Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.Aims
Methods
To identify the responsiveness, minimal clinically important difference (MCID), minimal clinical important change (MIC), and patient-acceptable symptom state (PASS) thresholds in the 36-item Short Form Health Survey questionnaire (SF-36) (v2) for each of the eight dimensions and the total score following total knee arthroplasty (TKA). There were 3,321 patients undergoing primary TKA with preoperative and one-year postoperative SF-36 scores. At one-year patients were asked how satisfied they were and “How much did the knee arthroplasty surgery improve the quality of your life?”, which was graded as: great, moderate, little (n = 277), none (n = 98), or worse.Aims
Methods
A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods.Aims
Methods
The primary aim was to assess the patient-perceived effect of restrictions imposed due to COVID-19 on rehabilitation following total hip arthroplasty (THA) and total knee arthroplasty (TKA). Secondary aims were to assess perceived restrictions, influence on mental health, and functional outcome compared to patients undergoing surgery without restriction. During February and March 2020, 105 patients underwent THA (n = 48) or TKA (n = 57) and completed preoperative and six-month postoperative assessments. A cohort of 415 patients undergoing surgery in 2019 were used as the control. Patient demographic data, BMI, comorbidities, Oxford Hip Score (OHS) or Knee Score (OKS), and EuroQoL five-domain (EQ-5D) score were collected preoperatively and at six months postoperatively. At six months postoperatively, the 2020 patients were also asked to complete a questionnaire relating to the effect of the social restrictions on their outcome and their mental health.Aims
Methods
Complex fractures of the femur and tibia with associated severe soft tissue injury are often devastating for the individual. The aim of this study was to describe the two-year patient-reported outcomes of patients in a civilian population who sustained a complex fracture of the femur or tibia with a Mangled Extremity Severity Score (MESS) of ≥ 7, whereby the score ranges from 2 (lowest severity) to 11 (highest severity). Patients aged ≥ 16 years with a fractured femur or tibia and a MESS of ≥ 7 were extracted from the Victorian Orthopaedic Trauma Outcomes Registry (January 2007 to December 2018). Cases were grouped into surgical amputation or limb salvage. Descriptive analysis were used to examine return to work rates, three-level EuroQol five-dimension questionnaire (EQ-5D-3L), and Glasgow Outcome Scale-Extended (GOS-E) outcomes at 12 and 24 months post-injury.Aims
Methods
A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.Aims
Methods
Perthes’ disease is a condition leading to necrosis of the femoral head. It is most common in children aged four to nine years, affecting around one per 1,200 children in the UK. Management typically includes non-surgical treatment options, such as physiotherapy with/without surgical intervention. However, there is significant variation in care with no consensus on the most effective treatment option. This systematic review aims to evaluate the effectiveness of non-surgical interventions for the treatment of Perthes’ disease. Comparative studies (experimental or observational) of any non-surgical intervention compared directly with any alternative intervention (surgical, non-surgical or no intervention) were identified from: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMcare, Allied and Complementary Medicine Database (AMED), and the Physiotherapy Evidence Database (PEDro). Data were extracted on interventions compared and methodological quality. For post-intervention primary outcome of radiological scores (Stulberg and/or Mose), event rates for poor scores were calculated with significance values. Secondary outcomes included functional measures, such as range of movement, and patient-reported outcomes such as health-related quality of life.Aims
Methods
The PROximal Fracture of the Humerus Evaluation by Randomisation
(PROFHER) randomised clinical trial compared the operative and non-operative
treatment of adults with a displaced fracture of the proximal humerus
involving the surgical neck. The aim of this study was to determine
the long-term treatment effects beyond the two-year follow-up. Of the original 250 trial participants, 176 consented to extended
follow-up and were sent postal questionnaires at three, four and
five years after recruitment to the trial. The Oxford Shoulder Score
(OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent
shoulder operations and fracture data were collected. Statistical
and economic analyses, consistent with those of the main trial were
applied.Aims
Patients and 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 optimal management of intracapsular fractures of the femoral
neck in independently mobile patients remains open to debate. Successful
fixation obviates the limitations of arthroplasty for this group
of patients. However, with fixation failure rates as high as 30%,
the outcome of revision surgery to salvage total hip arthroplasty
(THA) must be considered. We carried out a systematic review to
compare the outcomes of salvage THA and primary THA for intracapsular
fractures of the femoral neck. We performed a Preferred Reporting Items for Systematic Reviews
and Meta-Analysis (PRISMA) compliant systematic review, using the
PubMed, EMBASE and Cochrane libraries databases. A meta-analysis
was performed where possible, and a narrative synthesis when a meta-analysis
was not possible.Aims
Patients and Methods
Controversy remains whether the contralateral
hip should be fixed in patients presenting with unilateral slipped capital
femoral epiphysis (SCFE). This retrospective study compares the
outcomes and cost of those patients who had prophylactic fixation
with those who did not. Between January 2000 and December 2010 a total of 50 patients
underwent unilateral fixation and 36 had prophylactic fixation of
the contralateral hip. There were 54 males and 32 females with a
mean age of 12.3 years (9 to 16). The rate of a subsequent slip
without prophylactic fixation was 46%. The risk of complications
was greater, the generic health measures (Short Form-12 physical
(p <
0.001) and mental (p = 0.004) summary scores) were worse.
