Tranexamic acid is an antifibrinolytic drug that has been shown to successfully reduce postoperative blood loss in total knee and hip arthroplasty. However, the efficacy of TXA following total shoulder arthroplasty has not been reported. The purpose of the present study was to evaluate the impact of intravenous TXA on postoperative blood loss and transfusion rates in total shoulder reconstruction.Background
Purpose
The aim of this study was to compare a single-incision minimally invasive (MI) posterior approach with a standard posterior approach in a double-blind prospective randomised controlled trial. A pilot study was carried out to assess the efficacy of the MI approach. Primary total hip replacements meeting the inclusion criteria were randomised to either the MI approach or the standard posterior approach. Patients were blinded to allocation. Patients were scored by a blinded physiotherapist pre-operatively, at Day 2, 2 weeks and 6 weeks. The primary outcome measure was function, assessed using the Oxford hip score, SF-12 questionnaire, Iowa score, 6-minute walk test and the number of walking aids required after 2 and 6 weeks post-operatively. Secondary outcomes were complication rates, patient satisfaction, soft tissue trauma and radiographic analysis.Aim
Method
Prosthetic joint infection (PJI) is a much feared complication to arthroplasty with significant patient morbidity. Rifampin is increasingly used in staphylococcal PJIs treated with debridement and retention of the prosthesis. The evidence supporting rifampin combination therapy in PJIs is limited due to the lack of controlled studies. The aim of this study is to evaluate the effect of adding rifampin to conventional antimicrobial therapy in early staphylococcal PJIs treated with debridement and retention. In this multicentre randomized controlled trial, 99 patients with PJI after hip and knee arthroplasties were enrolled. All patients underwent a standardized surgical debridement. 65 patients had PJI caused by staphylococci and further included in the study. They were randomly assigned to receive rifampin or not in addition to standard antimicrobial therapy with cloxacillin, or vancomycin in case of methicillin resistance. They received parenteral antibiotics for two weeks, then oral antibiotics for 4 weeks. In case of methicillin resistance, vancomycin was administered i.v. for 6 weeks. The primary end point was no signs of infection after 2 wears follow-up.Aim
Method
We present a prospective, randomised, single-centre, multi-surgeon, controlled trial comparing minimally invasive (MIS) and standard approach total knee arthroplasty (TKA). 86 patients undergoing 92 total knee replacements were recruited. 46 operations were randomised to the MIS treatment arm, 46 to the standard control arm. Data collected included postoperative blood loss, length of stay and complications. Patients underwent surgery via a quadriceps sparing or standard medial parapatella approach. All operations were performed using MIS instruments and an identical postoperative care pathway. The MIS group had a significantly shorter length of stay (1.4 days, p=0.004) and fewer complications (p=0.003). Demographics, operative time blood loss and radiographic alignment were comparable between the groups. There were no deaths, pulmonary emboli or surgical site infections. 1 patient developed DVT and 1 required revision for pain and failure to regain flexion within 9 months of surgery, both in the control group. Nine percent of MIS patients versus 35% controls suffered a complication delaying discharge, of which 2% and 17% related to surgical site problems respectively. MIS resulted in a shorter admission and fewer complications, whilst achieving satisfactory component alignment. We discuss the potential economic implications.
