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The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 540 - 547
1 Jun 2024
Nandra RS Elnahal WA Mayne A Brash L McBryde CW Treacy RBC

Aims

The Birmingham Hip Resurfacing (BHR) was introduced in 1997 to address the needs of young active patients using a historically proven large-diameter metal-on-metal (MoM) bearing. A single designer surgeon’s consecutive series of 130 patients (144 hips) was previously reported at five and ten years, reporting three and ten failures, respectively. The aim of this study was to extend the follow-up of this original cohort at 25 years.

Methods

The study extends the reporting on the first consecutive 144 resurfacing procedures in 130 patients for all indications. All operations were undertaken between August 1997 and May 1998. The mean age at operation was 52.1 years (SD 9.93; 17 to 76), and included 37 female patients (28.5%). Failure was defined as revision of either component for any reason. Kaplan-Meier survival analysis was performed. Routine follow-up with serum metal ion levels, radiographs, and Oxford Hip Scores (OHSs) was undertaken.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 227 - 231
1 Mar 2024
Todd NV Casey A Birch NC

The diagnostic sub-categorization of cauda equina syndrome (CES) is used to aid communication between doctors and other healthcare professionals. It is also used to determine the need for, and urgency of, MRI and surgery in these patients. A recent paper by Hoeritzauer et al (2023) in this journal examined the interobserver reliability of the widely accepted subcategories in 100 patients with cauda equina syndrome. They found that there is no useful interobserver agreement for the subcategories, even for experienced spinal surgeons. This observation is supported by the largest prospective study of the treatment of cauda equina syndrome in the UK by Woodfield et al (2023). If the accepted subcategories are unreliable, they cannot be used in the way that they are currently, and they should be revised or abandoned. This paper presents a reassessment of the diagnostic and prognostic subcategories of cauda equina syndrome in the light of this evidence, with a suggested cure based on a more inclusive synthesis of symptoms, signs, bladder ultrasound scan results, and pre-intervention urinary catheterization. Cite this article: Bone Joint J 2024;106-B(3):227–231


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1123 - 1130
1 Oct 2023
Donnan M Anderson N Hoq M Donnan L

Aims. The aim of this study was to investigate the agreement in interpretation of the quality of the paediatric hip ultrasound examination, the reliability of geometric and morphological assessment, and the relationship between these measurements. Methods. Four investigators evaluated 60 hip ultrasounds and assessed their quality based the standard plane of Graf et al. They measured geometric parameters, described the morphology of the hip, and assigned the Graf grade of dysplasia. They analyzed one self-selected image and one randomly selected image from the ultrasound series, and repeated the process four weeks later. The intra- and interobserver agreement, and correlations between various parameters were analyzed. Results. In the assessment of quality, there a was moderate to substantial intraobserver agreement for each element investigated, but interobserver agreement was poor. Morphological features showed weak to moderate agreement across all parameters but improved to significant when responses were reduced. The geometric measurements showed nearly perfect agreement, and the relationship between them and the morphological features showed a dose response across all parameters with moderate to substantial correlations. There were strong correlations between geometric measurements. The Graf classification showed a fair to moderate interobserver agreement, and moderate to substantial intraobserver agreement. Conclusion. This investigation into the reliability of the interpretation of hip ultrasound scans identified the difficulties in defining what is a high-quality ultrasound. We confirmed that geometric measurements are reliably interpreted and may be useful as a further measurement of quality. Morphological features are generally poorly interpreted, but a simpler binary classification considerably improves agreement. As there is a clear dose response relationship between geometric and morphological measurements, the importance of morphology in the diagnosis of hip dysplasia should be questioned. Cite this article: Bone Joint J 2023;105-B(10):1123–1130


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 946 - 952
1 Sep 2023
Dhawan R Young DA Van Eemeren A Shimmin A

Aims

The Birmingham Hip Resurfacing (BHR) arthroplasty has been used as a surgical treatment of coxarthrosis since 1997. We present 20-year results of 234 consecutive BHRs performed in our unit.

Methods

Between 1999 and 2001, there were 217 patients: 142 males (65.4%), mean age 52 years (18 to 68) who had 234 implants (17 bilateral). They had patient-reported outcome measures collected, imaging (radiograph and ultrasound), and serum metal ion assessment. Survivorship analysis was performed using Kaplan-Meier estimates. Revision for any cause was considered as an endpoint for the analysis.


