Objectives. Patient function after arthroplasty should ideally quickly improve.
It is not known which peri-operative function assessments predict
length of stay (LOS) and short-term functional recovery. The objective
of this study was to identify peri-operative functions assessments
predictive of hospital LOS and short-term function after hospital discharge
in hip or knee arthroplasty patients. Methods. In total, 108 patients were assessed peri-operatively with the
timed-up-and-go (TUG), Iowa level of assistance scale, post-operative
quality of recovery scale, readiness for hospital discharge scale,
and the Western Ontario and McMaster Osteoarthritis Index (WOMAC).
The older Americans resources and services activities of daily living
(ADL) questionnaire (OARS) was used to assess function two weeks
after discharge. . Results. Following multiple regressions, the pre- and post-operative day
two TUG was significantly associated with LOS and OARS score, while
the pre-operative WOMAC function subscale was associated with the
OARS score. Pre-operatively, a cut-off TUG time of 11.7 seconds
for LOS and 10.3 seconds for short-term recovery yielded the highest
sensitivity and specificity, while a cut-off WOMAC function score
of 48.5/100 yielded the highest sensitivity and specificity. Post-operatively,
a cut-off day two TUG time of 31.5 seconds for LOS and 30.9 seconds
for short-term function yielded the highest sensitivity and specificity. . Conclusions. The pre- and post-operative day two TUG can indicate hospital
LOS and short-term functional capacities, while the pre-operative
WOMAC function subscale can indicate short-term functional capacities. Cite this article: Bone Joint
Objectives. A lack of connection between surgeons and patients in evaluating
the outcome of total knee arthroplasty (TKA) has led to the search
for the ideal patient-reported outcome measure (PROM) to evaluate
these procedures. We hypothesised that the desired psychometric properties
of the ideal outcome tool have not been uniformly addressed in studies describing
TKA PROMS. Methods. A systematic review was conducted investigating one or more facets
of patient-reported scores for measuring primary TKA outcome. Studies
were analysed by study design, subject demographics, surgical technique,
and follow-up adequacy, with the ‘gold standard’ of psychometric
properties being systematic development, validity, reliability,
and responsiveness. Results. A total of 38 articles reported outcomes from 47 different PROMS
to 85 541 subjects at 26.3 months (standard deviation 30.8) post-operatively.
Of the 38, eight developed new scores, 20 evaluated existing scores,
and ten were cross-cultural adaptation of existing scores. Only
six of 38 surveyed studies acknowledged all ‘gold standard’ psychometric
properties. The most commonly studied PROMS were the Oxford Knee
Score, New Knee Society Score, Osteoarthritis Outcome Score, and
Western Ontario and McMaster Universities Osteoarthritis Index. Conclusions. A single, validated, reliable, and responsive PROM addressing
TKA patients’ priorities has not yet been identified. Moreover,
a clear definition of a successful procedure remains elusive. Cite this article: Bone Joint
Objectives. Temperature is known to influence muscle physiology, with the velocity of shortening, relaxation and propagation all increasing with temperature. Scant data are available, however, regarding thermal influences on energy required to induce muscle damage. Methods. Gastrocnemius and soleus muscles were harvested from 36 male rat limbs and exposed to increasing impact energy in a mechanical test rig. Muscle temperature was varied in 5°C increments, from 17°C to 42°C (to encompass the in vivo range). The energy causing non-recoverable deformation was recorded for each temperature. A measure of tissue elasticity was determined via accelerometer data, smoothed by low-pass fifth order Butterworth filter (10 kHz). Data were analysed using one-way analysis of variance (ANOVA) and significance was accepted at p = 0.05. Results. The energy required to induce muscle failure was significantly lower at muscle temperatures of 17°C to 32°C compared with muscle at core temperature, i.e., 37°C (p < 0.01). During low-energy impacts there were no differences in muscle elasticity between cold and warm muscles (p = 0.18). Differences in elasticity were, however, seen at higher impact energies (p < 0.02). Conclusion. Our findings are of particular clinical relevance, as when muscle temperature drops below 32°C, less energy is required to cause muscle tears. Muscle temperatures of 32°C are reported in ambient conditions, suggesting that it would be beneficial, particularly in colder environments, to ensure that peripheral muscle temperature is raised close to core levels prior to high-velocity exercise. Thus, this work stresses the importance of not only ensuring that the muscle groups are well stretched, but also that all muscle groups are warmed to core temperature in pre-exercise routines. Cite this article: Professor A. H. R. W. Simpson. Increased risk of muscle tears below physiological temperature ranges. Bone Joint
