Aims

Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures .

Introduction. Unstable ankle fractures are routinely managed operatively. Due to soft-tissue and implant related complications, there has been recent literature reporting on the non-operative management of well-reduced medial malleolus fractures following fibular stabilisation, but with limited evidence supporting routine application. This trial assessed the superiority of internal fixation of well-reduced (displacement ≤2mm) medial malleolus fractures compared with non-fixation following fibular stabilisation. Methods and participants. Superiority, pragmatic, parallel, prospective randomised clinical trial conducted over a four year period. A total of 154 adult patients with a bi- or trimalleolar fractures were recruited from a single centre. Open injuries and vertical medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at one-year post-randomisation. Complications and radiographic outcomes were documented over the follow-up period. Results. Among 154 participants (mean age, 56.5 years; 119 women [77%]), 144 [94%] completed the trial. At one-year the median OMAS was 80 (IQR, 60–90) in the fixation group compared with 72.5 (IQR, 55–90) in the non-fixation group (p=0.17). Complication rates were comparable. Significantly more patients in the non-fixation group developed a radiographic non-union (20% vs 0%; p<0.001), with the majority (n=8/13) clinically asymptomatic and one patient required surgical re-intervention for this. Fracture type and reduction quality appeared to influence fracture union and patient outcome. Conclusions. In this randomised clinical trial comparing internal fixation of well-reduced medial malleolus fractures with non-fixation, following fibular stabilisation, fixation was not superior according to the primary outcome. However, 1 in 5 patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the future implications require surveillance. These results may support selective non-fixation of anatomically reduced medial malleolus fractures

Background. Infiltration is considered the first treatment option for symptomatic Morton's neuroma and can be performed with various medications. The aim of this study was to compare the effects of hyaluronic acid infiltration versus corticosteroid injection in the treatment of Morton's neuroma. Methods. A randomised clinical trial was conducted with 46 patients (50 feet) diagnosed with Morton's neuroma. After randomisation, the control group (CG) received three injections (one per week) of triamcinolone (Triancil®) guided by ultrasound, while the study group (SG) received three applications of hyaluronic acid (Osteonil Plus®). Patients were followed up for six months after the intervention. The primary outcome measure used was the Visual Pain Analog Scale (VAS). Secondary endpoints included patient-reported outcome measures using the American Orthopaedic Foot & Ankle Society (AOFAS) score and complications. Results. Both groups showed significant improvement in VAS and AOFAS scores (p < 0.001). The CG showed greater improvement than the SG in the VAS (p < 0.05) and AOFAS (p < 0.001) variables. Four patients in the CG experienced skin hypochromia at the injection site, while there were no complications in the SG. Conclusion. Ultrasound-guided hyaluronic acid infiltration in Morton's Neuroma proved to be safe, showing improvement in pain and function after six months of follow-up, without major complications, but with a significantly lower improvement when compared to corticosteroid injection. Taking into account cost implications and the potential for longer lasting improvement from viscosupplementation further medium- and long-term studies are needed

