We compared the clinical and radiological outcomes of using a
polyetheretherketone cage with (TiPEEK) and without a titanium coating
(PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF). We conducted a randomised clinical pilot trial of 40 patients
who were scheduled to undergo a TLIF procedure at one or two levels
between L2 and L5. The Oswestry disability index (ODI), EuroQoL-5D,
and back and leg pain were determined pre-operatively, and at three,
six, and 12 months post-operatively. Fusion rates were assessed
by thin slice CT at three months and by functional radiography at
12 months.Aims
Materials and Methods
There is little information about the optimum number of implants
to be used in the surgical treatment of idiopathic scoliosis. Retrospective
analysis of prospectively collected data from the Swedish spine
register was undertaken to discover whether more implants per operated
vertebra (implant density) leads to a better outcome in the treatment of
idiopathic scoliosis. The hypothesis was that implant density is
not associated with patient-reported outcomes, the correction of
the curve or the rate of reoperation. A total of 328 patients with idiopathic scoliosis, aged between
ten and 20 years at the time of surgery, were identified in the
Swedish spine register (Swespine) and had patient reported outcomes
including the Scoliosis Research Society 22r instrument (SRS-22r)
score, EuroQol 5 dimensions quality of life, 3 level (EQ-5D-3L)
score and a Viual Analogue Score (VAS) for back pain, at a mean
follow-up of 3.1 years and reoperation data at a mean follow-up
of 5.5 years. Implant data and the correction of the curve were
assessed from radiographs, preoperatively and a mean of 1.9 years
postoperatively. The patients were divided into tertiles based on
implant density. Data were analyzed with analysis of variance, logistic
regression or log-rank test. Some analyses were adjusted for gender,
age at the time of surgery, the flexibility of the major curve and
follow-up.Aims
Patients and Methods
The results of kinematic total knee arthroplasty (KTKA) have been reported in terms of limb and component alignment parameters but not in terms of gap laxities and differentials. In kinematic alignment (KA), balance should reflect the asymmetrical balance of the normal knee, not the classic rectangular flexion and extension gaps sought with gap-balanced mechanical axis total knee arthroplasty (MATKA). This paper aims to address the following questions: 1) what factors determine coronal joint congruence as measured on standing radiographs?; 2) is flexion gap asymmetry produced with KA?; 3) does lateral flexion gap laxity affect outcomes?; 4) is lateral flexion gap laxity associated with lateral extension gap laxity?; and 5) can consistent ligament balance be produced without releases? A total of 192 KTKAs completed by a single surgeon using a computer-assisted technique were followed for a mean of 3.5 years (2 to 5). There were 116 male patients (60%) and 76 female patients (40%) with a mean age of 65 years (48 to 88). Outcome measures included intraoperative gap laxity measurements and component positions, as well as joint angles from postoperative three-foot standing radiographs. Patient-reported outcome measures (PROMs) were analyzed in terms of alignment and balance: EuroQol (EQ)-5D visual analogue scale (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS Joint Replacement (JR), and Oxford Knee Score (OKS).Aims
Patients and Methods
Patients with an acute Achilles tendon rupture (ATR) take a long
time to heal, have a high incidence of deep vein thrombosis (DVT)
and widely variable functional outcomes. This variation in outcome
may be explained by a lack of knowledge of adverse factors, and
a subsequent shortage of appropriate interventions. A total of 111 patients (95 men, 16 women; mean age 40.3, standard
deviation 8.4) with an acute total ATR were prospectively assessed.
At one year post-operatively a uniform outcome score, Achilles Combined
Outcome Score (ACOS), was obtained by combining three validated,
independent, outcome measures: Achilles tendon Total Rupture Score,
heel-rise height test, and limb symmetry heel-rise height. Predictors
of ACOS included treatment; gender; age; smoking; body mass index;
time to surgery; physical activity level pre- and post-injury; symptoms; quality
of life and incidence of DVT. Aims
Patients and Methods
A trial-based comparison of the use of resources, costs and quality
of life outcomes of arthroscopic and open surgical management for
rotator cuff tears in the United Kingdom NHS was performed using
data from the United Kingdom Rotator Cuff Study (UKUFF) randomised
controlled trial. Using data from 273 patients, healthcare-related use of resources,
costs and quality-adjusted life years (QALYs) were estimated at
12 months and 24 months after surgery on an intention-to-treat basis
with adjustment for covariates. Uncertainty about the incremental
cost-effectiveness ratio for arthroscopic Aims
Patients and Methods
The aim of this study was to compare the incidence of aseptic
loosening after the use of a cemented acetabular component and a
Trabecular Metal (TM) acetabular component (Zimmer Inc., Warsaw,
Indiana) at acetabular revision with bone impaction grafting. A total of 42 patients were included in the study. Patients were
randomised to receive an all- polyethylene cemented acetabular component
(n = 19) or a TM component (n = 23). Radiostereometric analysis
and conventional radiographic examinations were performed regularly
up to two years post-operatively or until further revision.Aims
Patients and Methods
Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.Background
Design
We wished to assess the feasibility of a future randomised controlled
trial of parathyroid hormone (PTH) supplements to aid healing of
trochanteric fractures of the hip, by an open label prospective
feasibility and pilot study with a nested qualitative sub study.
