-steroidal anti-inflammatory drugs (NSAIDs), has been increasing. However, the effectiveness and safety of this approach remain unclear. This study aimed to compare postoperative outcomes among patients with hip fractures who preoperatively received either acetaminophen combined with NSAIDs, NSAIDs alone, or acetaminophen alone.

Methods

This nationwide retrospective cohort study used data from the Diagnosis Procedure Combination database. We included patients aged ≥ 18 years who underwent surgery for hip fractures and received acetaminophen combined with NSAIDs (combination group), NSAIDs alone (NSAIDs group), or acetaminophen alone (acetaminophen group) preoperatively, between April 2010 and March 2022. Primary outcomes were in-hospital mortality and complications. Secondary outcomes were opioid use postoperatively; readmission within 90 days, one year, and two years; and total hospitalization costs. We used propensity score overlap weighting models, with the acetaminophen group as the reference group.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 550 - 559
5 Jul 2024
Ronaldson SJ Cook E Mitchell A Fairhurst CM Reed M Martin BC Torgerson DJ

Aims

To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS).

Methods

A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 14 - 14
17 Jun 2024
Johnson-Lynn S Curran M Allen C Webber K Maes M Enoch D Robinson A Coll A
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Introduction. Diabetic foot disease is a major public health problem with an annual NHS expenditure in excess of £1 billion. Infection increases risk of major amputation fivefold. Due to the polymicrobial nature of diabetic foot infections, it is often difficult to isolate the correct organism with conventional culture techniques, to deliver appropriate narrow spectrum antibiotics. Rapid DNA-based technology using multi-channel arrays presents a quicker alternative and has previously been used effectively in intensive care and respiratory medicine. Methods. We gained institutional and Local Ethics Committee approval for a prospective cohort study of patients with clinically infected diabetic foot wounds. They all had deep tissue samples taken in clinic processed with conventional culture and real-time PCR TaqMan array. Results. 50 samples were taken from 39 patients between October 2020 and March 2022. 84% of patient were male, 88% had type 2 diabetes. The ulcers were of variable chronicity prior to sampling (range 1–113 weeks) and mean HbA1c was 67.2mmol/mol. Ulcers were on the heel (3), midfoot (6) and forefoot (41). Minimum follow up was 3 months. 6 ulcers healed, 24 patients were admitted due to foot disease, there were 2 major amputations and 4 deaths. TaqMan array results were available a mean of 4.3 days earlier than culture results. 9 patients had negative conventional cultures and 8 were negative onarray testing. 17 patients had the same organisms detected on culture and array. 16 of these 17 had additional organisms detected by array. The most frequent organisms detected on array that were not detected by culture were Staphylococcus spp., Enterobacter, Pseudomonas and fungi. Conclusion. TaqMan array shows promise in detecting infecting organisms from diabetic foot wounds and providing earlier results than standard culture, which may enable appropriate and timely antibiotic therapy


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 16 - 16
17 Jun 2024
Sayani J Tiruveedhula M
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Aim. Forefoot ulcers in patients with diabetic neuropathy are a result of factors that result in increased forefoot plantar pressures. Progressive hindfoot equinus from contraction of gastrocnemius-soleus-tendo-Achilles complex and progressive plantar flexed metatarsal heads secondary to claw toe deformity results callus at the metatarsal heads which break down to ulceration. The aim is to describe 2-stage treatment pathway for managing these ulcers. Methods. Consecutive patients, who presented with forefoot ulcers since February 2019 were treated with a 2-stage treatment pathway. The first stage of this is an out-patient tendo-Achilles lengthening (TAL). The second stage is surgical proximal dorsal closing wedge metatarsal osteotomy for patients with persistent or recurrent ulcers. Patients were followed for a minimum of 12 months. Results. 112 patients (146 feet) underwent TAL by 3 consultants. Of these, 96 patients were followed for a minimum of 12 months (range 12–36 months). None had infection or wound related problems at the tenotomy sites; complete transection of the tendon was noted in 4 patients (4%) and one-patient developed heel callosity suggestive of over-lengthening. In 92 patients (96%), the ulcers healed within 10 weeks (± 4 weeks). Additional z-lengthening of peroneal longus and tibialis posterior tendons helped in patients with 1. st. metatarsal and 5. th. metatarsal head ulcers respectively. In 12 patients (10%), the ulcer failed to heal or recurred. MRI scan in these patients showed plantar flexed metatarsals from progressive claw toe deformity. The ulcer in this group healed after surgical offloading with proximal dorsal closing wedge osteotomy of the metatarsal/s, with no recurrence at a minimum 12months of follow-up. Conclusion. The described 2-stage treatment pathway results in long-term healing of neuropathic forefoot ulcers, and in 96% of patients, the ulcer healed after the first stage out-patient percutaneous TAL