Aim. Rifampicin and fluoroquinolone based therapy is generally considered as first-choice targeted oral antimicrobial therapy for staphylococcal prosthetic joint infections (PJI) treated with debridement, antibiotics and implant retention (DAIR). Alternative equally effective antimicrobial strategies are urgently needed due to toxicity and drug-drug interactions that frequently occur with this strategy. Data from recent clinical studies suggests equipoise for other antimicrobial treatment regimens. The objective of the Rifampicin Combination Therapy versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection (RiCOTTA)-trial is to evaluate whether monotherapy with clindamycin is non-inferior to rifampicin/fluoroquinolone combination therapy in patients with staphylococcal PJI that are treated with DAIR. Method. The RiCOTTA-trial is a multicenter, non-inferiority, open-label, randomized controlled trial evaluating clindamycin versus rifampicin/fluoroquinolone combination therapy in the oral treatment phase in patients with staphylococcal PJI managed with DAIR. The trial is performed in 16 hospitals in the Netherlands. Eligible patients are adults with staphylococcal knee or hip PJI managed by DAIR. Patients are included one to six days before antibiotic treatment is switched from intravenous to oral therapy. Patients with a contraindication for rifampicin, with a megaprosthesis or who receive intravenous antibiotics for more than three weeks after initial debridement are excluded. Primary outcome is treatment success one year after finishing antimicrobial treatment. Success is defined as the absence of: i. Infection related re-surgery, ii. New episode of antibiotic treatment for infection of the index joint after the initial treatment phase of 12 weeks, iii. Ongoing use of antibiotics for the index joint at the end of follow-up, iv. Death. The estimated treatment success of rifampicin combination therapy is 85% and the monotherapy strategy is considered not inferior when the difference in treatment success will be less than 10%. Enrolment of 158 patients per group (316 in total) is needed to confirm non-inferiority of monotherapy with a power of 80%. The trial is currently open for enrolment. The study is approved by the Medical Ethics Committee Leiden, the Hague, Delft, the Netherlands and registered under EU trial number 2022-501620-26-00 in Clinical Trial Information System. Conclusions. Currently, the RiCOTTTA study is the largest randomised clinical trial that compares targeted oral monotherapy with rifampicin combination treatment for staphylococcal PJI. Noninferiority of monotherapy would result in a change in national PJI guidelines and enable clinicians to use a more patient-tailored approach when considering antibiotics for patients during the oral treatment phase of PJI

The promotion and practice of evidence-based medicine necessitates a critical evaluation of medical literature including the “gold standard” of randomised clinical trials. Recent studies have examined the quality of randomised clinical trials in various surgical specialties, but no study has focused on pediatric orthopedics. The purpose of this study was to assess and describe the quality of randomised clinical trials published in the last ten years in journals with high clinical impact in pediatric orthopaedics. All of the randomised clinical trials in pediatric orthopedics published in five well-recognised journals between 1995–2005 were reviewed using the Detsky Quality Assessment Scale. The mean percentage score on the Detsky Scale was 53% (95% CI: 46%–60%). Only seven (19%) of the articles satisfied the threshold for a satisfactory level of methodologic quality (Detsky > 75%). The majority of randomised clinical trials in pediatric orthopedics that are published in well-recognised, peer-reviewed journals demonstrate substantial deficiencies in methodologic quality. Particular areas of weakness include inadequate rigor and reporting of randomization methods, use of inappropriate or poorly-described outcome measures, inadequate description of inclusion and exclusion criteria and inappropriate statistical analysis. Further efforts are necessary to improve the conduct and reporting of clinical trials in this field in order to avoid inadvertent misinformation of the clinical community

There has been ongoing debate for many years on the relative merits of routine tourniquet use while performing a total knee replacement. Interestingly there have been many retrospective reviews and opinion articles on the topic, but little in the way of well powered prospective randomised clinical trials. Those that dislike the premise of routine tourniquet use usually cite a list of either very rare complications, or theoretical concerns (nerve damage, muscle function, wound healing issues). Like most debate topics however, the issue is usually a shade of grey, rather than black and white, if the pro/con arguments are evaluated individually. There can be little debate that intraoperative blood loss is less with the use of a tourniquet. This has been demonstrated in multiple studies and is clearly intuitively obvious. Interestingly the overall blood loss (intraop + postop) may however be the same regardless of tourniquet use. Having a dry operative field however is important in achieving adequate cement fixation, and if tourniquet use is not employed, an alternative should be. There is an overwhelming body of literature that supports the understanding that increased OR time directly correlates to increased infection rates in total joint arthroplasty. Proponents of not using a tourniquet will often have alternates to achieving a dry operative field that clearly add time to the procedure – meticulous hemostasis, air delivery systems, etc. This increased OR time may come at the cost of increased infection risk. There is clearly a need for well-designed randomised clinical trials evaluating the practice of routine tourniquet use in TKA. Any trial done however must look critically at factors such as OR time, costs of alternatives, and potential long-term outcome effects