This aimed to inform the design of a future powered study comparing
the functional recovery after trochanteric hip fracture in patients
undergoing standard care, We undertook a pilot study comparing the functional recovery
after trochanteric hip fracture in patients 60 years or older, admitted
with a trochanteric hip fracture, and potentially eligible to be
randomised to either standard care or the administration of subcutaneous
PTH for six weeks. Our desired outcomes were functional testing
and measures to assess the feasibility and acceptability of the
study.Aims
Patients and Methods
We aimed to assess the comparability of data in joint replacement
registries and identify ways of improving the comparisons between
registries and the overall monitoring of joint replacement surgery. We conducted a review of registries that are full members of
the International Society of Arthroplasty Registries with publicly
available annual reports in English. Of the six registries which
were included, we compared the reporting of: mean age, definitions
for revision and re-operation, reasons for revision, the approach
to analysing revisions, and patient-reported outcome measures (PROMs)
for primary and revision total hip arthroplasty (THA) and hip resurfacing
arthroplasty (HRA).Aims
Materials and Methods
This study compares the cost-effectiveness of
treating dorsally displaced distal radial fractures with a volar
locking plate and percutaneous fixation. It was performed from the
perspective of the National Health Service (NHS) using data from
a single-centre randomised controlled trial. In total 130 patients
(18 to 73 years of age) with a dorsally displaced distal radial
fracture were randomised to treatment with either a volar locking
plate (n = 66) or percutaneous fixation (n = 64). The methodology
was according to National Institute for Health and Care Excellence guidance
for technology appraisals. . There were no significant differences in quality of life scores
between groups at any time point in the study. Both groups returned
to baseline one year post-operatively. NHS costs for the plate group were significantly higher (p <
0.001, 95% confidence interval 497 to 930). For an additional £713,
fixation with a volar locking plate offered 0.0178 additional quality-adjusted
life years in the year after surgery. The incremental cost-effectiveness
ratio (ICER) for plate fixation relative to percutaneous fixation
at list price was £40 068. When adjusting the prices of the implants
for a 20% hospital discount, the ICER was £31 898. Patients who
underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from
the perspective of the NHS, of fixation using a volar locking plate
over percutaneous fixation for the operative treatment of a dorsally
displaced radial fracture. Cite this article:
A pragmatic multicentre randomised controlled trial (PROFHER)
was conducted in United Kingdom National Health Service (NHS) hospitals
to evaluate the clinical effectiveness and cost effectiveness of
surgery compared with non-surgical treatment for displaced fractures
of the proximal humerus involving the surgical neck in adults. A cost utility analysis from the NHS perspective was performed.
Differences between surgical and non-surgical treatment groups in
costs and quality adjusted life years (QALYs) at two years were
used to derive an estimate of the cost effectiveness of surgery
using regression methods. Aims
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
We present an economic evaluation using data
from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare
the relative cost effectiveness of percutaneous Kirschner wire (K-wire)
fixation and volar locking-plate fixation for patients with dorsally-displaced
fractures of the distal radius. The cost effectiveness analysis (cost per quality-adjusted life
year; QALY) was derived from a multi-centre, two-arm, parallel group,
assessor-blind, randomised controlled trial which took place in
18 trauma centres in the United Kingdom. Data from 460 patients
were available for analysis, which includes both a National Health
Service cost perspective including costs of surgery, implants and
healthcare resource use over a 12-month period after surgery, and
a societal perspective, which includes the cost of time off work
and the need for additional private care. There was only a small difference in QALYs gained for patients
treated with locking-plate fixation over those treated with K-wires.
At a mean additional cost of £714 (95% confidence interval 588 to
865) per patient, locking-plate fixation presented an incremental
cost effectiveness ratio (ICER) of £89 322 per QALY within the first
12 months of treatment. Sensitivity analyses were undertaken to
assess the ICER of locking-plate fixation compared with K-wires.
These were greater than £30 000. Compared with locking-plate fixation, K-wire fixation is a ‘cost
saving’ intervention, with similar health benefits. Cite this article:
Hip fracture is a common injury associated with
high mortality, long-term disability and huge socio-economic burden.
Yet there has been relatively little research into best treatment,
and evidence that has been generated has often been criticised for
its poor quality. Here, we discuss the advances made towards overcoming
these criticisms and the future directions for hip fracture research:
how co-ordinating existing national infrastructures and use of now
established clinical research networks will likely go some way towards
overcoming the practical and financial challenges of conducting
large trials. We highlight the importance of large collaborative
pragmatic trials to inform decision/policy makers and the progress
made towards reaching a consensus on a core outcome set to facilitate data
pooling for evidence synthesis and meta-analysis. These advances and future directions are a priority in order
to establish the high-quality evidence base required for this important
group of patients. Cite this article:
We evaluated clinical and radiographic outcomes of total shoulder
arthroplasty (TSA) using the second-generation Trabecular Metal
(TM) Glenoid component. The first generation component was withdrawn
in 2005 after a series of failures were reported. Between 2009 and
2012, 40 consecutive patients with unilateral TSA using the second-generation
component were enrolled in this clinical study. The mean age of
the patients was 63.8 years (40 to 75) and the mean follow-up was
38 months (24 to 42). Patients were evaluated using the Constant score (CS), the American
Shoulder and Elbow Surgeons (ASES) score and routine radiographs.Aims
Methods
We wished to compare the clinical outcome, as assessed by questionnaires
and the rate of complications, in total knee arthroplasty (TKA)
undertaken with patient-matched positioning guides (PMPGs) or conventional
instruments. A total of 180 patients (74 men, 106 women; mean age 67 years)
were included in a multicentre, adequately powered, double-blind,
randomised controlled trial. The mean follow-up was 44 months (24
to 57).Aims
Patients and Methods
