The aim of this study was to investigate the
possible benefit of large-head metal-on-metal bearing on a stem
for primary hip replacement compared with a 28 mm diameter conventional
metal-on-polyethylene bearing in a prospective randomised controlled
trial. We investigated cemented stem behaviour between these two
different bearings using Einzel-Bild-Röntgen-Analyse, clinical and
patient reported measures (Harris hip score, Western Ontario and
McMaster Universities osteoarthritis index, Short Form-36 and satisfaction)
and whole blood metal ion levels at two years. A power study indicated
that 50 hips were needed in each group to detect subsidence of >
5 mm at two years with a
p-value of <
0.05. Significant improvement (p <
0.001) was found in the mean
clinical and patient reported outcomes at two years for both groups.
Comparison of outcomes between the groups at two years showed no
statistically significant difference for mean stem migration, clinical
and patient reported outcomes; except overall patient satisfaction which
was higher for metal-on-metal group (p = 0.05). Metal ion levels
were raised above the Medicines and Healthcare products Regulatory
Agency advised safety level (7 µg per litre) in 20% of the metal-on-metal
group and in one patient in metal-on-polyethylene group (who had
a metal-on-metal implant on the contralateral side). Two patients
in the metal-on-metal group were revised, one for pseudotumour and
one for peri-prosthetic fracture. Use of large modular heads is associated with a risk of raised
whole blood metal ion levels despite using a proven bearing from
resurfacing. The head-neck junction or excess stem micromotion are
possibly the weak links warranting further research.
Our objective was to examine the rate of revision
and its predictive factors in patients undergoing total shoulder arthroplasty
(TSA). We used prospectively collected data from the Mayo Clinic
Total Joint Registry to examine five-, ten- and 20-year revision-free
survival following TSA and the predictive factors. We examined patient
characteristics (age, gender, body mass index, comorbidity), implant
fixation (cemented
The aim of this study was to investigate genetic influences on the development and progression of tears of the rotator cuff. From a group of siblings of patients with a tear of the rotator cuff and of controls studied five years earlier, we determined the prevalence of tears of the rotator cuff with and without associated symptoms using ultrasound and the Oxford Shoulder Score. In the five years since the previous assessment, three of 62 (4.8%) of the sibling group and one of the 68 (1.5%) controls had undergone shoulder surgery. These subjects were excluded from the follow-up. Full-thickness tears were found in 39 of 62 (62.9%) siblings and in 15 of 68 (22.1%) controls (p = 0.0001). The relative risk of full-thickness tears in siblings as opposed to controls was 2.85 (95% confidence interval (CI) 1.75 to 4.64), compared to 2.42 (95% CI 1.77 to 3.31) five years earlier. Full-thickness tears associated with pain were found in 30 of 39 (76.9%) tears in the siblings and in eight of 15 (53.3%) tears in the controls (p = 0.045). The relative risk of pain associated with a full-thickness tear in the siblings as opposed to the controls was 1.44 (95% CI 2.04 to 8.28) (p = 0.045). In the siblings group ten of 62 (16.1%) had progressed in terms of tear size or development compared to one of 68 (1.5%) in the control group which had increased in size. Full-thickness rotator cuff tears in siblings are significantly more likely to progress over a period of five years than in a control population. This implies that genetic factors have a role, not only in the development but also in the progression of full-thickness tears of the rotator cuff.
We conducted a systematic review and meta-analysis
of randomised controlled trials evaluating the effect of tranexamic
acid (TXA) upon blood loss and transfusion in primary total knee
replacement. The review used the generic evaluation tool designed
by the Cochrane Bone, Joint and Muscle Trauma Group. A total of
19 trials were eligible: 18 used intravenous administration, one
also evaluated oral dosing and one trial evaluated topical use.
TXA led to a significant reduction in the proportion of patients
requiring blood transfusion (risk ratio (RR) 2.56, 95% confidence
interval (CI) 2.1 to 3.1, p <
0.001; heterogeneity I2 =
75%; 14 trials, 824 patients). Using TXA also reduced total blood
loss by a mean of 591 ml (95% CI 536 to 647, p <
0.001; I2 =
78%; nine trials, 763 patients). The clinical interpretation of
these findings is limited by substantial heterogeneity. However,
subgroup analysis of high-dose (>
4 g) TXA showed a plausible consistent
reduction in blood transfusion requirements (RR 5.33; 95% CI 2.44
to 11.65, p <
0.001; I2 = 0%), a finding that should
be confirmed by a further well-designed trial. The current evidence
from trials does not support an increased risk of deep-vein thrombosis
(13 trials, 801 patients) or pulmonary embolism (18 trials, 971
patients) due to TXA administration.