Radiographic cam lesions in patients presenting with unilateral
SCFE were only seen in patients who did not have prophylactic fixation.
Furthermore, prophylactic fixation of the contralateral hip was
found to be a cost-effective procedure, with a cost per quality
adjusted life year gained of £1431 at the time of last follow-up. Prophylactic fixation of the contralateral hip is a cost-effective
operation that limits the morbidity from the complications of a
further slip, and the diminished functional outcome associated with
unilateral fixation. Cite this article:
The effects of surgical approach in total hip
replacement on health-related quality of life and long-term pain
and satisfaction are unknown. From the Swedish Hip Arthroplasty
Register, we extracted data on all patients that had received a
total hip replacement for osteoarthritis through either the posterior
or the direct lateral approach, with complete pre- and one-year
post-operative Patient Reported Outcome Measures (PROMs). A total
of 42 233 patients met the inclusion criteria and of these 4962
also had complete six-year PROM data. The posterior approach resulted in
an increased mean satisfaction score of 15 ( Cite this article:
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
The December 2013 Shoulder &
Elbow Roundup360 looks at: Platelet-rich plasma; Arthroscopic treatment of sternoclavicular joint osteoarthritis; Synchronous arthrolysis and cuff repair; Arthroscopic arthrolysis; Regional blockade in the beach chair; Recurrent instability; Avoiding iatrogenic nerve injury in elbow arthroscopy; and Complex reconstruction of total elbow revisions
There is little published information on the
health impact of frozen shoulder. The purpose of this study was
to assess the functional and health-related quality of life outcomes
following arthroscopic capsular release (ACR) for contracture of
the shoulder. Between January 2010 and January 2012 all patients
who had failed non-operative treatment including anti-inflammatory
medication, physiotherapy and glenohumeral joint injections for
contracture of the shoulder and who subsequently underwent an ACR
were enrolled in the study. A total of 100 patients were eligible;
68 underwent ACR alone and 32 had ACR with a subacromial decompression
(ASD). ACR resulted in a highly significant improvement in the range
of movement and functional outcome, as measured by the Oxford shoulder
score and EuroQol EQ-5D index. The mean cost of a quality-adjusted
life year (QALY) for an ACR and ACR with an ASD was £2563 and £3189,
respectively. ACR is thus a cost-effective procedure that can restore relatively
normal function and health-related quality of life in most patients
with a contracture of the shoulder within six months after surgery;
and the beneficial effects are not related to the duration of the
presenting symptoms. Cite this article:
The December 2012 Trauma Roundup360 looks at: more is not always better, especially when its chemotherapy; new hope for skeletal metastasis; biopsy tracts; intra-operative imaging of sarcomas; curettage with adjuvant therapy; amputation and distal tibial osteosarcoma; and diaphyseal tibial tumours.
We evaluated the long-term functional outcome in 118 patients treated for osteosarcoma or Ewing’s sarcoma in the extremities a minimum of five years after treatment. We also examined if impaired function influenced their quality of life and ability to work. The function was evaluated according to the Musculoskeletal Tumor Society (MSTS) score and the Toronto Extremity Salvage Score (TESS). Quality of life was assessed by using the Short Form-36 (SF-36). The mean age at follow-up was 31 years (15 to 57) and the mean follow-up was for 13 years (6 to 22). A total of 67 patients (57%) initially had limb-sparing surgery, but four had a secondary amputation. The median MSTS score was 70% (17% to 100%) and the median TESS was 89% (43% to 100%). The amputees had a significantly lower MSTS score than those with limb-sparing surgery (p <
0.001), but there was no difference for the TESS. Tumour localisation above knee level resulted in significantly lower MSTS scores and TESS (p = 0.003 and p = 0.02, respectively). There were no significant differences in quality of life between amputees and those with limb-sparing surgery except in physical functioning. Of the patients 11% (13) did not work or study. In multivariate analysis, amputation, tumour location above the knee and having muscular pain were associated with low physical function. We conclude that most of the bone tumour survivors managed well after adjustment to their physical limitations. A total of 105 are able to work and have an overall good quality of life.