The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures. Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics.Aims
Methods
The aim of this study was to develop and evaluate machine-learning-based computerized adaptive tests (CATs) for the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Oxford Shoulder Score (OSS), and the Oxford Elbow Score (OES) and its subscales. We developed CAT algorithms for the OHS, OKS, OSS, overall OES, and each of the OES subscales, using responses to the full-length questionnaires and a machine-learning technique called regression tree learning. The algorithms were evaluated through a series of simulation studies, in which they aimed to predict respondents’ full-length questionnaire scores from only a selection of their item responses. In each case, the total number of items used by the CAT algorithm was recorded and CAT scores were compared to full-length questionnaire scores by mean, SD, score distribution plots, Pearson’s correlation coefficient, intraclass correlation (ICC), and the Bland-Altman method. Differences between CAT scores and full-length questionnaire scores were contextualized through comparison to the instruments’ minimal clinically important difference (MCID).Aims
Methods
This article reviews four commonly used approaches to assess patient responsiveness to a treatment or therapy [Return To Normal (RTN), Minimal Important Difference (MID), Minimal Clinically Important Difference (MCID), OMERACT-OARSI (OO)], and demonstrates how each of the methods can be formulated in a multi-level modelling (MLM) framework. Data from the Arthroplasty Pain Experience (APEX) cohort study was used. Patients undergoing total hip and knee replacement completed the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire prior to surgery and then at 3, 6 and 12 months after surgery. We compare baseline scores, change scores, and proportion of individuals defined as “responders” using traditional and multi-level model (MLM) approaches to patient responsiveness.Background
Methods
The appropriate management for patients with a degenerative tear
of the rotator cuff remains controversial, but operative treatment,
particularly arthroscopic surgery, is increasingly being used. Our
aim in this paper was to compare the effectiveness of arthroscopic
with open repair of the rotator cuff. A total of 273 patients were recruited to a randomised comparison
trial (136 to arthroscopic surgery and 137 to open surgery) from
19 teaching and general hospitals in the United Kingdom. The surgeons
used their usual preferred method of repair. The Oxford Shoulder
Score (OSS), two years post-operatively, was the primary outcome
measure. Imaging of the shoulder was performed at one year after
surgery. The trial is registered with Current Controlled Trials,
ISRCTN97804283.Aims
Patients and Methods
The objective of this study was to explore dimensionality of
the Oxford Hip Score (OHS) and examine whether self-reported pain
and functioning can be distinguished in the form of subscales. This was a secondary data analysis of the UK NHS hospital episode
statistics/patient-reported outcome measures dataset containing
pre-operative OHS scores on 97 487 patients who were undergoing
hip replacement surgery. Objective
Methods
This protocol describes a pragmatic multicentre
randomised controlled trial (RCT) to assess the clinical and cost
effectiveness of arthroscopic and open surgery in the management
of rotator cuff tears. This trial began in 2007 and was modified
in 2010, with the removal of a non-operative arm due to high rates
of early crossover to surgery. Cite this article:
The primary aim of this study was to develop
a patient-reported Activity &
Participation Questionnaire (the
OKS-APQ) to supplement the Oxford knee score, in order to assess
higher levels of activity and participation. The generation of items
for the questionnaire involved interviews with 26 patients. Psychometric
analysis (exploratory and confirmatory factor analysis and Rasch
analysis) guided the reduction of items and the generation of a
scale within a prospective study of 122 relatively young patients
(mean age 61.5 years (42 to 71)) prior to knee replacement. A total
of 99, completed pre-operative and six month post-operative assessments
(new items, OKS, Short-Form 36 and American Knee Society Score). The eight-item OKS-APQ scale is unidimensional, reliable (Cronbach’s
alpha 0.85; intraclass correlation coefficient (ICC) 0.79; or 0.92
when one outlier was excluded), valid (r >
0.5 with related scales)
and responsive (effect size 4.16). We recommend that it is used with the OKS with adults of all
