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:
An atypical femoral fracture (AFF), with a transverse
fracture radiologically through the lateral cortex is a rare but serious
condition. In order to improve our ability to identify patients
with this condition, we retrospectively surveyed all subtrochanteric,
peri-implant and diaphyseal femoral fractures in patients aged ≥ 65
years who underwent surgical treatment at our hospital between 2004
and 2011. We describe the incidence of atypical fractures and their characteristics,
with observational data including a review of the hospital and general
practitioner records. Clinical outcomes were evaluated using the
Harris hip score (HHS) and the timed up-and-go (TUG) test. Atypical fractures only occurred in women with an incidence of
9.8 per 100 000 person-years. The incidence in those who were treated
with bisphosphonates was 79.0 per 100 000 person-years; eight of
17 fractures occurred around metal implants. There was a high incidence
of delayed union and revision surgery. A total of nine patients (ten
AFFs) were available for review at a mean follow-up of 36.5 months
(10 to 104). The clinical outcome was poor with a mean HHS of 58.9
(95% CI 47.4 to 70.4) and a mean TUG test of 25.7 s (95% CI 12.7
to 38.8). The delay in diagnosis and treatment of AFF may result from a
lack of knowledge of this condition. Cite this article:
In this randomised controlled trial, we evaluated
the role of elastic compression using ankle injury stockings (AIS)
in the management of fractures of the ankle. A total of 90 patients
with a mean age of 47 years (16 to 79) were treated within 72 hours
of presentation with a fracture of the ankle, 31 of whom were treated
operatively and 59 conservatively, were randomised to be treated
either with compression by AIS plus an Aircast boot or Tubigrip
plus an Aircast boot. Male to female ratio was 36:54. The primary
outcome measure was the functional Olerud–Molander ankle score (OMAS).
The secondary outcome measures were; the American Orthopaedic Foot
and Ankle Society score (AOFAS); the Short Form (SF)-12v2 Quality
of Life score; and the frequency of deep vein thrombosis (DVT). Compression using AIS reduced swelling of the ankle at all time
points and improved the mean OMAS score at six months to 98 (95%
confidence interval (CI) 96 to 99) compared with a mean of 67 (95%
CI 62 to 73) for the Tubigrip group (p <
0.001). The mean AOFAS
and SF-12v2 scores at six months were also significantly improved
by compression. Of 86 patients with duplex imaging at four weeks,
five (12%) of 43 in the AIS group and ten (23%) of 43 in the Tubigrip
group developed a DVT (p = 0.26). Compression improved functional outcome and quality of life following
fracture of the ankle. DVTs were frequent, but a larger study would
be needed to confirm that compression with AISs reduces the incidence
of DVT. Cite this article:
We investigated the spinopelvic morphology and
global sagittal balance of patients with a degenerative retrolisthesis
or anterolisthesis. A total of 269 consecutive patients with a degenerative
spondylolisthesis were included in this study. There were 95 men
and 174 women with a mean age of 64.3 years ( A backward slip was found in the upper lumbar levels (mostly
L2 or L3) with an almost equal gender distribution in both the R
and R+A groups. The pelvic incidence and sacral slope of the R group
were significantly lower than those of the A (both p <
0.001)
and R+A groups (both p <
0.001). The lumbar lordosis of the R+A
group was significantly greater than that of the R (p = 0.025) and
A groups (p = 0.014). The C7 plumb line of the R group was located
more posteriorly than that of the A group (p = 0.023), but was no
different from than that of the R+A group (p = 0.422). The location
of C7 plumb line did not differ between the three groups (p = 0.068).
The spinosacral angle of the R group was significantly smaller than
that of the A group (p <
0.001) and R+A group (p <
0.001). Our findings imply that there are two types of degenerative retrolisthesis:
one occurs primarily as a result of degeneration in patients with
low pelvic incidence, and the other occurs secondarily as a compensatory
mechanism in patients with an anterolisthesis and high pelvic incidence. Cite this article:
The December 2013 Foot &
Ankle Roundup360 looks at: Maisonneuve fractures in the long term; Not all gastrocnemius lengthening equal; Those pesky os fibulare; First tarsometatarsal arthrosis; Juvenile osteochondral lesions; Calcanei and infections; Clinical outcomes of Weber B ankle fractures; and rheumatologists have no impact on ankle rheumatoid arthritis.
Cartilage repair in terms of replacement, or
regeneration of damaged or diseased articular cartilage with functional tissue,
is the ‘holy grail’ of joint surgery. A wide spectrum of strategies
for cartilage repair currently exists and several of these techniques
have been reported to be associated with successful clinical outcomes
for appropriately selected indications. However, based on respective
advantages, disadvantages, and limitations, no single strategy, or
even combination of strategies, provides surgeons with viable options
for attaining successful long-term outcomes in the majority of patients.