Recently many authors have questioned the role of tourniquets in primary knee arthroplasty (TKA). Meanwhile, whether the use of an intra-articular wound drainage is an advance over the lack of a drain in TKA is controversial in the literature. This study aimed to investigate the efficacy and safety of drainage or not in TKA without a tourniquet. Eighty participants who underwent primary unilateral TKA were prospectively enrolled and were randomized to one of two techniques during surgery without a tourniquet: drainage (Group A) or non-drainage (Group B). Blood loss was monitored perioperatively. The operating time, allogeneic blood transfusion rate, thigh pain, knee pain, limb swelling, clinical outcome as measured by the hospital for special surgery (HSS) score, the ability to straight-leg raise, visual analog scale (VAS) in pain, length of stay and knee active range of motion (ROM) were also recorded. The digital radiographs taken at 6 months postoperatively were assessed for cement mantle thickness and radiolucency using the Knee Society radiographic zones.Purpose
Methods
Ischaemia reperfusion injury (IRI) is a very common metabolic insult in orthopaedics. It is often a subtle clinical event such as after brief tourniquet use, however severe injury, even multi-organ failure or death may result from prolonged tourniquet-use, crush injuries, vascular trauma or the release of compartment-syndrome. IRI is mediated by leukocyte infiltration and oxidatively-induced endothelial disruption. Antioxidants clearly attenuate or prevent this effect in animal models. That the antioxidant medications ascorbate and n-acetyl-cysteine attenuate IRI in the setting of elective knee arthroscopy.Introduction
Hypothesis
Shoulder pain represents a significant burden of disease in the general population, yet there is a lack of evidence about the effectiveness of routinely used interventions. Current management of ‘painful arc’ of the shoulder in Primary Care is not evidence-based. Over a six-month period patients with ‘painful arc’ of less than six months duration were recruited via their GPs. Eligible patients were consented to enter the trial and were then randomised, by sealed envelopes, to one of four arms of the study: control (normal analgesia and/or non-steroidal anti-inflammatory medication), a specified and repeatable Exercise and Manual Therapy Package (EMTP), a course of up to three subacromial steroid injections or both the EMTP and the steroid injections. The interventions and clinic follow-ups were over an 18-week period. A final postal questionnaire was sent out at one year. The progress of the patients was monitored using the Oxford Shoulder Score (OSS) and the SF36 general health questionnaire. Seventy-nine GPs referred 186 patients, of whom 112 were randomised (Control=27, EMTP=29, Injections=28, Both=28). 64 patients were female and 48 male. The mean age was 54.5 years (range 23-88 years). Ninety patients completed the trial (Control=20, EMTP=22, Injections=26, Both=22). Sixty-two returned the follow-up questionnaire. By paired sample t-tests, no significant differences were found between the OSS scores or SF-36 (physical health total) at the beginning and end of the intervention period, or at one year, in any group. There were no differences in changes in scores between groups. Two patients in the injection group went on to surgery, along with one each in the control and EMTP groups. We have found no significant differences in outcome between steroid injections, a physiotherapy package, both treatments, or symptomatic treatment in our group of patients presenting with symptoms of painful arc of the shoulder.
Athletes involved in repetitive overhead shoulder rotation demonstrate increased external rotation and decreased internal rotation range of motion. Deficits in internal rotation have been linked to the development of shoulder pathology. The purpose of this study is to determine if a posterior shoulder stretch program is effective in increasing dominant arm internal rotation and horizontal adduction range of motion in overhead athletes identified as having reduced mobility and posterior shoulder tightness. Thirty-seven overhead athletes in volleyball, swimming and tennis, with internal rotation range of motion deficits greater than or equal to 15°, were randomised into intervention or control groups. The intervention group performed the “sleeper stretch” daily for eight weeks while the control group performed usual activities. Independent t-tests determined whether internal rotation and horizontal adduction range of motion differences between groups were significant and two-way repeated measures analysis of variance tests measured the rate of shoulder range of motion change. Reported shoulder pain and function were also obtained at each evaluation. Significant differences were found between the intervention and control groups' internal rotation and horizontal adduction range of motion at eight weeks (p<0.001 and p=0.003 respectively) compared to baseline (zero weeks) (p=0.19 and p=0.82 respectively). Significant changes in internal rotation were detected in the intervention group at four weeks (p<0.001) with further adaptations noted at eight weeks. Horizontal adduction improved at a slower rate demonstrating significant changes at eight weeks (p=0.003). Reported shoulder pain and functional ability (p=0.002) were different between the study groups at eight weeks. Overhead, collegiate-level athletes with an internal rotation deficit greater than or equal to 15° are able to significantly increase internal rotation and horizontal adduction range of motion by performing a posterior shoulder stretch exercise for eight weeks.