ages when further detail regarding the levels of activity and participation
of a patient is required. Cite this article:
Evaluation of outcomes and satisfaction following hallux valgus (HV) surgery is usually retrospective and rarely uses patient-reported outcome measures (PROMs). Prospective Cohort Study. Postal evaluation survey of patients who had provided pre-operative PROMs data.Background
Design
The Manchester–Oxford Foot Questionnaire (MOXFQ) is a validated
16-item, patient-reported outcome measure for evaluating outcomes
of foot or ankle surgery. The original development of the instrument
identified three domains. This present study examined whether the
three domains could legitimately be summed to provide a single summary
index score. The MOXFQ and Short-Form (SF)-36 were administered to 671 patients
before surgery of the foot or ankle. Data from the three domains
of the MOXFQ (pain, walking/standing and social interaction) were
subjected to higher order factor analysis. Reliability and validity
of the summary index score was assessed.Objectives
Methods
Synthetic interbody spinal fusion devices are used to restore and maintain disc height and ensure proper vertebral alignment. These devices are often filled with autograft bone to facilitate bone bridging through the device while providing mechanical stability. Nonporous polyetheretherketone (PEEK) devices are widely used clinically for such procedures.1 Twenty-five goats underwent anterior cervical discectomy and fusion using a Background
Methods
Replacing bone lost as a consequence of trauma or disease is a major challenge in the treatment of musculoskeletal disorders. Tissue engineering strategies seek to harness the potential of stem cells to regenerate lost or damaged tissue. Bone marrow aspirate (BMA) provides a promising autologous source of skeletal stem cells (SSCs) however, previous studies have demonstrated that the concentration of SSCs required for robust tissue regeneration is below levels present in iliac crest BMA, emphasising the need for cell enrichment strategies prior to clinical application. To develop a novel strategy to enrich skeletal stem cells (SSCs) from human BMA, clinically applicable for intra-operative orthopaedic use.Background
Aims
Recent approaches have sought to harness the potential of stem cells to regenerate bone lost as a consequence of trauma or disease. Bone marrow aspirate (BMA) provides an autologous source of skeletal stem cells (SSCs) for such applications, however previous studies have demonstrated that the concentration of SSCs present in iliac crest BMA is below that required for robust bone regeneration. Here we present a novel acoustic-facilitated filtration strategy to concentrate BMA for SSCs, clinically applicable for intra-operative orthopaedic use. The aim of this study was to demonstrate the efficacy of this strategy in concentrating SSCs from iliac crest bone marrow, as well as femoral canal BMA from older patients. Iliac crest BMA (Lonza, Rockville, MD, USA) and femoral canal BMA was obtained with informed consent from older patients during total hip replacement. 5 to 40ml of BMA was processed via the acoustically-aided exclusion filtration process to obtain 2-8 fold volume reductions. SSC concentration and function was assessed by flow-cytometry, assays for fibroblastic colony-forming units (CFU-F) and multi-lineage differentiation along chondrogenic, osteogenic and adipogenic pathways examined. Seeding efficiency of enriched and unprocessed BMA (normalised to cell number) onto allograft was assessed. Iliac crest BMA from 15 patients was enriched for SSCs in a processing time of only 15 minutes. Femoral BMA from 15 patients in the elderly cohort was concentrated up to 5-fold with a corresponding enrichment of viable and functional SSCs, confirmed by flow cytometry and assays for CFU-F. Enhanced osteogenic (P<0.05) and chondrogenic (P<0.001) differentiation was observed using concentrated aspirate, as evidenced by biochemical assay and semi-quantitative histological analysis. Furthermore, enhanced cell seeding efficiency onto allograft was seen as an effect of SSC concentration per ml of aspirate (P<0.001), confirming the utility of this approach for application to bone regeneration. The ability to rapidly enrich BMA demonstrates potential for intra-operative application to enhance bone healing and offers immediate capacity for clinical application to treat many scenarios associated with local bone stock loss. Further in vivo analysis is ongoing prior to clinical tests.