Objectives. T-cells are considered to play an important role in the inflammatory response causing arthroplasty failure. The study objectives were to investigate the composition and distribution of CD4+ T-cell phenotypes in the peripheral blood (PB) and synovial fluid (SF) of patients undergoing revision surgery for failed metal-on-metal (MoM) and metal-on-polyethylene (MoP) hip arthroplasties, and in patients awaiting total hip arthroplasty. Methods. In this prospective case-control study, PB and SF were obtained from 22 patients (23 hips) undergoing revision of MoM (n = 14) and MoP (n = 9) hip arthroplasties, with eight controls provided from primary hip osteoarthritis cases awaiting arthroplasty. Lymphocyte subtypes in samples were analysed using flow cytometry. Results. The percentages of CD4+ T-cell subtypes in PB were not different between groups. The CD4+ T-cells in the SF of MoM hips showed a completely different distribution of phenotypes compared with that found in the PB in the same patients, including significantly decreased CD4+ T-central memory cells (p < 0.05) and increased T-effector memory cells (p < 0.0001) in the SF. Inducible co-stimulator (ICOS) was the only co-stimulatory molecule with different expression on CD4+ CD28+ cells between groups. In PB, ICOS expression was increased in MoM (p < 0.001) and MoP (p < 0.05) cases compared with the controls. In SF, ICOS expression was increased in MoM hips compared with MoP hips (p < 0.05). Conclusions. Increased expression of ICOS on CD4+ T-cells in PB and SF of patients with failed arthroplasties suggests that these cells are activated and involved in generating immune responses. Variations in ICOS expression between MoM and MoP hips may indicate different modes of arthroplasty failure. Cite this article: Professor P. A. Revell. Increased expression of inducible co-stimulator on CD4+ T-cells in the peripheral blood and synovial fluid of patients with failed hip arthroplasties. Bone Joint
The National Institute for Health and Clinical
Excellence (NICE) has thus far relied on historical data and predominantly
industry-sponsored trials to provide evidence for venous thromboembolic
(VTE) prophylaxis in joint replacement patients. We argue that the
NICE guidelines may be reliant on assumptions that are in need of
revision. Following the publication of large scale, independent
observational studies showing little difference between low-molecular-weight
heparins and aspirin, and recent changes to the guidance provided
by other international bodies, should NICE reconsider their recommendations?. Cite this article: Bone Joint
Objectives. Normal sagittal spine-pelvis-lower extremity alignment is crucial in humans for maintaining an ergonomic upright standing posture, and pathogenesis in any segment leads to poor balance. The present study aimed to investigate how this sagittal alignment can be affected by severe knee osteoarthritis (KOA), and whether associated changes corresponded with symptoms of lower back pain (LBP) in this patient population. Methods. Lateral radiograph films in an upright standing position were obtained from 59 patients with severe KOA and 58 asymptomatic controls free from KOA. Sagittal alignment of the spine, pelvis, hip and proximal femur was quantified by measuring several radiographic parameters. Global balance was accessed according to the relative position of the C7 plumb line to the sacrum and femoral heads. The presence of chronic LBP was documented. Comparisons between the two groups were carried by independent samples t-tests or chi-squared test. Results. Patients with severe KOA showed significant backward femoral inclination (FI), hip flexion, forward spinal inclination, and higher prevalence of global imbalance (27.1% versus 3.4%, p < 0.001) compared with controls. In addition, patients with FI of 10° (n = 23) showed reduced lumbar lordosis and significant forward spinal inclination compared with controls, whereas those with FI > 10° (n = 36) presented with significant pelvic