There has been ongoing debate for many years on the relative merits of routine tourniquet use while performing a total knee replacement. Interestingly there have been many retrospective reviews and opinion articles on the topic, but little in the way of well powered prospective randomised clinical trials. Those that dislike the premise of routine tourniquet use usually cite a list of either very rare complications, or theoretical concerns (nerve damage, muscle function, wound healing issues). Like most debate topics, however, the issue is usually a shade of grey, rather than black and white, if the pro/con arguments are evaluated individually. 1. Blood Loss. There can be little debate that intra-operative blood loss is less with the use of a tourniquet. This has been demonstrated in multiple studies and is clearly intuitively obvious. Interestingly the overall blood loss (intra-op + post-op) may, however, be the same regardless of tourniquet use. Having a dry operative field, however, is important in achieving adequate cement fixation, and if tourniquet use is not employed, an alternative should be. 2. OR time. There is an overwhelming body of literature that supports the understanding that increased OR time directly correlates to increased infection rates in total joint arthroplasty. Proponents of not using a tourniquet will often have alternates to achieving a dry operative field that clearly add time to the procedure – meticulous hemostasis, air delivery systems, etc. This increased OR time may come at the cost of increased infection risk. There is clearly a need for well-designed randomised clinical trials evaluating the practice of routine tourniquet use in TKA. Any trial done, however, must look critically at factors such as OR time, costs of alternatives, and potential long-term outcome effects

Resurfacing the patella is performed the majority of the time in the United States and in many regions it is considered standard practice. In many countries, however, the patella is left un-resurfaced an equal amount of the time or even rarely ever resurfaced. Patella resurfacing is not a simple or benign procedure. There are numerous negative sequelae of resurfacing including loosening, fragmentation, avascular necrosis, lateral facet pain, stress fracture, acute fracture, late fracture, and restricted motion. In a study by Berend, Ritter, et al, failures of the patella component were reported 4.2% of the time at an average of only 2.6 years. A study was undertaken at Washington University in recent years to determine rather more clinical problems were observed following total knee replacement with or without patella resurfacing. Records were maintained on all problem total knees cases with well localised anterior knee pain. The referral area for this clinic is St. Louis which is among the largest American cities, with the highest percentage of total knees that are performed without patella resurfacing. During 4 years of referrals of total knee patients with anterior knee pain, 47 cases were identified of which 36 had a resurfaced patella and 11 had a non-resurfaced patella. Eight of 36 resurfaced patellae underwent surgery while only 2 of 11 non-resurfaced patellae underwent subsequent surgery. More than 3 times as many painful total knees that were referred for evaluation had already had their patella resurfaced. In spite of the fact that approximately equal number of total knees were performed in this area without patella resurfacing, far more patients presented to clinic with painful total knee in which the patella had been resurfaced. The numerous pathologies requiring a treatment following patella resurfacing included patella loosening, fragmentation of the patella, avascular necrosis patella, late stress fracture, lateral facet pain, oblique resurfacing, and too thick of a patellar composite. In a large multi-center randomised clinical trial at 5 years from the United Kingdom in over 1700 knees from 34 centers and 116 surgeons, there was no difference in the Oxford Score, SF-12, EQ-5D, or need for further surgery or complications. The authors concluded, “We see no difference in any score, if there is a difference, it is too small to be of any clinical significance”. In a prospective of randomised clinical trial performed at Tulane University over 20 years ago, no differences were observed in knee score, a functional patella questionnaire, or the incidence of anterior knee pain between resurfaced and un-resurfaced patellae at time intervals of 2–4 years, 5–7 years, or greater than 10 years. Beyond 10 years the knee scores of total knee patients with a resurfaced patella had declined significantly greater than those with a non-resurfaced patella. There are numerous advantages of not resurfacing the patella including less surgical time, less expense, a lower risk of “major” complications (especially late complications), and if symptoms develop in an un-resurfaced patella, it is an easier salvage situation with more options available. A small percentage of total knee patients will be symptomatic whether or not their patella is resurfaced. Not resurfacing the patella retains more options and has fewer complications. The major determinant of clinical result and the presence of anterior knee pain after knee replacement is surgical technique and component design not whether or not the patella is resurfaced. Patella resurfacing is occasionally necessary for patients with inflammatory arthritis, a deformed or maltracking patella, or symptoms and pathology that are virtually restricted to the patellofemoral joint. For the vast majority of patients, however, patella resurfacing is not necessary