Skeletal stem cells can be combined with human allograft, and impacted to produce a mechanically stable living bone composite. This strategy has been used for the treatment of femoral head avascular necrosis, and has been translated to four patients, of which three remain asymptomatic at up to three year follow-up. In one patient collapse occurred in both hips due to widely distributed and advanced AVN disease, necessitating bilateral hip arthroplasty. However this has provided the opportunity to retrieve the femoral heads and analyse human tissue engineered bone. Analysis of retrieved human tissue-engineered bone in conjunction with clinical follow-up of this translational case series.Background
Aims
The Oxford Knee Score (OKS) is a validated and widely used PROM that has been successfully used in assessing the outcome of knee arthroplasty (KA). It has been adopted as the nationally agreed outcome measure for this procedure and is now routinely collected. Increasingly, it is being used on an individual patient basis as a pre-operative measure of osteoarthritis and the need for joint replacement, despite not being validated for this use. The aim of this paper is to present evidence that challenges this new role for the OKS. We have analysed pre-operative and post-operative OKS data from 3 large cohorts all undergoing KA, totalling over 3000 patients. In addition we have correlated the OKS to patient satisfaction scores. We have validated our findings using data published from the UK NJR.Purpose
Method
The patient-reported Manchester-Oxford Foot Questionnaire (MOXFQ), with 3 dimensions (Walking/standing(W/S), Pain, Social interaction(SI)) has previously been validated in patients undergoing hallux valgus surgery. A preliminary cross-sectional evaluation of its measurement properties relating to surgery on different regions of the foot and ankle is presented here. Within 4 weeks prior to foot or ankle surgery, 671of 764 consecutive eligible patients (87.8% response rate) were assessed with the: (i) MOXFQ questionnaire, (ii) SF-36 general health survey (iii) American Orthopaedic Foot & Ankle Society (AOFAS) scales. Sample characteristics: mean age 53 years 427 (63.6%) female. Patients were booked for (main) surgery on Hallux (210, 31.3%), Lesser Toes (119, 17.7%), Mid foot (22, 3.3%), Ankle/Hind foot (311, 46.3%) and whole foot/multiple regions (9, 1.3%) MOXFQ item response rates were high (<2% missing on any one item) with responses generally well distributed across response categories. Item-total correlations within each dimension were generally above recommended levels. Internal consistency, as assessed by Cronbach's alpha, were 0.93, 0.84 and 0.71 for the W/S, Pain and SI dimensions, respectively. Within Hallux, Lesser toes and Ankle/hind foot surgical subgroups (low numbers precluded mid foot and whole/multiple region analyses), alphas for these subscales were similar. Convergent validity of MOXFQ was demonstrated by correlations between the 3 dimensions (W/S, Pain, SI) with similar dimensions of the SF-36 and relevant AOFAS scales. A priori hypotheses were generally supported. The MOXFQ demonstrates good baseline measurement properties in patients undergoing a range of foot and ankle surgery, suggesting its suitability as an outcome measure for clinical trials of foot and ankle surgery in general. The SI dimension, concerned with cosmesis and social participation has somewhat weaker properties but remains useful. Evidence for the MOXFQ's responsiveness across the range of foot and ankle surgery is yet to be assessed.
The responsiveness of the Manchester–Oxford Foot
Questionnaire (MOXFQ) was compared with foot/ankle-specific and
generic outcome measures used to assess all surgery of the foot
and ankle. We recruited 671 consecutive adult patients awaiting
foot or ankle surgery, of whom 427 (63.6%) were female, with a mean
age of 52.8 years (18 to 89). They independently completed the MOXFQ,
Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively
and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle
surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS)
scores corresponding to four foot/ankle regions. A transition item measured
perceived changes in foot/ankle problems post-surgery. Of 628 eligible
patients proceeding to surgery, 491 (78%) completed questionnaires
and 262 (42%) received clinical assessments both pre- and post-operatively. The
regions receiving surgery were: multiple/whole foot in eight (1.3%),
ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in
196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific
MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (>
0.8)
than any SF-36 domains, suggesting superior responsiveness. In analyses
that anchored change in scores and effect sizes to patients’ responses
to a transition item about their foot/ankle problems, the MOXFQ
performed well. The SF-36 and EQ-5D performed poorly. Similar analyses,
conducted within foot-region based sub-groups of patients, found
that the responsiveness of the MOXFQ was good compared with the
AOFAS. This evidence supports the MOXFQ’s suitability for assessing
all foot and ankle surgery.