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 9 - 9
16 May 2024
Galhoum A Abd-Ella M ElGebeily M Rahman AA Zahlawy HE Ramadan A Valderrbano V
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Background. Charcot neuroarthropathy is a destructive disease characterized by progressive bony fragmentation as a result of the isolated or accumulative trauma in patients with decreased sensation that manifests as dislocation, periarticular fractures and instability. Although amputation can be a reasonable cost economic solution, many patients are willing to avoid that if possible. We explored here one of the salvage procedures. Methods. 23 patients with infected ulcerated unstable Charcot neuroarthropathy of the ankle were treated between 2012 and 2017. The mean age was 63.5 ±7.9 years; 16 males and 7 females. Aggressive open debridement of ulcers and joint surfaces, with talectomy in some cases, were performed followed by external fixation with an Ilizarov frame. The primary outcome was a stable plantigrade infection free foot and ankle that allows weight bearing in accommodative foot wear. Results. Limb salvage was achieved in 91.3% of cases at the end of a mean follow up time of 25 months (range: 19–32). Fifteen (71.4%) solid bony unions were evident clinically and radiographically, while 6 (28.5%) patients developed stable painless pseudoarthrosis. Two patients had below knee amputations due to uncontrolled infection. Conclusion. Aggressive debridement and arthrodesis with ring external fixation can be used successfully to salvage severely infected Charcot arthropathy of the ankle. Pin tract infection, delayed wound healing and stress fracture may complicate the procedure but can be easily managed. Amputation may be the last resort in uncontrolled infection


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_9 | Pages 8 - 8
16 May 2024
Giddie J Phyo N Reichert I Ahluwalia R Kavarthapu V
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Background. Corrective fusion of a deformed / unstable Charcot neuroarthropathy (CN)of the midfoot and hindfoot is performed with the aim to prevent ulcers and maintain patient mobility. Methods. Between October 2007 and July 2018, 103 CN mid and hind foot corrections in 95 patients were performed. There were 34 hind-foot, 38 mid-foot and 31 combined hind and mid-foot surgeries. 83 feet had single stage corrections, whereas 20 required a staged operation. Results. Ninety-five patients were prospectively followed up. The mean patient age in our study was 57 years (21 – 85). Twenty-seven patients had type1 diabetes, 64 patients had type 2 and 4 patients had a neuropathy secondary to other conditions. Forty patients (42%) were offered a below knee amputation prior to attending our foot clinic. At a mean follow up of 56 months (12 – 140) we achieved 100% limb salvage with a 75% full bone fusion rate. There were 17 mortalities within our cohort at a mean period of 3 years. Ninety-seven percent (n=92) patients were mobilizing post-operatively in orthotic footwear. Fifty-two feet had pre-operative ulcers. Post-operatively 17 feet (16 patients) had persistent ulceration. Eight patients had ulcer resolution following further surgery and alteration of footwear, one patient has been listed for a below knee amputation for unstable non-union, whilst the remaining 7 patients have stable ulcers which are managed with dressings. Of the 26 feet (25 patients) with non-unions, 6 patients had revision fixation procedures whilst 8 patients required minor surgical procedures. The remaining 11 patients are stable non-unions who are asymptomatic and weight bearing. Other complications included a deep infection rate of 8% (n=7). Conclusion. We demonstrated a 100% limb salvage rate and an 83% success rate in ulcer resolution. We recommend this be done with the support of the multi-disciplinary team


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_7 | Pages 9 - 9
8 May 2024
Widnall J Tonge X Jackson G Platt S
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Background. Venous Thrombo-Embolism is a recognized complication of lower limb immobilization. In the neuropathic patient total contact casting (TCC) is used in the management of acute charcot neuroathropathy and/or to off-load neuropathic ulcers, frequently for long time periods. To our knowledge there is no literature stating the prevalence of VTE in patients undergoing TCC. We perceive that neuropathic patients with active charcot have other risk factors for VTE which would predispose them to this condition and would mandate the use of prophylaxis. We report a retrospective case series assessing the prevalence of VTE in the patients being treated with TCCs. Methods. Patients undergoing TCC between 2006 and 2018 were identified using plaster room records. These patients subsequently had clinical letters and radiological reports assessed for details around the TCC episode, past medical history and any VTE events. Results. There were 143 TCC episodes in 104 patients. Average age at cast application was 55 years. Time in cast averaged 45 days (range 5 days – 8 months, median 35 days). 3 out of 4 patients had neuropathy as a consequence of diabetes. One TCC related VTE (0.7% of casting episodes) was documented. This was a proximal DVT confirmed on USS 9 days following cast removal. No patient received VTE prophylaxis while in TCC. Conclusion. Despite these complex patients having a multitude of co-morbidities the prevalence of VTE in the TCC setting remains similar to that of the general population. This may be due to the fact that TCCs permit weight bearing. This case series suggests that, while all patients should be individually VTE risk assessed as for any lower limb immobilization, chemical thromboprophylaxis is not routinely indicated in the context of TCCs


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 450 - 459
1 May 2024
Clement ND Galloway S Baron J Smith K Weir DJ Deehan DJ

Aims

The aim was to assess whether robotic-assisted total knee arthroplasty (rTKA) had greater knee-specific outcomes, improved fulfilment of expectations, health-related quality of life (HRQoL), and patient satisfaction when compared with manual TKA (mTKA).