anteversion and hip flexion. A total of 39 patients with KOA (66.1%) suffered from LBP. There was no significant difference in sagittal alignment between KOA patients with and without LBP. Conclusions. The sagittal alignment of spine-pelvis-lower extremity axis was significantly influenced by severe KOA. The lumbar spine served as the primary source of compensation, while hip flexion and pelvic anteversion increased for further compensation. Changes in sagittal alignment may not be involved in the pathogenesis of LBP in this patient population. Cite this article: W. J. Wang, F. Liu, Y.W. Zhu, M.H. Sun, Y. Qiu, W. J. Weng. Sagittal alignment of the spine-pelvis-lower extremity axis in patients with severe knee osteoarthritis: A radiographic study. Bone Joint
Objectives. The PROximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial has recently demonstrated that surgery is non-superior to non-operative treatment in the management of displaced proximal humeral fractures. The objective of this study was to assess current surgical practice in the context of the PROFHER trial in terms of patient demographics, injury characteristics and the nature of the surgical treatment. Methods. A total of ten consecutive patients undergoing surgery for the treatment of a proximal humeral fracture from each of 11 United Kingdom hospitals were retrospectively identified over a 15 month period between January 2014 and March 2015. Data gathered for the 110 patients included patient demographics, injury characteristics, mode of surgical fixation, the grade of operating surgeon and the cost of the surgical implants. Results. A majority of the patients were female (66%, 73 of 110). The mean patient age was 62 years (range 18 to 89). A majority of patients met the inclusion criteria for the PROFHER trial (75%, 83 of 110). Plate fixation was the most common mode of surgery (68%, 75 patients), followed by intramedullary fixation (12%, 13 patients), reverse shoulder arthroplasty (10%, 11 patients) and hemiarthroplasty (7%, eight patients). The consultant was either the primary operating surgeon or supervising the operating surgeon in a large majority of cases (91%, 100 patients). Implant costs for plate fixation were significantly less than both hemiarthroplasty (p < 0.05) and reverse shoulder arthroplasty (p < 0.0001). Implant costs for intramedullary fixation were significantly less than plate fixation (p < 0.01), hemiarthroplasty (p < 0.0001) and reverse shoulder arthroplasty (p < 0.0001). Conclusions. Our study has shown that the majority of a representative sample of patients currently undergoing surgical treatment for a proximal humeral fracture in these United Kingdom centres met the inclusion criteria for the PROFHER trial and that a proportion of these patients may, therefore, have been effectively managed non-operatively. Cite this article: Mr B. J. F. Dean. A review of current surgical practice in the operative treatment of proximal humeral fractures: Does the PROFHER trial demonstrate a need for change? Bone Joint
Tendinopathy is a debilitating musculoskeletal
condition which can cause significant pain and lead to complete rupture
of the tendon, which often requires surgical repair. Due in part
to the large spectrum of tendon pathologies, these disorders continue
to be a clinical challenge. Animal models are often used in this
field of research as they offer an attractive framework to examine
the cascade of processes that occur throughout both tendon pathology and
repair. This review discusses the structural, mechanical, and biological
changes that occur throughout tendon pathology in animal models,
as well as strategies for the improvement of tendon healing. Cite this article: Bone Joint
Objectives. High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). Methods. We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015. Results. Our search strategy identified 1082 studies of which 115 studies were included for full article review. Following review, 17 articles were found that investigated surrogate markers of long-term outcome. These included one systematic review, one randomised control trial (RCT), one case control study and 13 case series. Validated surrogate markers included Radiostereometric Analysis (RSA) and Einzel-Bild-Röntgen-Analyse (EBRA), each measuring implant migration and wear. We identified five RSA studies (one systematic review and four case series) and four EBRA studies (one RCT and three case series). Patient Reported Outcome Measures (PROMs) at six months have been investigated but have not been validated against long-term outcomes. Conclusions. This systematic review identified two validated surrogate markers of long-term primary THA outcome: RSA and EBRA, each measuring implant migration and wear. We recommend the consideration of RSA in the pre-market testing of new implants. EBRA can be used to investigate acetabular wear but not femoral migration. Further studies are needed to validate the use of PROMs for post-market surveillance. Cite this article: T. T. Malak, J. A. J. Broomfield, A. J. R. Palmer, S. Hopewell, A. Carr, C. Brown, D. Prieto-Alhambra, S. Glyn-Jones. Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review. Bone Joint