Resurfacing the patella is performed the majority of the time in the US and in many regions it is considered standard practice. In many countries, however, the patella is left unresurfaced an equal amount of the time or even rarely ever resurfaced. Patella resurfacing is not a simple or benign procedure. There are numerous negative sequelae of resurfacing including loosening, fragmentation, avascular necrosis, lateral facet pain, stress fracture, acute fracture, late fracture, and restricted motion. In a study by Berend, Ritter, et al, failures of the patella component were reported 4.2% of the time at an average of only 2.6 years. A study was undertaken at Washington University in recent years to determine whether more clinical problems were observed following total knee replacement with or without patella resurfacing. Records were maintained on all problem total knees cases with well localised anterior knee pain. The referral area for this clinic is St. Louis which is among the largest American cities, with the highest percentage of total knees that are performed without patella resurfacing. During 4 years of referrals of total knee patients with anterior knee pain, 47 cases were identified of which 36 had a resurfaced patella and 11 had a non-resurfaced patella. Eight of 36 resurfaced patellae underwent surgery while only 2 of 11 non-resurfaced patellae underwent subsequent surgery. More than 3 times as many painful total knees that were referred for evaluation had already had their patella resurfaced. In spite of the fact that approximately equal number of total knees were performed in this area without patella resurfacing, far more patients presented to clinic with painful total knee in which the patella had been resurfaced. The numerous pathologies requiring a treatment following patella resurfacing included patella loosening, fragmentation of the patella, avascular necrosis patella, late stress fracture, lateral facet pain, oblique resurfacing, and too thick of a patellar composite. In a large multi-center randomised clinical trial at 5 years from the United Kingdom in over 1700 knees from 34 centers and 116 surgeons, there was no difference in the Oxford Score, SF-12, EQ-5D, or need for further surgery or complications. The authors concluded, “We see no difference in any score, if there is a difference, it is too small to be of any clinical significance”. In a prospective randomised clinical trial performed at Tulane University over 20 years ago, no differences were observed in knee score, a functional patella questionnaire, or the incidence of anterior knee pain between resurfaced and unresurfaced patellae at time intervals of 2–4 years, 5–7 years, or greater than 10 years. Beyond 10 years the knee scores of total knee patients with a resurfaced patella had declined significantly greater than those with a non-resurfaced patella. There are numerous advantages of not resurfacing the patella including less surgical time, less expense, a lower risk of “major” complications (especially late complications), and if symptoms develop in an unresurfaced patella, it is an easier salvage situation with more options available. A small percentage of total knee patients will be symptomatic whether or not their patella is resurfaced. Not resurfacing the patella retains more options and has fewer complications. The major determinant of clinical result and the presence of anterior knee pain after knee replacement is surgical technique and component design not whether or not the patella is resurfaced. Patella resurfacing is occasionally necessary for patients with inflammatory arthritis, a deformed or maltracking patella, or symptoms and pathology that are virtually restricted to the patellofemoral joint. For the vast majority of patients, however, patella resurfacing is not necessary