The poor reporting and use of statistical methods in orthopaedic papers has been widely discussed by both clinicians and statisticians. A detailed review of research published in general orthopaedic journals was undertaken to assess the quality of experimental design, statistical analysis and reporting. A representative sample of 100 papers was assessed for compliance to CONSORT and STROBE guidelines and the quality of the statistical reporting was assessed using a validated questionnaire. Overall compliance with CONSORT and STROBE guidelines in our study was 59% and 58% respectively, with very few papers fulfilling all criteria. In 37% of papers patient numbers were inadequately reported; 20% of papers introduced new statistical methods in the ‘results’ section not previously reported in the ‘methods’ section, and 23% of papers reported no measurement of error with the main outcome measure. Taken together, these issues indicate a general lack of statistical rigour and are consistent with similar reviews undertaken in a number of other scientific and clinical research disciplines. It is imperative that the orthopaedic research community strives to improve the quality of reporting; a failure to do so could seriously limit the development of future research.
Although the use of constrained cemented arthroplasty to treat distal femoral fractures in elderly patients has some practical advantages over the use of techniques of fixation, concerns as to a high rate of loosening after implantation of these prostheses has raised doubts about their use. We evaluated the results of hinged total knee replacement in the treatment of 54 fractures in 52 patients with a mean age of 82 years (55 to 98), who were socially dependent and poorly mobile. Within the first year after implantation 22 of the 54 patients had died, six had undergone a further operation and two required a revision of the prosthesis. The subsequent rate of further surgery and revision was low. A constrained knee prosthesis offers a useful alternative treatment to internal fixation in selected elderly patients with these fractures, and has a high probability of surviving as long as the patient into whom it has been implanted.
The aim of this study was to determine the comorbid risk factors for failure in young patients who undergo fixation of a displaced fracture of the femoral neck. We identified from a prospective database all such patients ≤ 60 years of age treated with reduction and internal fixation. The main outcome measures were union, failure of fixation, nonunion and the development of avascular necrosis. There were 122 patients in the study. Union occurred in 83 patients (68%) at a mean follow-up of 58 months (18 to 155). Complications occurred in 39 patients (32%) at a mean of 11 months (0.5 to 39). The rate of nonunion was 7.4% (n = 9) and of avascular necrosis was 11.5% (n = 14). Failures were more common in patients over 40 years of age (p = 0.03). Univariate analysis identified that delay in time to fixation (>
24 hours), alcohol excess and pre-existing renal, liver or respiratory disease were all predictive of failure (all p <
0.05). Of these, alcohol excess, renal disease and respiratory disease were most predictive of failure on multivariate analysis. Younger patients with fractures of the femoral neck should be carefully evaluated for comorbidities that increase the risk of failure after reduction and fixation. In patients with a history of alcohol abuse, renal or respiratory disease, arthroplasty should be considered as an alternative treatment.
We report the mid- to long-term (mean 20.3 years, 10 to 32.5) results of the Chiari pelvic osteotomy in patients with pre- to advanced stage osteoarthritis in dysplastic hips. We followed 163 Japanese patients (173 hips) with a mean age at surgery of 20 years (9 to 54). Overall, 124 hips (72%) had satisfactory results, with Harris hip scores ≥ 80. Satisfactory results were seen in 105 of 134 hips with pre- or early osteoarthritis (78%) and 19 of 39 hips with advanced osteoarthritis (49%). A total of 15 hips (9%) underwent a total hip replacement (THR) with a mean interval between osteotomy and THR of 16.4 years. With conversion to THR as the endpoint, the 30-year survival rate was 85.9% (95% confidence interval 82.3 to 89.5). It was 91.8% for patients with pre- or early osteoarthritis and 43.6% for those with advanced osteoarthritis (p < 0.001). We now perform the Chiari osteotomy for patients with dysplastic hips showing poor joint congruency and who prefer a joint-conserving procedure to THR.
We conducted a prospective randomised controlled trial to compare the standard Ponseti plaster method with an accelerated method for the treatment of idiopathic congenital talipes equinovarus. The standard weekly plaster-change method was accelerated to three times per week. We hypothesised that both methods would be equally effective in achieving correction. A total of 40 consecutive patients (61 feet) were entered into the trial. The initial median Pirani score was 5.5 (95% confidence interval 4.5 to 6.0) in the accelerated group and 5.0 (95% confidence interval 4.0 to 5.0) in the standard control group. The scores decreased by an average 4.5 in the accelerated group and 4.0 in the control group. There was no significant difference in the final Pirani score between the two groups (chi-squared test, p = 0.308). The median number of treatment days in plaster was 16 in the accelerated group and 42 in the control group (p <
0.001). Of the 19 patients in the accelerated group, three required plaster treatment for more than 21 days and were then assigned to the standard control method. Of the 40 patients, 36 were followed for a minimum of six months. These results suggest that comparable outcomes can be achieved with an accelerated Ponseti method. The ability to complete all necessary manipulations within a three-week period facilitates treatment where patients have to travel long distances.