Objectives. Hips with metal-on-metal total hip arthroplasty (MoM THA) have a high rate of adverse local tissue reactions (ALTR), often associated with hypersensitivity reactions. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) measures tissue perfusion with the parameter Ktrans (volume transfer constant of contrast agent). Our purpose was 1) to evaluate the feasibility of DCE-MRI in patients with THA and 2) to compare DCE-MRI in patients with MoM bearings with metal-on-polyethylene (MoP) bearings, hypothesising that the perfusion index Ktrans in hips with MoM THA is higher than in hips with MoP THA. Methods. In this pilot study, 16 patients with primary THA were recruited (eight MoM, eight MoP). DCE-MRI of the hip was performed at 1.5 Tesla (T). For each patient, Ktrans was computed voxel-by-voxel in all tissue lateral to the bladder. The mean Ktrans for all voxels was then calculated. These values were compared with respect to implant type and gender, and further correlated with clinical parameters. Results. There was no significant difference between the two bearing types with both genders combined. However, dividing patients by THA bearing and gender, women with MoM bearings had the highest Ktrans values, exceeding those of women with MoP bearings (0.067 min. −1. versus 0.053 min. −1. ; p-value < 0.05) and men with MoM bearings (0.067 min. −1. versus 0.034 min. −1. ; p-value < 0.001). Considering only the men, patients with MoM bearings had lower Ktrans than those with MoP bearings (0.034 min. −1. versus 0.046 min. −1. ; p < 0.05). Conclusion. DCE-MRI is feasible to perform in tissues surrounding THA. Females with MoM THA show high Ktrans values in DCE-MRI, suggesting altered tissue perfusion kinematics which may reflect relatively greater inflammation. Cite this article: Dr P. E. Beaule. Perfusion MRI in hips with metal-on-metal and metal-on-polyethylene total hip arthroplasty: A pilot stud. Bone Joint
Objectives. The evidence base to inform the management of Achilles tendon
rupture is sparse. The objectives of this research were to establish
what current practice is in the United Kingdom and explore clinicians’
views on proposed further research in this area. This study was
registered with the ISRCTN (ISRCTN68273773) as part of a larger
programme of research. Methods. We report an online survey of current practice in the United
Kingdom, approved by the British Orthopaedic Foot and Ankle Society
and completed by 181 of its members. A total of ten of these respondents
were invited for a subsequent one-to-one interview to explore clinician
views on proposed further research in this area. Results. The survey showed wide variations in practice, with patients
being managed in plaster cast alone (13%), plaster cast followed
by orthoses management (68%), and orthoses alone (19%). Within these
categories, further variation existed regarding the individual rehabilitation
facets, such as the length of time worn, the foot position within
them and weight-bearing status. The subsequent interviews reflected
this clinical uncertainty and the pressing need for definitive research. Conclusions. The gap in evidence in this area has resulted in practice in
the United Kingdom becoming varied and based on individual opinion.
Future high-quality randomised trials on this subject are supported
by the clinical community. Cite this article: Bone Joint
Objectives. The Oxford Hip and Knee Scores (OHS, OKS) have been demonstrated
to vary according to age and gender, making it difficult to compare
results in cohorts with different demographics. The aim of this
paper was to calculate reference values for different patient groups
and highlight the concept of normative reference data to contextualise an
individual’s outcome. Methods. We accessed prospectively collected OHS and OKS data for patients
undergoing lower limb joint arthroplasty at a single orthopaedic
teaching hospital during a five-year period.