The Bone & Joint Journal
Vol. 105-B, Issue 5 | Pages 487 - 495
1 May 2023
Boktor J Wong F Joseph VM Alshahwani A Banerjee P Morris K Lewis PM Ahuja S

Aims. The early diagnosis of cauda equina syndrome (CES) is crucial for a favourable outcome. Several studies have reported the use of an ultrasound scan of the bladder as an adjunct to assess the minimum post-void residual volume of urine (mPVR). However, variable mPVR values have been proposed as a threshold without consensus on a value for predicting CES among patients with relevant symptoms and signs. The aim of this study was to perform a meta-analysis and systematic review of the published evidence to identify a threshold mPVR value which would provide the highest diagnostic accuracy in patients in whom the diagnosis of CES is suspected. Methods. The search strategy used electronic databases (PubMed, Medline, EMBASE, and AMED) for publications between January 1996 and November 2021. All studies that reported mPVR in patients in whom the diagnosis of CES was suspected, followed by MRI, were included. Results. A total of 2,115 studies were retrieved from the search. Seven fulfilled the inclusion criteria. These included 1,083 patients, with data available from 734 being available for meta-analysis. In 125 patients, CES was confirmed by MRI. The threshold value of mPVR reported in each study varied and could be categorized into 100 ml, 200 ml, 300 ml, and 500 ml. From the meta-analysis, 200 ml had the highest diagnostic accuracy, with 82% sensitivity (95% confidence interval (CI) 0.72 to 0.90) and 65% specificity (95% CI 0.70 to 0.90). When compared using summative receiver operating characteristic curves, mPVR of 200 ml was superior to other values in predicting the radiological confirmation of CES. Conclusion. mPVR is a useful tool when assessing patients in whom the diagnosis of CES is suspected. Compared with other values a mPVR of 200 ml had superior sensitivity, specificity, and positive and negative predictive values. In a patient with a suggestive history and clinical findings, a mPVR of > 200 ml should further raise the suspicion of CES. Caution is recommended when considering the mPVR in isolation and using it as an ‘exclusion tool’, and it should only be used as an adjunct to a full clinical assessment. Cite this article: Bone Joint J 2023;105-B(5):487–495


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 227 - 229
1 Mar 2023
Theologis T Brady MA Hartshorn S Faust SN Offiah AC

Acute bone and joint infections in children are serious, and misdiagnosis can threaten limb and life. Most young children who present acutely with pain, limping, and/or loss of function have transient synovitis, which will resolve spontaneously within a few days. A minority will have a bone or joint infection. Clinicians are faced with a diagnostic challenge: children with transient synovitis can safely be sent home, but children with bone and joint infection require urgent treatment to avoid complications. Clinicians often respond to this challenge by using a series of rudimentary decision support tools, based on clinical, haematological, and biochemical parameters, to differentiate childhood osteoarticular infection from other diagnoses. However, these tools were developed without methodological expertise in diagnostic accuracy and do not consider the importance of imaging (ultrasound scan and MRI). There is wide variation in clinical practice with regard to the indications, choice, sequence, and timing of imaging. This variation is most likely due to the lack of evidence concerning the role of imaging in acute bone and joint infection in children. We describe the first steps of a large UK multicentre study, funded by the National Institute for Health Research, which seeks to integrate definitively the role of imaging into a decision support tool, developed with the assistance of individuals with expertise in the development of clinical prediction tools.

Cite this article: Bone Joint J 2023;105-B(3):227–229.


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 209 - 214
1 Feb 2023
Aarvold A Perry DC Mavrotas J Theologis T Katchburian M

Aims. A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children’s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening. Methods. A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group. Results. A total of 60 statements were graded by 128 clinicians in the first round and 132 in the second round. Consensus was reached on 30 out of 60 statements in the first round and an additional 12 in the seond. This was summarized in a consensus statement and distilled into a flowchart to guide clinical practice. Conclusion. We identified agreement in an area of medicine that has a long history of controversy and varied practice. None of the areas of consensus are based on high-quality evidence. This document is thus a framework to guide clinical practice and on which high-quality clinical trials can be developed. Cite this article: Bone Joint J 2023;105-B(2):209–214


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 452 - 463
1 Apr 2022
Elcock KL Carter TH Yapp LZ MacDonald DJ Howie CR Stoddart A Berg G Clement ND Scott CEH

Aims

Access to total knee arthroplasty (TKA) is sometimes restricted for patients with severe obesity (BMI ≥ 40 kg/m2). This study compares the cost per quality-adjusted life year (QALY) associated with TKA in patients with a BMI above and below 40 kg/m2 to examine whether this is supported.