Methods

A randomized controlled trial was undertaken (May 2019 to December 2021), and patients were allocated to either mTKA or rTKA. A total of 100 patients were randomized, 50 to each group, of whom 43 rTKA and 38 mTKA patients were available for review at 12 months following surgery. There were no statistically significant preoperative differences between the groups. The minimal clinically important difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was defined as 7.5 points.


Bone & Joint Open
Vol. 5, Issue 5 | Pages 374 - 384
1 May 2024
Bensa A Sangiorgio A Deabate L Illuminati A Pompa B Filardo G

Aims

Robotic-assisted unicompartmental knee arthroplasty (R-UKA) has been proposed as an approach to improve the results of the conventional manual UKA (C-UKA). The aim of this meta-analysis was to analyze the studies comparing R-UKA and C-UKA in terms of clinical outcomes, radiological results, operating time, complications, and revisions.

Methods

The literature search was conducted on three databases (PubMed, Cochrane, and Web of Science) on 20 February 2024 according to the guidelines for Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Inclusion criteria were comparative studies, written in the English language, with no time limitations, on the comparison of R-UKA and C-UKA. The quality of each article was assessed using the Downs and Black Checklist for Measuring Quality.


Bone & Joint 360
Vol. 13, Issue 2 | Pages 44 - 46
1 Apr 2024

The April 2024 Research Roundup360 looks at: Prevalence and characteristics of benign cartilaginous tumours of the shoulder joint; Is total-body MRI useful as a screening tool to rule out malignant progression in patients with multiple osteochondromas?; Effects of vancomycin and tobramycin on compressive and tensile strengths of antibiotic bone cement: a biomechanical study; Biomarkers for early detection of Charcot arthropathy; Strong association between growth hormone therapy and proximal tibial physeal avulsion fractures in children and adolescents; UK pregnancy in orthopaedics (UK-POP): a cross-sectional study of UK female trauma and orthopaedic surgeons and their experiences of pregnancy; Does preoperative weight loss change the risk of adverse outcomes in total knee arthroplasty by initial BMI classification?.


Bone & Joint 360
Vol. 13, Issue 2 | Pages 23 - 26
1 Apr 2024

The April 2024 Foot & Ankle Roundup360 looks at: Safety of arthroscopy combined with radial extracorporeal shockwave therapy for osteochondritis of the talus; Bipolar allograft transplantation of the ankle; Identifying risk factors for osteonecrosis after talar fracture; Balancing act: immediate versus delayed weightbearing in ankle fracture recovery; Levelling the field: proximal supination osteotomy’s efficacy in severe and super-severe hallux valgus; Restoring balance: how adjusting the tibiotalar joint line influences movement after ankle surgery.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 184 - 201
7 Mar 2024
Achten J Marques EMR Pinedo-Villanueva R Whitehouse MR Eardley WGP Costa ML Kearney RS Keene DJ Griffin XL

Aims

Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care.

Methods

This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment.


The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 51 - 58
1 Mar 2024
Jenkinson MRJ Meek DRM Tate R Brady A MacMillan S Grant H Currie S

Aims

Elevated blood cobalt levels secondary to metal-on-metal (MoM) hip arthroplasties are a suggested risk factor for developing cardiovascular complications including cardiomyopathy. Clinical studies assessing patients with MoM hips using left ventricular ejection fraction (LVEF) have found conflicting evidence of cobalt-induced cardiomyopathy. Global longitudinal strain (GLS) is an echocardiography measurement known to be more sensitive than LVEF when diagnosing early cardiomyopathies. The extent of cardiovascular injury, as measured by GLS, in patients with elevated blood cobalt levels has not previously been examined.

Methods

A total of 16 patients with documented blood cobalt ion levels above 13 µg/l (13 ppb, 221 nmol/l) were identified from a regional arthroplasty database. They were matched with eight patients awaiting hip arthroplasty. All patients underwent echocardiography, including GLS, investigating potential signs of cardiomyopathy.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 166 - 173
1 Feb 2024
Scott CEH Yapp LZ MacDonald DJ Howie CR Clement ND

Aims

The primary aim was to assess change in health-related quality of life (HRQoL) of patients as they waited from six to 12 months for a total hip (THA) or total or partial knee arthroplasty (KA). Secondary aims were to assess change in joint-specific function, mental health, quality of sleep, number living in a state worse than death (WTD), wellbeing, and patient satisfaction with their healthcare.

Methods

This prospective study included 142 patients awaiting a THA (mean age 66.7 years (SD 11.4); 71 female) and 214 patients awaiting KA (mean age 69.7 years (SD 8.7); 117 female). Patients completed questionnaires (EuroQol five-dimension health questionnaire (EQ-5D), Oxford Hip and Knee Scores (OHS/OKS), Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Score (HADS), University of California, Los Angeles Activity Scale, wellbeing assessment, and satisfaction with their healthcare) at six and 12 months while awaiting surgery.