T-scores were calculated based on the OHS and OKS distributions. . Results. Data were obtained from 3203 total hip arthroplasty (THA) patients
and 2742 total knee arthroplasty (TKA) patients. The mean age of
the patient was 68.0 years (. sd. 11.3, 58.4% women) in the
THA group and in 70.2 (. sd. 9.4; 57.5% women) in the TKA
group. T-scores were calculated for age and gender subgroups by
operation. Different T-score thresholds are seen at different time
points pre and post surgery. Values are further stratified by operation (THA/TKA)
age and gender. Conclusions. Normative data interpretation requires a fundamental shift in
the thinking as to the use of the Oxford Scores. Instead of reporting
actual score points, the patient is rated by their relative position
within the group of all patients undergoing the same procedure.
It is proposed that this form of transformation is beneficial (a)
for more appropriately comparing different patient cohorts and (b)
informing an individual patient how they are progressing compared
with others of their age and gender. Cite this article: Bone Joint
Objectives. Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods. A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results. In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties. Conclusion. According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties. Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint
Objectives. Our study aimed to examine not only the incidence but also the
impact of noise from two types of total hip replacement articulations:
ceramic-on-ceramic and ceramic-on-polyethylene. . Methods . We performed a case-controlled study comparing subjective and
objective questionnaire scores of patients receiving a ceramic-on-ceramic
or a ceramic-on-polyethylene total hip replacement by a single surgeon. Results. There was a threefold higher incidence of noise from patients
in the ceramic-on-ceramic group compared with the control group.
The impact of this noise was significant for patients both subjectively
and objectively. Conclusions. This study reports a high patient impact of noise from ceramic-on-ceramic
total hip replacements. This has led to a change in practice by
the principal author. Cite this article: Bone Joint
Objective. Clinical studies of patients with bone sarcomas have been challenged
by insufficient numbers at individual centres to draw valid conclusions.
Our objective was to assess the feasibility of conducting a definitive
multi-centre randomised controlled trial (RCT) to determine whether
a five-day regimen of post-operative antibiotics, in comparison
to a
24-hour regimen, decreases surgical site infections in patients
undergoing endoprosthetic reconstruction for lower extremity primary
bone tumours. . Methods. We performed a pilot international multi-centre RCT. We used
central randomisation to conceal treatment allocation and sham antibiotics
to blind participants, surgeons, and data collectors. We determined
feasibility by measuring patient enrolment, completeness of follow-up,
and protocol deviations for the antibiotic regimens. . Results. We screened 96 patients and enrolled 60 participants (44 men
and 16 women) across 21 sites from four countries over 24 months
(mean 2.13 participants per site per year, standard deviation 2.14).
One participant was lost to follow-up and one withdrew consent.
Complete data were obtained for 98% of eligible patients at two
weeks, 83% at six months, and 73% at one year (the remainder with
partial data or pending queries). In total, 18 participants missed
at least one dose of antibiotics or placebo post-operatively, but
93% of all post-operative doses were administered per protocol. . Conclusions. It is feasible to conduct a definitive multi-centre RCT of post-operative
antibiotic regimens in patients with bone sarcomas, but further
expansion of our collaborative network will be critical. We have
demonstrated an ability to coordinate in multiple countries, enrol
participants, maintain protocol adherence, and minimise losses to
follow-up. Cite this article: Bone Joint
Objectives. The clinical utility of routine cross sectional imaging of the
abdomen and pelvis in the screening and surveillance of patients
with primary soft-tissue sarcoma of the extremities for metastatic
disease is controversial, based on its questionable yield paired
with concerns regarding the risks of radiation exposure, cost, and
morbidity resulting from false positive findings. Methods. Through retrospective review of 140 patients of all ages (mean
53 years; 2 to 88) diagnosed with soft-tissue sarcoma of the extremity
with a mean follow-up of 33 months (0 to 291), we sought to determine
the overall incidence of isolated abdominopelvic metastases, their
temporal relationship to chest involvement, the rate of false positives, and
to identify disparate rates of metastases based on sarcoma subtype. Results. A total of four patients (2.9%) exhibited isolated abdominopelvic