Total knee arthroplasty is a painful operation. Peri-articular local anesthetic injections reduce post-operative pain and assist recovery. It is inconclusive whether intra-operative injections of peri-articular corticosteroids are of benefit. A prospective, randomized, double-blinded study was undertaken to assess the efficacy of adding peri-articular corticosteroids to intra-operative, peri-articular high volume local anaesthetic in post-operative pain management following TKA. 127 patients were randomised into three groups receiving local anaesthetic alone (control) or either low dose (40 mg) or high dose (80 mg) peri-articular corticosteroid plus local anaesthetic. Primary outcomes included ROM and visual analog pain scores (VAS). Pain was defined as the worst pain lasting for more than 20 minutes, measured at both rest (RVAS) and during activity (AVAS).Introduction
Methods
We conducted a randomized controlled trial (RCT) to investigate if iodine impregnated incision drapes (IIID) increases bacterial recolonization rates compared to no drape use under conditions of simulated total knee arthroplasty (TKA) surgery. Background: To prevent surgical site infection (SSI), one of the important issues is managing the patient´s own skin flora. Many prophylactic initiatives have been suggested, including the use of IIID. IIID has been debated for many years and was deemed ineffective in preventing SSI in a recent systematic review [1], while some evidence suggests a potential increase in postoperative infection risk, as a result of IIID use [2]. IIID is sparsely investigated in orthopaedic surgery. An increase in the number of viable bacteria in the surgical field of an arthroplasty operation has a potential to increase the risk of SSI in an otherwise elective and clean procedure [3]. 20 patients scheduled for TKA were recruited. Each patient had one knee randomized for draping with IIID [4] while the contralateral knee was left bare, thus the patients acted as their own controls. Operating theater settings with laminar airflow and standard perioperative procedures were simulated. Sampling was performed with the cup-scrup technique [5] using appropriate neutralizers. Samples were collected from the skin of each knee prior to disinfection and on 2 occasions after skin-preparation, 75 minutes apart. Bacterial quantities were estimated by spread plating with 48-hour aerobic incubation. Outcome was measured as colony forming units per square centimeter of skin. We used Wilcoxon signed-rank test for comparative analysis within and between knees. Following skin-disinfection we found no significant difference in bacterial quantities between the intervention and the control knee (p = 0.388). Neither did we see any difference in bacterial quantities between the two groups after 75 minutes of simulated surgery (p = 0.367). When analyzed within the intervention and control group, bacterial quantities had not significantly increased at the end of surgery when compared to baseline, thus no recolonization was detected (p = 0.665 and 0.609, respectively). Iodine impregnated incision drapes did not increase bacterial recolonization rates in simulated TKA surgery. Thus, the results of this RCT study does not support the hypothesis that iodine impregnated incision drapes promotes bacterial recolonization and postoperative infection risk.
In a prospective randomised controlled trial, 51 patients who did not receive a bone plug during total knee replacement surgery were compared to 49 patients who received a bone plug. The primary outcome measure was the need for allogenic blood transfusion requirement and the secondary outcome was the post-operative blood loss and decline in haemoglobin levels. The patients had autologous re-transfusion from their closed drainage system. The two groups did not differ in the demographics. The mean intra-operative blood loss was slightly more in the no plug group (difference of 41.25 millilitres), which was not statistically significant. There was no statistically significant difference in total post-operative blood loss and drop in haemoglobin levels. Only one patient had two units of allogenic blood transfusion in the no bone plug group while none required allogenic blood in the bone plug group. There was no statistically significant difference in the amount of blood re-transfused from the drain between the two groups. Our findings did not show any statistically significant difference in post-operative blood loss, decline in haemoglobin levels and the need for allogenic blood transfusion in total knee replacement surgery.
Acute achilles tendon ruptures are increasing in incidence and occur in 18 per 100 000 people per year, however there remains a lack of consensus on the best treatment of acute ruptures. Randomised studies comparing operative versus non-operative treatment show operative treatment to have a significantly lower re-rupture rate, but these studies have generally used non-weight bearing casts in the non-operative group. Recent series utilizing more aggressive non-operative protocols with early weight-bearing have noted a far lower incidence of re-rupture, with rates approaching those of operative management. Weight bearing casts may also have the advantages of convenience and an earlier return to work, and the purpose of this study was to compare outcomes of traditional casts versus Bohler-iron equipped weight-bearing casts in the treatment of acute Achilles tendon ruptures. 83 patients with acute Achilles tendon ruptures were recruited from three Auckland centres over a 2 year period. Patients were randomised within one week of injury to receive either a weight-bearing cast with a Bohler iron or a traditional non weight-bearing cast. A set treatment protocol was used, with a total cast time of eight weeks. Patients underwent detailed muscle dynamometry testing at 6 months, with further follow up at 1 year and at study completion. Primary outcomes assessed were patient satisfaction, time to return to work, and overall re-rupture rates. Secondary outcomes included return to sports, ankle pain and stiffness, footwear restrictions, and patient satisfaction. There were no significant differences in patient demographics or activity levels prior to treatment. At follow up, 1 patient (2%) in the Bohler iron group and 2 patients (5%) in the non weight bearing group sustained re-ruptures (p=0.62). There was a trend toward an earlier return to work in the weight-bearing group, with 58% versus 43% returning to work within 4 weeks, but the difference was not significant. 63% of patients in the weight bearing group reported freedom from pain at 12 months compared to 51 % in the non weight bearing group. There were no statistically significant differences in Leppilahti scores, patient satisfaction, or return to sports between groups. Weight-bearing casts in the non-operative treatment of Achilles tendon ruptures appear to offer outcomes that are at least equivalent to outcomes of non-weight bearing casts. The overall rerupture rate in this study is low, supporting the continued use of initial non-operative management in the treatment of acute ruptures.