Methods

This single-centre study compared 169 consecutive patients with severe obesity (BMI ≥ 40 kg/m2) (mean age 65.2 years (40 to 87); mean BMI 44.2 kg/m2 (40 to 66); 129/169 female) undergoing unilateral TKA to a propensity score matched (age, sex, preoperative Oxford Knee Score (OKS)) cohort with a BMI < 40 kg/m2 in a 1:1 ratio. Demographic data, comorbidities, and complications to one year were recorded. Preoperative and one-year patient-reported outcome measures (PROMs) were completed: EuroQol five-dimension three-level questionnaire (EQ-5D-3L), OKS, pain, and satisfaction. Using national life expectancy data with obesity correction and the 2020 NHS National Tariff, QALYs (discounted at 3.5%), and direct medical costs accrued over a patient’s lifetime, were calculated. Probabilistic sensitivity analysis (PSA) was used to model variation in cost/QALY for each cohort across 1,000 simulations.


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 91 - 96
1 Jan 2022
Modi A Haque A Deore V Singh HP Pandey R

Aims

Long-term outcomes following the use of human dermal allografts in the treatment of symptomatic irreparable rotator cuff tears are not known. The aim of this study was to evaluate these outcomes, and to investigate whether this would be a good form of treatment in young patients in whom a reverse shoulder arthroplasty should ideally be avoided.

Methods

This prospective study included 47 shoulders in 45 patients who underwent an open reconstruction of the rotator cuff using an interposition GraftJacket allograft to bridge irreparable cuff tears, between January 2007 and November 2011. The Oxford Shoulder Score (OSS), pain score, and range of motion (ROM) were recorded preoperatively and at one year and a mean of 9.1 years (7.0 to 12.5) postoperatively.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 644 - 649
1 Apr 2021
Alsousou J Oragu E Martin A Strickland L Newman S Kendrick B Taylor A Glyn-Jones S

Aims

The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA).

Methods

A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1535 - 1541
1 Nov 2020
Yassin M Myatt R Thomas W Gupta V Hoque T Mahadevan D

Aims. Functional rehabilitation has become an increasingly popular treatment for Achilles tendon rupture (ATR), providing comparably low re-rupture rates to surgery, while avoiding risks of surgical complications. Limited evidence exists on whether gap size should affect patient selection for this treatment option. The aim of this study was to assess if size of gap between ruptured tendon ends affects patient-reported outcome following ATR treated with functional rehabilitation. Methods. Analysis of prospectively collected data on all 131 patients diagnosed with ATR at Royal Berkshire Hospital, UK, from August 2016 to January 2019 and managed non-operatively was performed. Diagnosis was confirmed on all patients by dynamic ultrasound scanning and gap size measured with ankle in full plantarflexion. Functional rehabilitation using an established protocol was the preferred treatment. All non-operatively treated patients with completed Achilles Tendon Rupture Scores (ATRS) at a minimum of 12 months following injury were included. Results. In all, 82 patients with completed ATRS were included in the analysis. Their mean age was 51 years (standard deviation (SD) 14). The mean ATRS was 76 (SD 19) at a mean follow-up of 20 months (SD 11) following injury. Gap inversely affected ATRS with a Pearson’s correlation of -0.30 (p = 0.008). Mean ATRS was lower with gaps > 5 mm compared with ≤ 5 mm (73 (SD 21) vs 82 (SD 16); p = 0.031). Mean ATRS was lowest (70 (SD 23)) with gaps > 10 mm, with significant differences in perceived strength and pain. The overall re-rupture rate was two out of 131 (1.5%). Conclusion. Increasing gap size predicts lower patient-reported outcome, as measured by ATRS. Tendon gap > 5 mm may be a useful predictor in physically demanding individuals, and tendon gap > 10 mm for those with low physical demand. Further studies that control for gap size when comparing non-operative and operative treatment are required to assess if these patients may benefit from surgery, particularly when balanced against the surgical risks. Cite this article: Bone Joint J 2020;102-B(11):1535–1541


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1331 - 1340
3 Oct 2020
Attard V Li CY Self A Mann DA Borthwick LA O’Connor P Deehan DJ Kalson NS

Aims

Stiffness is a common complication after total knee arthroplasty (TKA). Pathogenesis is not understood, treatment options are limited, and diagnosis is challenging. The aim of this study was to investigate if MRI can be used to visualize intra-articular scarring in patients with stiff, painful knee arthroplasties.

Methods

Well-functioning primary TKAs (n = 11), failed non-fibrotic TKAs (n = 5), and patients with a clinical diagnosis of fibrosis1 (n = 8) underwent an MRI scan with advanced metal suppression (Slice Encoding for Metal Artefact Correction, SEMAC) with gadolinium contrast. Fibrotic tissue (low intensity on T1 and T2, low-moderate post-contrast enhancement) was quantified (presence and tissue thickness) in six compartments: supra/infrapatella, medial/lateral gutters, and posterior medial/lateral.