metastatic disease during the surveillance period. In all cases
of concomitant chest and abdominopelvic disease, chest involvement
preceded abominopelvic involvement. There was a significant false
positive rate requiring invasive workup. Conclusions. In the setting of a relative paucity of evidence concerning a
rare disease process and in difference to recently published investigations,
we add a clinical cohort not supportive of routine cross sectional
imaging of the abdomen and pelvis. Cite this article: Bone Joint
Construction of a functional skeleton is accomplished
through co-ordination of the developmental processes of chondrogenesis,
osteogenesis, and synovial joint formation. Infants whose movement in
utero is reduced or restricted and who subsequently suffer
from joint dysplasia (including joint contractures) and thin hypo-mineralised
bones, demonstrate that embryonic movement is crucial for appropriate
skeletogenesis. This has been confirmed in mouse, chick, and zebrafish
animal models, where reduced or eliminated movement consistently yields
similar malformations and which provide the possibility of experimentation
to uncover the precise disturbances and the mechanisms by which
movement impacts molecular regulation. Molecular genetic studies have
shown the important roles played by cell communication signalling
pathways, namely Wnt, Hedgehog, and transforming growth factor-beta/bone
morphogenetic protein. These pathways regulate cell behaviours such
as proliferation and differentiation to control maturation of the
skeletal elements, and are affected when movement is altered. Cell
contacts to the extra-cellular matrix as well as the cytoskeleton
offer a means of mechanotransduction which could integrate mechanical
cues with genetic regulation. Indeed, expression of cytoskeletal
genes has been shown to be affected by immobilisation. In addition
to furthering our understanding of a fundamental aspect of cell control
and differentiation during development, research in this area is
applicable to the engineering of stable skeletal tissues from stem
cells, which relies on an understanding of developmental mechanisms
including genetic and physical criteria. A deeper understanding
of how movement affects skeletogenesis therefore has broader implications
for regenerative therapeutics for injury or disease, as well as
for optimisation of physical therapy regimes for individuals affected
by skeletal abnormalities. Cite this article: Bone Joint
The surgical community is plagued with a reputation
for both failing to engage and to deliver on clinical research.
This is in part due to the absence of a strong research culture, however
it is also due to a multitude of barriers encountered in clinical
research; particularly those involving surgical interventions. ‘Trauma’
amplifies these barriers, owing to the unplanned nature of care,
unpredictable work patterns, the emergent nature of treatment and
complexities in the consent process. This review discusses the barriers
to clinical research in surgery, with a particular emphasis on trauma.
It considers how barriers may be overcome, with the aim to facilitate
future successful clinical research. Cite this article: Bone Joint
Objectives. There remains conflicting evidence regarding cortical bone strength
following bisphosphonate therapy. As part of a study to assess the
effects of bisphosphonate treatment on the healing of rat tibial
fractures, the mechanical properties and radiological density of
the uninjured contralateral tibia was assessed. Methods. Skeletally mature aged rats were used. A total of 14 rats received
1µg/kg ibandronate (iban) daily and 17 rats received 1 ml 0.9% sodium
chloride (control) daily. Stress at failure and toughness of the
tibial diaphysis were calculated following four-point bending tests. Results. Uninjured cortical bone in the iban group had a significantly
greater mean (standard deviation (. sd. )), p <
0.001, stress
at failure of 219.2 MPa (. sd. 45.99) compared with the control
group (169.46 MPa (. sd. 43.32)) following only nine weeks
of therapy. Despite this, the cortical bone toughness and work to
failure was similar. There was no significant difference in radiological
density or physical dimensions of the cortical bone. Conclusions. Iban therapy increases the stress at failure of uninjured cortical
bone. This has relevance when normalising the strength of repair
in a limb when comparing it with the unfractured limb. However,
the 20% increase in stress at failure with iban therapy needs to
be interpreted with caution as there was no corresponding increase
in toughness or work to failure. Further research is required in
this area, especially with the increasing clinical burden of low-energy
diaphyseal femoral fractures following prolonged use of bisphosphonates. Cite this article: Bone Joint
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: Bone Joint