Introduction and Aims: The dilemma to retain or sacrifice the posterior cruciate ligament in a primary total knee arthroplasty continues to be an area of discussion. A randomised clinical trial was performed comparing clinical, radiographic and quality of life outcomes between patients receiving a posterior cruciate sparing versus posterior cruciate substituting knee implants. Method: A multi-centred, prospective, randomised, blinded, clinical trial was performed to compare posterior cruciate retaining (CR) versus posterior cruciate substitution (PS) in osteoarthritic patients with an intact posterior cruciate ligament, undergoing total knee arthroplasty using the AMK. ®. (Depuy. ®. , Warsaw, Indiana) component. One hundred and fifty-two patients were randomised to receive one of the two devices. Patients were evaluated pre-operatively, at three, six, 12 months and annually thereafter. Patient demographics, radiographs, and multiple validated, outcome measures (WOMAC, SF-12, the Knee Society Clinical Rating System, and a stair climbing test) were evaluated. Patients and assessors were blinded to the implant design. Results: One hundred and fifty-two patients were randomised at three centres; 72 in the CR group and 80 in the PS group. One patient was revised due to instability. Average follow-up was 5.14 years (range 2.97–6.99 years). There were no significant differences in baseline patient demographics between groups. There were no significant differences in outcome measures or radiographic findings. There were no significant differences in the Knee Society Clinical Rating System (CR- 159.18 versus PS- 156.49). There were no differences in knee extension at latest follow-up (CR- 1.02) and (PS- 1.10). There were no differences in knee flexion at latest follow-up (CR-111.00 ) and (PS- 113.61). No differences were noted in the WOMAC and SF-12 scores between the two groups. Conclusion: In this prospective randomised clinical trial no significant differences involving radiographs and multiple outcome measures could be seen between a cruciate retaining versus a posterior stabilised total knee prostheses at a mean follow-up of 5.14 years. Long-term evaluation is necessary to comment on wear, osteolysis and implant longevity

We compared self-reported pain and function, complications and revision rates, and radiographic outcomes of hydroxylapatite(HA) or cemented tibial fixation in the first five years following primary total knee arthroplasty. This was a randomised clinical trial of eighty-one patients. Prospective, randomised clinical trial. Patients less than seventy years of age with non-inflammatory knee arthritis. Eighty-one patients were randomised at the time of surgery to receive HA or cemented tibial fixation. Subjects were evaluated preoperatively, six months, one and five years postoperatively by a physical therapist who was blinded to group allocation. X-rays were evaluated by an experienced arthroplasty surgeon who did not perform any of the surgeries. Self-reported pain and function, the primary outcomes, were measured by the Western Ontario McMaster (WOMAC) Osteoarthritis Index and the RAND 36-item Health Services Inventory (RAND-36). Complications and revision rates were determined through hospital record review and at each patient evaluation. The Knee Society Radiological Score was used to evaluate plain radiographs at each assessment. There was slightly more pain in HA group at six months as measured by both the WOMAC and RAND-36, a difference that disappeared by the one-year assessment. There were no differences in function, radiographic findings or complications at any time. Finally, no subjects required revision of the tibial prosthesis during the study. Overall, no significant differences were seen between groups. The initial difference in self-reported pain disappeared by twelve-months postoperatively. At five-years postoperatively, there is no advantage to HA tibial fixation over cemented tibial fixation

Durable humeral component fixation in shoulder arthroplasty is necessary to prevent painful aseptic loosening and resultant humeral bone loss. Causes of humeral component loosening include stem design and material, stem length and geometry, ingrowth vs. ongrowth surfaces, quality of bone available for fixation, glenoid polyethylene debris osteolysis, exclusion of articular particulate debris, joint stability, rotator cuff function, and patient activity levels. Fixation of the humeral component may be achieved by cement fixation either partial or complete and press-fit fixation. During the past two decades, uncemented humeral fixation has become more popular, especially with short stems and stemless press fit designs. Cemented humeral component fixation risks difficult and complicated revision surgery, stress shielding of the tuberosities and humeral shaft periprosthetic fractures at the junction of the stiff cemented stem and the remaining humeral shaft. Press fit fixation may minimise these cemented risks but has potential for stem loosening. A randomised clinical trial of 161 patients with cemented vs. press fit anatomic total shoulder replacements found that cemented fixation of the humeral component provided better quality of life, strength, and range of motion than uncemented fixation but longer operative times. Another study found increased humeral osteolysis (43%) associated with glenoid component loosening and polyethylene wear, while stress shielding was seen with well-fixed press fit humeral components. During reverse replacement the biomechanical forces are different on the humeral stem. Stem loosening during reverse replacement may have different factors than anatomic replacement. A systemic review of 41 reverse arthroplasty clinical studies compared the functional outcomes and complications of cemented and uncemented stems in approximately 1800 patients. There was no difference in the risk of stem loosening or revision between cemented and uncemented stems. Uncemented stems have at least equivalent clinical and radiographic outcomes compared with cemented stems during reverse shoulder arthroplasty. Durable humeral component fixation in shoulder arthroplasty is associated with fully cemented stems or well ingrown components that exclude potential synovial debris that may cause osteolysis