The Bone & Joint Journal
Vol. 102-B, Issue 6 | Pages 677 - 682
1 Jun 2020
Katzouraki G Zubairi AJ Hershkovich O Grevitt MP

Aims. Diagnosis of cauda equina syndrome (CES) remains difficult; clinical assessment has low accuracy in reliably predicting MRI compression of the cauda equina (CE). This prospective study tests the usefulness of ultrasound bladder scans as an adjunct for diagnosing CES. Methods. A total of 260 patients with suspected CES were referred to a tertiary spinal unit over a 16-month period. All were assessed by Board-eligible spinal surgeons and had transabdominal ultrasound bladder scans for pre- and post-voiding residual (PVR) volume measurements before lumbosacral MRI. Results. The study confirms the low predictive value of ‘red flag’ symptoms and signs. Of note ‘bilateral sciatica’ had a sensitivity of 32.4%, and a positive predictive value (PPV) of only 17.2%, and negative predictive value (NPV) 88.3%. Use of a PVR volume of ≥ 200 ml was a demonstrably more accurate test for predicting cauda equina compression on subsequent MRI (p < 0.001). The PVR sensitivity was 94.1%, specificity 66.8%, PPV 29.9% and NPV 98.7%. The PVR allowed risk-stratification with 13% patients deemed ‘low-risk’ of CES. They had non-urgent MRI scans. None of the latter scans showed any cauda equina compression (p < 0.006) or individuals developed subsequent CES in the intervening period. There were considerable cost-savings associated with the above strategy. Conclusion. This is the largest reported prospective evaluation of suspected CES. Use of the PVR volume ≥ 200 ml was considerably more accurate in predicting CES. It is a useful adjunct to conventional clinical assessment and allows risk-stratification in managing suspected CES. If adopted widely it is less likely incomplete CES would be missed. Cite this article: Bone Joint J 2020;102-B(6):677–682


The Bone & Joint Journal
Vol. 102-B, Issue 4 | Pages 495 - 500
1 Apr 2020
Milligan DJ Cosgrove AP

Aims. To monitor the performance of services for developmental dysplasia of the hip (DDH) in Northern Ireland and identify potential improvements to enhance quality of service and plan for the future. Methods. This was a prospective observational study, involving all infants treated for DDH between 2011 and 2017. Children underwent clinical assessment and radiological investigation as per the regional surveillance policy. The regional radiology data was interrogated to quantify the use of ultrasound and ionizing radiation for this population. Results. Evidence-based changes were made to the Northern Ireland screening programme, including an increase in ultrasound scanning capacity and expansion of nurse-led screening clinics. The number of infant hip ultrasound scans increased from 4,788 in 2011, to approximately 7,000 in 2013 and subsequent years. The number of hip radiographs on infants of less than one year of age fell from 7,381 to 2,208 per year. There was a modest increase in the treatment rate from 10.9 to 14.3 per 1,000 live births but there was a significant reduction in the number of closed hip reductions. The incidence of infants diagnosed with DDH after one year of age was 0.30 per 1,000 live births over the entire period. Conclusion. Improving compliance with the regional infant hip screening protocols led to reduction in operative procedures and reduced the number of pelvic radiographs of infants. We conclude that performance monitoring of screening programmes for DDH is essential to provide a quality service. Cite this article: Bone Joint J 2020;102-B(4):495–500


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 132 - 136
1 Jan 2020
Hommel H Becker R Fennema P Kopf S

Aims

We report the natural course of Baker’s cysts following total knee arthroplasty (TKA) at short- and mid-term follow-up.

Methods

In this prospective case series, 105 TKA patients were included. All patients who received surgery had a diagnosis of primary osteoarthritis and had preoperatively presented with a Baker’s cyst. Sonography and MRI were performed to evaluate the existence and the gross size of the cyst before TKA, and sonography was repeated at a mean follow-up time of 1.0 years (0.8 to 1.3; short-term) and 4.9 years (4.0 to 5.6; mid-term) after TKA. Symptoms potentially attributable to the Baker’s cyst were recorded at each assessment.


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 860 - 866
1 Jul 2019
Nicholson JA Searle HKC MacDonald D McBirnie J

Aims

The aim of this study was to investigate the influence of age on the cost-effectiveness of arthroscopic rotator cuff repair.

Patients and Methods

A total of 112 patients were prospectively monitored for two years after arthroscopic rotator cuff repair using the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH), the Oxford Shoulder Score (OSS), and the EuroQol five-dimension questionnaire (EQ-5D). Complications and use of healthcare resources were recorded. The incremental cost-effectiveness ratio (ICER) was used to express the cost per quality-adjusted life-year (QALY). Propensity score-matching was used to compare those aged below and above 65 years of age. Satisfaction was determined using the Net Promoter Score (NPS). Linear regression was used to identify variables that influenced the outcome at two years postoperatively.