A total of 80 patients with an acute rupture of tendo Achillis were randomised to operative repair using an open technique (39 patients) or non-operative treatment in a cast (41 patients). Patients were followed up for one year. Outcome measures included clinical complications, range of movement of the ankle, the Short Musculoskeletal Function Assessment (SMFA), and muscle function dynamometry evaluating dorsiflexion and plantar flexion of the ankle. The primary outcome measure was muscle dynamometry. Re-rupture occurred in two of 37 patients (5%) in the operative group and four of 39 (10%) in the non-operative group, which was not statistically significant (p = 0.68). There was a slightly greater range of plantar flexion and dorsiflexion of the ankle in the operative group at three months which was not statistically significant, but at four and six months the range of dorsiflexion was better in the non-operative group, although this did not reach statistically significance either. After 12 weeks the peak torque difference of plantar flexion compared with the normal side was less in the operative than the non-operative group (47% We were unable to show a convincing functional benefit from surgery for patients with an acute rupture of the tendo Achillis compared with conservative treatment in plaster.
The Oxford unicompartmental knee replacement (UKR) was designed to minimise wear utilising a fully-congruent, mobile, polyethylene bearing. Wear of polyethylene is a significant cause of revision surgery in UKR in the first decade, and the incidence increases in the second decade. Our study used model-based radiostereometric analysis to measure the combined wear of the upper and lower bearing surfaces in 13 medial-compartment Oxford UKRs at a mean of 20.9 years (17.2 to 25.9) post-operatively. The mean linear penetration of the polyethylene bearing was 1.04 mm (0.307 to 2.15), with a mean annual wear rate of 0.045 mm/year (0.016 to 0.099). The annual wear rate of the phase-2 bearings (mean 0.022 mm/year) was significantly less (p = 0.01) than that of phase-1 bearings (mean 0.07 mm/year). The linear wear rate of the Oxford UKR remains very low into the third decade. We believe that phase-2 bearings had lower wear rates than phase-1 implants because of the improved bearing design and surgical technique which decreased the incidence of impingement. We conclude that the design of the Oxford UKR gives low rates of wear in the long term.
We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene. The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I2 = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery.
We report a systematic review and meta-analysis of published randomised controlled trials evaluating the efficacy of tranexamic acid (TXA) in reducing blood loss and transfusion in total hip replacement (THR). The data were evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. We identified 11 clinical trials which were suitable for detailed extraction of data. There were no trials that used TXA in revision THR. A total of seven studies (comprising 350 patients) were eligible for the blood loss outcome data. The use of TXA reduced intra-operative blood loss by a mean of 104 ml (95% confidence interval (CI) −164 to −44, p = 0.0006, heterogeneity I2 0%), postoperative blood loss by a mean of 172 ml (95% CI −263 to −81, p = 0.0002, heterogeneity I2 63%) and total blood loss by a mean of 289 ml (95% CI −440 to −138, p <
0.0002, heterogeneity I2 54%). TXA led to a significant reduction in the proportion of patients requiring allogeneic blood transfusion (risk difference −0.20, 95% CI −0.29 to −0.11, p <
0.00001, I2 15%). There were no significant differences in deep-vein thrombosis, pulmonary embolism, infection rates or other complications among the study groups.
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.
This was a safety study where the hypothesis was that the newer-design CPCS femoral stem would demonstrate similar early clinical results and micromovement to the well-established Exeter stem. Both are collarless, tapered, polished cemented stems, the only difference being a slight lateral to medial taper with the CPCS stem. A total of 34 patients were enrolled in a single-blinded randomised controlled trial in which 17 patients received a dedicated radiostereometric CPCS stem and 17 a radiostereometric Exeter stem. No difference was found in any of the outcome measures pre-operatively or post-operatively between groups. At two years, the mean subsidence for the CPCS stem was nearly half that seen for the Exeter stem (0.77 mm (−0.943 to 1.77) and 1.25 mm (0.719 to 1.625), respectively; p = 0.032). In contrast, the mean internal rotation of the CPCS stem was approximately twice that of the Exeter (1.61° (−1.07° to 4.33°) and 0.59° (0.97° to 1.64°), respectively; p = 0.048). Other migration patterns were not significantly different between the stems. The subtle differences in designs may explain the different patterns of migration. Comparable migration with the Exeter stem suggests that the CPCS design will perform well in the long term.