We obtained pre-operative and six-month post-operative
Oxford hip (OHS) and knee scores (OKS) for 1523 patients who underwent
total hip replacement and 1784 patients who underwent total knee
replacement. They all also completed a six-month satisfaction question. Scatter plots showed no relationship between pre-operative Oxford
scores and six-month satisfaction scores. Spearman’s rank correlation
coefficients were -0.04 (95% confidence interval (CI) -0.09 to 0.01)
between OHS and satisfaction and 0.04 (95% CI -0.01 to 0.08) between
OKS and satisfaction. A receiver operating characteristic (ROC) curve
analysis was used to identify a cut-off point for the pre-operative
OHS/OKS that identifies whether or not a patient is satisfied with
surgery. We obtained an area under the ROC curve of 0.51 (95% CI
0.45 to 0.56) for hip replacement and 0.56 (95% CI 0.51 to 0.60)
for knee replacement, indicating that pre-operative Oxford scores
have no predictive accuracy in distinguishing satisfied from dissatisfied
patients. In the NHS widespread attempts are being made to use patient-reported
outcome measures (PROMs) data for the purpose of prioritising patients
for surgery. Oxford hip and knee scores have no predictive accuracy
in relation to post-operative patient satisfaction. This evidence
does not support their current use in prioritising access to care.
We have compared the outcome of hemiarthroplasty of the shoulder in three distinct diagnostic groups, using survival analysis as used by the United Kingdom national joint registers, patient-reported outcome measures (PROMs) as recommended by Darzi in the 2008 NHS review, and transition and satisfaction questions. A total of 72 hemiarthroplasties, 19 for primary osteoarthritis (OA) with an intact rotator cuff, 22 for OA with a torn rotator cuff, and 31 for rheumatoid arthritis (RA), were followed up for between three and eight years. All the patients survived, with no revisions or dislocations and no significant radiological evidence of loosening. The mean new Oxford shoulder score (minimum/worst 0, maximum/best 48) improved significantly for all groups (p <
0.001), in the OA group with an intact rotator cuff from 21.4 to 38.8 (effect size 2.9), in the OA group with a torn rotator cuff from 13.3 to 27.2 (effect size 2.1) and in the RA group from 13.7 to 28.0 (effect size 3.1). By this assessment, and for the survival analysis, there was no significant difference between the groups. However, when ratings using the patient satisfaction questions were analysed, eight (29.6%) of the RA group were ‘disappointed’, compared with one (9.1%) of the OA group with cuff intact and one (7.7%) of the OA group with cuff torn. All patients in the OA group with cuff torn indicated that they would undergo the operation again, compared to ten (90.9%) in the OA group with cuff intact and 20 (76.9%) in the RA group. The use of revision rates alone does not fully represent outcome after hemiarthroplasty of the shoulder. Data from PROMs provides more information about change in pain and the ability to undertake activities and perform tasks. The additional use of satisfaction ratings shows that both the rates of revision surgery and PROMs need careful interpretation in the context of patient expectations.
We developed a questionnaire to assess patient-reported outcome after surgery of the elbow from interviews with patients. Initially, 17 possible items with five response options were included. A prospective study of 104 patients (107 elbow operations) was carried out to analyse the underlying factor structure, dimensionality, internal and test-retest reliability, construct validity and responsiveness of the questionnaire items. This was compared with the Mayo Elbow performance score clinical scale, the Disabilities of the Arm, Shoulder and Hand questionnaire, and the Short-Form (SF-36) General Health Survey. In total, five questions were considered inappropriate, which resulted in the final 12-item questionnaire, which has been referred to as the Oxford elbow score. This comprises three unidimensional domains, ‘elbow function’, ‘pain’ and ‘social-psychological’; with each domain comprising four items with good measurement properties. This new 12-item Oxford elbow score is a valid measure of the outcome of surgery of the elbow.
The Oxford hip and knee scores have been extensively used since they were first described in 1996 and 1998. During this time, they have been modified and used for many different purposes. This paper describes how they should be used and seeks to clarify areas of confusion.
The Oxford hip score (OHS) is a patient-based instrument for assessment of outcome which is often used after total hip replacement, and the EuroQol 5D (EQ5D) is a patient-based generic questionnaire for health assessment. In an analysis of the outcome at one year of 609 revision hip replacements (RHRs), we compared the OHS and EQ5D scores, postoperative patient satisfaction and change in pain. About 25% of the operations were repeat RHRs. At one year, 57% of patients were very pleased with their operation. The correlation between preoperative and postoperative scores and change scores for the OHS and EQ5D was high. For both instruments the effect sizes were large, but the greater effect size of the OHS suggests that it is particularly sensitive to improvements after RHR. The effect scores of the OHS declined with the number of previous RHRs, while those for the EQ5D seemed less sensitive. Our results confirm the value of the OHS in assessing outcome after RHR.