The Bone & Joint Journal
Vol. 101-B, Issue 6 | Pages 635 - 638
1 Jun 2019
Marson BA Hunter JB Price KR

Aims. The aim of this study was to review the value of accepting referrals for children with ‘clicky hips’ in a selective screening programme for hip dysplasia. Patients and Methods. A single-centre prospective database of all referrals to the hip clinic was examined to identify indication for referrals, diagnosis, and treatment. All patients referred received a standardized ultrasound scan and clinical examination by an orthopaedic consultant. Results. There were 5716 children referred to the orthopaedic hip clinic between 1 June 2014 and 26 September 2018. In all, 1754 children (30.1%) were referred due to ‘clicky hip’ with no additional risk factors or indications for ultrasound scan. A total of 123 children (7.1%) referred with ‘clicky hip’ and no additional risk factors or examination findings had an abnormal initial hip ultrasound, including 16 children (0.9%) with dysplastic hips. Of the 141 children who required treatment in a Pavlik harness during the study period, 23 (16%) had been referred with a ‘clicky hip’ and no additional risk factors or examination findings, including six children with Graf 3 or 4 hips. Conclusion. There is significant value in reviewing children with an isolated ‘clicky hip’. Many children who require treatment are referred to the orthopaedic service as ‘clicky hip’ with no additional risk factors. In a pragmatic pathway with a diverse population of clinicians performing baby checks, ‘clicky hip’ is an important indication for referral and should not be discarded. Cite this article: Bone Joint J 2019;101-B:635–638


The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 552 - 558
1 May 2019
Clark D Stevens JM Tortonese D Whitehouse MR Simpson D Eldridge J

Aims

The aim of this study was to determine and compare the congruency of the articular surface contact area of the patellofemoral joint (PFJ) during both active and passive movement of the knee with the use of an MRI mapping technique in both the stable and unstable PFJ.

Patients and Methods

A prospective case-control MRI imaging study of patients with a history of PFJ instability and a control group of volunteers without knee symptoms was performed. The PFJs were imaged with the use of an MRI scan during both passive and active movement from 0° through to 40° of flexion. The congruency through measurement of the contact surface area was mapped in 5-mm intervals on axial slices. In all, 40 patients were studied. The case group included 31 patients with symptomatic patellofemoral instability and the control group of nine asymptomatic volunteers. The ages were well matched between the case and control groups. The mean age was 25 years (16 to 42; sd 6.9) in the case group and 26 years (19 to 32; sd 5.1) in the control group. There were 19 female and 12 male patients in the case group.


The Bone & Joint Journal
Vol. 101-B, Issue 3 | Pages 281 - 287
1 Mar 2019
Broadhurst C Rhodes AML Harper P Perry DC Clarke NMP Aarvold A

Aims

The aim of this study was to establish the incidence of developmental dysplasia of the hip (DDH) diagnosed after one-year of age in England, stratified by age, gender, year, and region of diagnosis.

Patients and Methods

A descriptive observational study was performed by linking primary and secondary care information from two independent national databases of routinely collected data: the United Kingdom Clinical Practice Research Datalink and Hospital Episode Statistics. The study examined all children from 1 January 1990 to 1 January 2016 who had a new first diagnostic code for DDH aged between one and eight years old.


The Bone & Joint Journal
Vol. 101-B, Issue 1 | Pages 24 - 33
1 Jan 2019
Kayani B Konan S Tahmassebi J Rowan FE Haddad FS

Aims

The objectives of this study were to compare postoperative pain, analgesia requirements, inpatient functional rehabilitation, time to hospital discharge, and complications in patients undergoing conventional jig-based unicompartmental knee arthroplasty (UKA) versus robotic-arm assisted UKA.

Patients and Methods

This prospective cohort study included 146 patients with symptomatic medial compartment knee osteoarthritis undergoing primary UKA performed by a single surgeon. This included 73 consecutive patients undergoing conventional jig-based mobile bearing UKA, followed by 73 consecutive patients receiving robotic-arm assisted fixed bearing UKA. All surgical procedures were performed using the standard medial parapatellar approach for UKA, and all patients underwent the same postoperative rehabilitation programme. Postoperative pain scores on the numerical rating scale and opiate analgesia consumption were recorded until discharge. Time to attainment of predefined functional rehabilitation outcomes, hospital discharge, and postoperative complications were recorded by independent observers.