As such, development of novel techniques and optimisation of current techniques
need to be, and are, the focus of a great deal of research from
the basic science level to clinical trials. Translational research
that bridges scientific discoveries to clinical application involves
the use of animal models in order to assess safety and efficacy
for regulatory approval for human use. This review article provides
an overview of animal models for cartilage repair. Cite this article:
The purpose of this study was to evaluate treatment
results following arthroscopic triangular fibrocartilage complex (TFCC)
debridement for recalcitrant ulnar wrist pain. According to the
treatment algorithm, 66 patients (36 men and 30 women with a mean
age of 38.1 years (15 to 67)) with recalcitrant ulnar wrist pain
were allocated to undergo ulnar shortening osteotomy (USO; n = 24),
arthroscopic TFCC repair (n = 15), arthroscopic TFCC debridement
(n = 14) or prolonged conservative treatment (n = 13). The mean
follow-up was 36.0 months (15 to 54). Significant differences in
Hand20 score at 18 months were evident between the USO group and
TFCC debridement group (p = 0.003), and between the TFCC repair
group and TFCC debridement group (p = 0.029). Within-group comparisons showed
that Hand20 score at five months or later and pain score at two
months or later were significantly decreased in the USO/TFCC repair
groups. In contrast, scores in the TFCC debridement/conservative
groups did not decrease significantly. Grip strength at 18 months
was significantly improved in the USO/TFCC repair groups, but not
in the TFCC debridement/conservative groups. TFCC debridement shows
little benefit on the clinical course of recalcitrant ulnar wrist
pain even after excluding patients with ulnocarpal abutment or TFCC
detachment from the fovea from the indications for arthroscopic
TFCC debridement. Cite this article:
The February 2013 Spine Roundup360 looks at: complications with anterior decompression and fusion; lumbar claudication and peripheral vascular disease; increasing cervical instability in rheumatoids; kyphoplasty; cervical stenosis; exercise or fusion for chronic lower back pain; lumbar disc arthroplasty and adjacent level changes; and obese disc prolapses.
This article presents an overview of mycetoma
and offers guidelines for orthopaedic surgeons who may be involved in
the care of patients with this condition. Cite this article:
The February 2014 Knee Roundup360 looks at: whether sham surgery is as good as arthroscopic meniscectomy; distraction in knee osteoarthritis; whether trans-tibial tunnel placement increases the risk of graft failure in ACL surgery; whether joint replacements prevent cardiac events; the size of the pulmonary embolism problem; tranexamic acid and knee replacement haemostasis; matching the demand for knee replacement and follow-up; predicting the length of stay after knee replacement; and popliteal artery injury in TKR.
The August 2013 Wrist &
Hand Roundup360 looks at: random group therapy is no good at treating OA of the hand; salvaging failed CMCJ arthroplasty; scaphocapitate arthrodesis for instability in manual workers; Brunelli tenodesis and scapholunate instability; night splints for Dupytren’s revisited; the smallest IM nail?; early diagnosis of CRPS?; and endoscopic carpal tunnel release?
The August 2013 Spine Roundup360 looks at: SPECT CT and facet joints; a difficult conversation: scoliosis and complications; time for a paradigm shift? complications under the microscope; minor trauma and cervical injury: a predictable phenomenon?; more costly all round: incentivising more complex operations?; minimally invasive surgery = minimal scarring; and symptomatic lumbar spine stenosis.
Although the importance of lateral femoral wall
integrity is increasingly being recognised in the treatment of intertrochanteric
fracture, little attention has been put on the development of a
secondary post-operative fracture of the lateral wall. Patients
with post-operative fractures of the lateral wall were reported
to have high rates of re-operation and complication. To date, no
predictors of post-operative lateral wall fracture have been reported.
In this study, we investigated the reliability of lateral wall thickness
as a predictor of lateral wall fracture after dynamic hip screw
(DHS) implantation. A total of 208 patients with AO/OTA 31-A1 and -A2 classified
intertrochanteric fractures who received internal fixation with
a DHS between January 2003 and May 2012 were reviewed. There were
103 men and 150 women with a mean age at operation of
78 years (33 to 94). The mean follow-up was 23 months (6 to 83).