Over the past 30 years, cemented, cementless, and hybrid fixation options have been utilised with various total knee arthroplasty (TKA) implant systems. While cemented components are widely used and considered the most reliable method of fixation, historical results may not be applicable to contemporary patients, who are increasingly younger than 65 years of age. Moreover, the literature is not definitive on which method of TKA fixation obtains the best clinical, functional, and radiographic results. A recent Cochrane meta-analysis on roentgen stereophotogrammetric analysis (RSA) included five randomised clinical trials (RCTs) in 297 participants. The authors observed that cemented fixation of tibial components demonstrated smaller displacement in relation to cementless fixation. However, the risk of future aseptic loosening with uncemented fixation was approximately half that of cemented fixation (risk ratio = 0.47, 95% CI 0.24 to 0.92) with a 16% absolute risk difference between groups. Almost all included studies recorded functional measures of Knee Society and Hospital for Special Surgery knee scores, but the authors of each study found no significant difference between the groups. Recently, highly porous metals have become an attractive fixation option in TKA due to their biomechanical properties. In a large RCT of 397 patients, Pulido et al found that uncemented highly porous metal tibias provided comparably durable fixation and reliable pain relief and restoration of function when compared with traditional cemented modular tibias. While longer term studies are needed, cementless TKAs may be a durable and reliable alternative with highly porous metals, particularly in younger patients

Tranexamic acid (TXA) is an effective medication to limit blood loss and transfusion requirements in association with contemporary total joint arthroplasty. TXA is in a class of medications termed anti-fibrinolytics due to their action to limit the breakdown of clot that has already been formed. It is useful to note that TXA does not promote the formation of clot, it simply limits the breakdown of already established clot. A recent systematic review and meta-analysis of randomised clinical trials of TXA use in total hip replacement demonstrated: 1) a substantial reduction in the proportion of patients who required transfusion and 2) no increase in DVT or PE. Similarly a recent Cochrane Database systematic review assessed Anti-fibrinolytic Use for Minimizing Perioperative Blood Transfusion and found tranexamic acid to be effective in reducing blood loss during and after surgery and to be free of serious adverse effects. In orthopaedic surgery varying doses have been used over time. A pragmatic dosing approach for Total Knee and Total Hip patients has been used at the Mayo Clinic over the past 16 years: 1 gram IV over 10 minutes prior to incision (delivered at same time as pre-op antibiotics) followed by 1 gram IV over 10 minutes at the time wound closure is initiated. Infusion rates greater than 100 mg/minute have been associated with hypotension and thus the recommendation for 1 gram over 10 minutes. A recent review of 1500 TKA patients at Mayo Clinic revealed a very low prevalence of clinically symptomatic DVT and PE when tranexamic acid was used with 3 different thromboembolic prophylaxis regimens (aspirin and foot pumps; coumadin; low molecular weight heparin). The safety of TXA for patients with coronary stents has not been fully clarified

Aims. 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. Patients and Methods. 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. Results. OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. Conclusion. These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383–92