We present the long-term outcome, at a median of 18 years (12.8 to 23.5) of open posterior bone block stabilisation for recurrent posterior instability of the shoulder in a heterogenous group of 11 patients previously reported on in 2001 at a median follow-up of six years. We found that five (45%) would not have chosen the operation again, and that four (36%) had further posterior dislocation. Clinical outcome was significantly worse after 18 years than after six years of follow-up (median Rowe score of 60 versus 90 (p = 0.027)). The median Western Ontario Shoulder Index was 60% (37% to 100%) at 18 years’ follow-up, which is a moderate score. At the time of surgery four (36%) had glenohumeral radiological osteoarthritis, which was present in all after 18 years. This study showed poor long-term results of the posterior bone block procedure for posterior instability and a high rate of glenohumeral osteoarthritis although three patients with post-traumatic instability were pleased with the result of their operations.
Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.
We performed 96 Birmingham resurfacing arthroplasties of the hip in 71 consecutive patients with avascular necrosis of the femoral head. A modified neck-capsule-preserving approach was used which is described in detail. The University of California, Los Angeles outcome score, the radiological parameters and survival rates were assessed. The mean follow-up was for 5.4 years (4.0 to 8.1). All the patients remained active with a mean University of California, Los Angeles activity score of 6.86 (6 to 9). Three hips failed, giving a cumulative survival rate of 95.4%. With failure of the femoral component as the endpoint, the cumulative survival rate was 98.0%. We also describe the combined abduction-valgus angle of the bearing couple, which is the sum of the inclination angle of the acetabular component and the stem-shaft angle, as an index of the optimum positioning of the components in the coronal plane. Using a modified surgical technique, it is possible to preserve the femoral head in avascular necrosis by performing hip resurfacing in patients with good results.
Delayed rather than early reconstruction of the anterior cruciate ligament is the current recommended treatment for injury to this ligament since it is thought to give a better functional outcome. We randomised 105 consecutive patients with injury associated with chondral lesions no more severe than grades 1 and 2 and/or meniscal tears which only required trimming, to early (<
two weeks) or delayed (>
four to six weeks) reconstruction of the anterior cruciate ligament using a quadrupled hamstring graft. All operations were performed by a single surgeon and a standard rehabilitation regime was followed in both groups. The outcomes were assessed using the Lysholm score, the Tegner score and measurement of the range of movement. Stability was assessed by clinical tests and measurements taken with the KT-1000 arthrometer, with all testing performed by a blinded uninvolved experienced observer. A total of six patients were lost to follow-up, with 48 patients assigned to the delayed group and 51 to the early group. None was a competitive athlete. The mean interval between injury and the surgery was seven days (2 to 14) in the early group and 32 days (29 to 42) in the delayed group. The mean follow-up was 32 months (26 to 36). The results did not show a statistically significant difference for the Lysholm score (p = 0.86), Tegner activity score (p = 0.913) or the range of movement (p = 1). Similarly, no distinction could be made for stability testing by clinical examination (p = 0.56) and measurements with the KT-1000 arthrometer (p = 0.93). Reconstruction of the anterior cruciate ligament gave a similar clinical and functional outcome whether performed early (<
two weeks) or late at four to six weeks after injury.
We determined the age-specific incidence of a second fracture of the hip and compared it with that of a primary fracture in a study population drawn from 6331 patients admitted to Nottingham University Hospital with a primary fracture of the hip over a period of 8.5 years. The incidence of a second fracture was determined using survival analysis. The mean age-specific incidence rates of primary hip fracture were calculated using census data. The overall incidence of a second fracture was 2.7% at one year and 7.8% at 8.5 years. That of a primary fracture was 50 per 100 000 in women aged 55 to 64 years rising to 3760 in those aged 84 years and over. The incidence of a second fracture in women aged 55 to 64 years was 2344 per 100 000. Patients of this age had a relative risk of 45 (95% confidence interval 13 to 155) for further fracture when compared with the population at risk of a first fracture. The incidence of a second fracture in women aged >
84 years was 2451 per 100 000 (relative risk 0.7, 95% confidence interval 0.5 to 0.9). A similar trend was seen in men. Patients sustaining a primary fracture of the hip between the ages of 55 and 64 years have a much greater risk of further fracture than the normal population, whereas those over 84 years have a similar risk. These findings have important implications for the provision of fracture prevention services in primary and secondary care.