The right side was affected in 97 patients and the left side in
111. Clinical information including age, gender, side, fracture
classification, tip–apex distance, follow-up time, lateral wall
thickness and outcome were recorded and used in the statistical
analysis. Fracture classification and lateral wall thickness significantly
contributed to post-operative lateral wall fracture (both p <
0.001). The lateral wall thickness threshold value for risk of developing
a secondary lateral wall fracture was found to be 20.5 mm. To our knowledge, this is the first study to investigate the
risk factors of post-operative lateral wall fracture in intertrochanteric
fracture. We found that lateral wall thickness was a reliable predictor
of post-operative lateral wall fracture and conclude that intertrochanteric
fractures with a lateral wall thickness <
20.5 mm should not
be treated with DHS alone. Cite this article:
Some surgeons are reluctant to perform a reverse
total shoulder arthroplasty (RTSA) on both shoulders because of concerns
regarding difficulty with activities of daily living post-operatively
as a result of limited rotation of the shoulders. Nevertheless,
we hypothesised that outcomes and patient satisfaction following
bilateral RTSA would be comparable to those following unilateral
RTSA. A single-surgeon RTSA registry was reviewed for patients who underwent
bilateral staged RTSA with a minimum follow-up of two years. A unilateral
RTSA matched control was selected for each shoulder in those patients
undergoing bilateral procedures. The Constant–Murley score (CMS), American
Shoulder and Elbow Surgeons (ASES) score, Subjective Shoulder Values
(SSV), visual analogue scale (VAS) for pain, range of movement and
strength were measured pre- and post-operatively. The mean CMS,
ASES, SSV, VAS scores, strength and active forward elevation were
significantly improved
(all p <
0.01) following each operation in those undergoing bilateral
procedures. The mean active external rotation (p = 0.63 and p =
0.19) and internal rotation (p = 0.77 and p = 0.24) were not significantly
improved. The improvement in the mean ASES score after the first
RTSA was greater than the improvement in its control group (p =
0.0039). The improvement in the mean CMS, ASES scores and active
forward elevation was significantly less after the second RTSA than
in its control group (p = 0.0244, p = 0.0183, and p = 0.0280, respectively).
Pain relief and function significantly improved after each RTSA
in those undergoing a bilateral procedure. Bilateral RTSA is thus a reasonable form of treatment for patients
with severe bilateral rotator cuff deficiency, although inferior
results may be seen after the second procedure compared with the
first. Cite this article:
Because of the contradictory body of evidence related to the
potential benefits of helical blades in trochanteric fracture fixation,
we studied the effect of bone compaction resulting from the insertion
of a proximal femoral nail anti-rotation (PFNA). We developed a subject-specific computational model of a trochanteric
fracture (31-A2 in the AO classification) with lack of medial support
and varied the bone density to account for variability in bone properties
among hip fracture patients.Objectives
Methods
The February 2013 Shoulder &
Elbow Roundup360 looks at: whether we should replace fractured shoulders; the limited evidence for shoulder fractures; cuffs and early physio; matrix proteins and cuff tears; long-term SLAP tear outcomes; suture anchors; recurrent Bankart repairs; and acromial morphology and calcific tendonitis.
We have designed a prospective study to evaluate
the usefulness of prolonged incubation of cultures from sonicated
orthopaedic implants. During the study period 124 implants from
113 patients were processed (22 osteosynthetic implants, 46 hip
prostheses, 54 knee prostheses, and two shoulder prostheses). Of
these, 70 patients had clinical infection; 32 had received antibiotics
at least seven days before removal of the implant. A total of 54 patients
had sonicated samples that produced positive cultures (including
four patients without infection). All of them were positive in the
first seven days of incubation. No differences were found regarding
previous antibiotic treatment when analysing colony counts or days
of incubation in the case of a positive result. In our experience, extending
incubation of the samples to 14 days does not add more positive
results for sonicated orthopaedic implants (hip and knee prosthesis
and osteosynthesis implants) compared with a conventional seven-day incubation
period. Cite this article:
In patients with osteoporosis there is always
a strong possibility that pedicle screws will loosen. This makes
it difficult to select the appropriate osteoporotic patient for
a spinal fusion. The purpose of this study was to determine the
correlation between bone mineral density (BMD) and the magnitude
of torque required to insert a pedicle screw. To accomplish this,
181 patients with degenerative disease of the lumbar spine were
studied prospectively. Each underwent dual-energy x-ray absorptiometry
(DEXA) and intra-operative measurement of the torque required to
insert each pedicle screw. The levels of torque generated in patients
with osteoporosis and osteopenia were significantly lower than those
achieved in normal patients. Positive correlations were observed between
BMD and T-value at the instrumented lumbar vertebrae, mean BMD and
mean T-value of the lumbar vertebrae, and mean BMD and mean T-value
of the proximal femur. The predictive torque (Nm) generated during pedicle
screw insertion was [-0.127 + 1.62 × (BMD at the corresponding lumbar
vertebrae)], as measured by linear regression analysis. The positive
correlation between BMD and the maximum torque required to insert
a pedicle screw suggests that pre-operative assessment of BMD may
be useful in determining the ultimate strength of fixation of a
device, as well as the number of levels that need to be fixed with
pedicle screws in patients who are suspected of having osteoporosis.
The June 2013 Children’s orthopaedics Roundup360 looks at: whether reaching a diagnosis is more difficult than previously thought; adolescent and paediatric DDH; the A-frame orthosis and Legg-Calvé-Perthes’ disease; failure of hip surgery in patients with cerebral palsy; adolescent rotator cuff injuries; paediatric peripheral nerve injuries; predicting residual deformity following Ponseti treatment; and the Dunn procedure.