Total hip arthroplasty (THA) has been cited as one of the most successful surgical procedures performed today. However, as hip surgeons, we desire constantly improving outcomes for THA patients with more favorable complication rates. At the same time, patients desire hip pain relief and return to function with as little interruption of life as possible. The expectation of patients has changed; they have more physical demands for strength and flexibility, and aspire to achieve more in their recreational pursuits. Additionally, health care system constraints require the THA episode of care to become more efficient as the number of procedures increases with time. These factors, over the past fifteen years, have led to a search for improved surgical approaches and peri-operative pain and rehabilitation protocols for primary THA. The orthopaedic community has seen improved pain control, length of stay, and reduction in complications with changes in practice and protocols. However, the choice of surgical approach has provided significant controversy in the orthopaedic literature. In the 2000s, the mini-posterior approach (MPA) was demonstrated as the superior tissue sparing approach. More recently, there has been a suggestion that the direct anterior approach (DAA) leads to less muscle damage, and improved functional outcomes. A recent prospective randomised trial has shown a number of early deficits of the posterior approach when compared to the direct anterior approach. The posterior approach resulted in patients taking an additional 5 days to discontinue a walker, discontinue all gait aids, discontinue narcotics, ascend stairs with a gait aid, and to walk 6 blocks. Patients receiving the posterior approach required more morphine equivalents in the hospital, and had higher VAS pain scores in the hospital than the direct anterior approach. Interestingly, activity monitoring at two weeks post-operatively also favored DAA with posterior approach patients walking 1600 steps less per day than DAA patients. There has been little difference in the radiographic outcomes or complications between approaches in prospective randomised trials. A number of randomised clinical trials have demonstrated that both the direct anterior and posterior approach provided excellent early post-operative recovery with a low complication rate. DAA patients have objectively faster recovery with slightly shorter times to achieve milestones of function, with similar radiographic and clinical outcomes at longer-term outcomes, with a similar complication rate

Over the past 30 years, cemented, cementless, and hybrid fixation options have been utilised with various total knee arthroplasty (TKA) implant systems. While cemented components are widely used and considered the most reliable method of fixation, historical results may not be applicable to contemporary patients, who are increasingly younger than 65 years of age. Moreover, the literature is not definitive on which method of TKA fixation obtains the best clinical, functional, and radiographic results. A recent Cochrane meta-analysis on roentgen stereophotogrammetric analysis (RSA) included five randomised clinical trials (RCTs) in 297 participants. The authors observed that cemented fixation of tibial components demonstrated smaller displacement in relation to cementless fixation. However, the risk of future aseptic loosening with uncemented fixation was approximately half that of cemented fixation (risk ratio = 0.47, 95% CI 0.24 to 0.92) with a 16% absolute risk difference between groups. Almost all included studies recorded functional measures of Knee Society and Hospital for Special Surgery knee scores, but the authors of each study found no significant difference between the groups. Recently, highly porous metals have become an attractive fixation option in TKA due to their biomechanical properties. In a large RCT of 397 patients, Pulido et al found that uncemented highly porous metal tibias provided comparably durable fixation and reliable pain relief and restoration of function when compared with traditional cemented modular tibias. While longer-term studies are needed, cementless TKAs may be a durable and reliable alternative with highly porous metals, particularly in younger patients

Bearing surfaces in Total Hip Arthroplasty (THA) may affect implant longevity and hence patient outcomes. This randomised clinical trial (RCT) determined how ceramic-on-ceramic bearing (CERAMIC) THA affected joint-specific pain, function and stiffness, and prosthesis fixation/longevity over 10 postoperative years compared with ceramic-on-highly-crosslinked-polyethylene bearing (POLYETHYLENE) THA. This is a follow-up to previously reported five year outcomes. Subjects aged less than 61 years were randomised to CERAMIC [n=48] or POLYETHYLENE [n=44] THA. Subjects were assessed using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and the RAND 12-Item Health Survey (RAND-12) preoperatively, and at one, five and 10 years postoperatively. Plain radiographs were evaluated at 10 years for fixation and medical records were reviewed for revisions. Of 92 subjects, six (7%) died within 10 years; 68 (79%) survivors provided radiographic and/or clinical follow-up at 10 years postoperatively. Improvements seen at five years in both the WOMAC and RAND-12 were retained at 10 years with no group differences (p>0.48). There were no failures/loss of fixation related to bearing surfaces/wear in either group. Over 10 years, three subjects in the POLYETHYLENE group had revisions that were related to recurrent dislocation; two revisions were performed within two years of surgery and one further subject underwent revision at 7 years postoperatively. This is one of the first RCTs to examine 10 year outcomes between ceramic-on-ceramic and ceramic-on-highly-crosslinked-polyethylene bearing THA. Both bearing surfaces performed well out to 10 years in subjects who were less than 61 years at time of surgery