We carried out a prospective study of 93 patients undergoing surgery for conditions of the rotator cuff during 1994 and 1995. They were assessed before operation and after six months, and four years, using the patient-based Oxford Shoulder Score (OSS), the SF-36 questionnaire and the Constant shoulder score. The response rates were higher for the OSS and SF-36. The correlation coefficients were high (r >
0.5) between all scores at each stage of the study. While all scores improved substantially at six months, the Constant score was reduced significantly at four years. This did not correlate with the patients’ judgement of the change in symptoms or of the success of the operation. Our study suggests that patient-based measures of pain and function can reliably assess outcomes in the medium term after surgery to the shoulder.
We have developed a 12-item questionnaire for completion by patients presenting with shoulder instability. A prospective study of 92 patients was undertaken involving two assessments, approximately six months apart, performed in an outpatient department. Each patient completed the new questionnaire and the SF36 form. An orthopaedic surgeon completed the Constant shoulder score and the Rowe assessment. The new questionnaire and the Rowe clinical score each achieved a large standardised effect size (≥0.8) and compared favourably with relevant items on the SF36. By contrast, the Constant score barely registered any effect, confirming that it may be relatively insensitive to changes in clinical status for this particular condition. The questionnaire provides a measurement of outcome for shoulder instability which is short, practical, reliable, valid and sensitive to changes of clinical importance.
We have developed a 12-item questionnaire for patients having a total knee replacement (TKR). We made a prospective study of 117 patients before operation and at follow-up six months later, asking them to complete the new questionnaire and the form SF36. Some also filled in the Stanford Health Assessment Questionnaire (HAQ). An orthopaedic surgeon completed the American Knee Society (AKS) clinical score. The single score derived from the new questionnaire had high internal consistency, and its reproducibility, examined by test-retest reliability, was found to be satisfactory. Its validity was established by obtaining significant correlations in the expected direction with the AKS scores and the relevant parts of the SF36 and HAQ. Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up. We also compared change in scores with the patients’ retrospective judgement of change in their condition. The effect size for the new questionnaire compared favourably with those for the relevant parts of the SF36. The change scores for the new knee questionnaire were significantly greater (p <
0.0001) for patients who reported the most improvement in their condition. The new questionnaire provides a measure of outcome for TKR that is short, practical, reliable, valid and sensitive to clinically important changes over time.
We developed a 12-item questionnaire for completion by patients having shoulder operations other than stabilisation. A prospective study of 111 patients was undertaken before operation and at follow-up six months later. Each patient completed the new questionnaire and the SF36 form. Some filled in the Stanford Health Assessment Questionnaire (HAQ). An orthopaedic surgeon assessed the Constant shoulder score. The single score derived from the questionnaire had a high internal consistency. Reproducibility, examined by test-retest reliability, was found to be satisfactory. The validity of the questionnaire was established by obtaining significant correlations in the expected direction with the Constant score and the relevant scales of the SF36 and the HAQ. Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up. Changes in scores were compared with the patients’ responses to postoperative questions about their condition. The standardised effect size for the new questionnaire compared favourably with that for the SF36 and the HAQ. The new questionnaire was the most efficient in distinguishing patients who said that their shoulder was much better from all other patients. The shoulder questionnaire provides a measure of outcome for shoulder operations which is short, practical, reliable, valid and sensitive to clinically important changes.
We developed a 12-item questionnaire for completion by patients having total hip replacement (THR). A prospective study of 220 patients was undertaken before operation and at follow-up six months later. Each completed the new questionnaire as well as the SF36, and some the Arthritis Impact Measurement Scales (AIMS). An orthopaedic surgeon assessed the Charnley hip score. The single score derived from the questionnaire had a high internal consistency. Reproducibility was examined by test-retest reliability and was found to be satisfactory. The validity of the questionnaire was established by obtaining significant correlation in the expected direction with the Charnley scores and relevant scales of the SF36 and the AIMS. Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at the follow-up. The standardised effect size for the new questionnaire compared favourably with that for the SF36 and the AIMS. The new questionnaire provides a measure of outcome for THR which is short, practical, reliable, valid and sensitive to clinically important changes.