Tranexamic acid (TXA) is an effective medication to limit blood loss and transfusion requirements in association with contemporary total joint arthroplasty. TXA is in a class of medications termed anti-fibrinolytics due to their action to limit the breakdown of a clot that has already been formed. It is useful to note that TXA does not promote the formation of a clot, it simply limits the breakdown of already established clots. A recent systematic review and meta-analysis of randomised clinical trials of TXA use in total hip replacement demonstrated: 1) a substantial reduction in the proportion of patients who required transfusion and 2) no increase in DVT or PE. Similarly a recent Cochrane Database systematic review assessed Anti-fibrinolytic Use for Minimizing Perioperative Blood Transfusion and found tranexamic acid to be effective in reducing blood loss during and after surgery and to be free of serious adverse effects. In orthopaedic surgery, varying doses have been used over time. A pragmatic dosing approach for Total Knee and Total Hip patients has been used at the Mayo Clinic over the past 16 years: 1 gram IV over 10 minutes prior to incision (delivered at same time as pre-operative antibiotics) followed by 1 gram IV over 10 minutes at the time wound closure is initiated. Infusion rates greater than 100 mg/minute have been associated with hypotension and thus the recommendation for 1 gram over 10 minutes. A recent review of 1500 TKA patients at Mayo Clinic revealed a very low prevalence of clinically symptomatic DVT and PE when tranexamic acid was used with 3 different thromboembolic prophylaxis regimens (aspirin and foot pumps; coumadin; low molecular weight heparin). The safety of TXA for patients with coronary stents has not been fully clarified

Stereotactic principles used primarily for brain surgery have been developed further and introduced into spine surgery at the beginning of the 1990’s. The system solutions available consist of three components: the surgical object (vertebra), the virtual object (CT-image data of the vertebra), and the navigatorallowing the surgeon to localise the position of the instrument inside the surgical object in real-time. Optoelectronic systems using infrared light emitting diodes and magnetic field based navigators are in use. Lumbar pedicle screw insertion was the first clinical application for this technique. Screws can be positioned safely following a preplanned optimal trajectory or according to the anatomic situation utilising the real-time module intraoperatively. The effectiveness of this new technique has been shown in prospective studies (Schwarzenbach et al 1997, Laine et al 1997, 1999). In a a prospective randomised clinical trial one-hundred consecutive patients were randomly allocated for either conventional (Group 1) or computer assisted (Group 2) pedicle screw insertion. From the computer assisted group nine patients were dropped out. There was no statistical difference between the groups. CT-based optoelectronic navigation was used for screw insertion in Group 2. The screw position in the pedicle was assessed postoperatively by an independent observer with CT. The pedicle perforation rate was 13.4% (37/277 screws) in the conventional group and 4.6% (10/219 screws) in the computer assisted group (P=0.006). The majority of perforations was less than 4 mm. A pedicle perforation of 4 to 6 mm was found in 1.4% (4/277) of the screws in Group 1, and none in Group 2. Intraoperatively, eleven screws were repositioned in Group 1 and none in Group 2. There were no postoperative complications related to screw placement. We conclude that higher accuracy of pedicle screw insertion with computer assisted navigation than with conventional methods could be demonstrated under clinical conditions in a randomised controlled clinical trial. At present CAOS Systems are used also for localisation of intraosseous pathologic processes during biopsies in spine and pelvis, sacroiliac screw fixation and vertebral osteotomies. Refinement of the method for use in minimal invasive and percutaneous procedures is in progress