Thoracic kyphosis increases with age. The resultant increase in compression forces on the anterior vertebral bodies leads to further kyphotic deformity and, an increased likelihood of vertebral collapse. This study aimed to determine the relative efficacy of two therapeutic strategies commonly used to treat hyperkyphosis. 69 subjects (26 male: 43 female) were randomised into 4 groups: strengthening, postural re-education (PEd), both and control. The strengthening group attended a gym 3 times a week for 12 weeks to perform seated extension exercises. The PEd group had 3 physiotherapy sessions within a 12 week period in which they received postural assessment and a home exercise programme. The combined group received both interventions while the control group received neither. Outcome measurements were assessed at baseline and 12 weeks. They included static (inclinometer) and 6-hour angular measurements (using flexible electrogoniometer (FEG)) and physical function tests. There were no significant differences between the marginal means of the angular measurements for any of the intervention groups. However, the group which received both interventions demonstrated reduced kyphosis as measured by the FEG angles (apex of the curve between T3 and T11), while the strengthening group showed reduced inclinometer angles (between T1 and T12). The strengthening group showed improvement in back extensor strength (BES) (0.6 +/− 0.2 N/kg, p < 0.01), time to walk 10 metres (−0.3 +/− 0.6 s, p < 0.05), and time to stand and sit 5 times (−0.9 +/− 0.6 s, p < 0.05). However, there was no relationship between change in BES and change in kyphotic angle. The PEd group showed the greatest improvement in the timed up and go test but this was not significant. Improvement in inclinometer angle over the 12 weeks was associated with degree of kyphosis at baseline (upright inclinometer r = −0.47, p=0.0001) but this relationship was not apparent in the FEG measurements. Both the FEG and inclinometer angles showed a marked decrease in degree of improvement in subjects aged >70. (50/50). A combination of strengthening and PEd was most effective at reducing hyperkyphosis. BES was improved with resisted strengthening but not with home-based postural exercises. However, increased BES was not associated with decreased kyphosis. Larger baseline kyphosis was associated with greater angular improvement. Subjects aged >70 were less likely to improve.
This prospective randomised controlled trial aims to compare the clinical and radiological outcomes of ceramic on ceramic, cobalt chrome on ultra-high molecular weight polyethylene, and cobalt chrome on highly cross-linked polyethylene bearing surfaces at a minimum of five years. One hundred and two primary total hip replacements were performed in ninety one patients between February 2003 and March 2005. All patients were younger than 65 (mean 52.7, 19–64). They were randomised to receive one of the three bearing surfaces. All patients had 28mm articulations with a Reflection uncemented acetabular component and a Synergy stem (Smith & Nephew, Memphis, Tennessee). Patients were followed up periodically up to at least sixty months following surgery. Outcome measures included WOMAC and SF12 scores. Radiological assessment included implant position, evidence of osteolysis and measurement of linear wear.Purpose
Method
Economic evaluation alongside a prospective, randomised, controlled trial from a two-year National Health Service (NHS) perspective. To determine the cost-effectiveness of Titanium Cages (TC) compared to Femoral Ring Allografts (FRA) in circumferential lumbar spinal fusion.Study design
Objective
Fifty thousand knee replacements are performed annually in the UK at an estimated cost of £150 million. However, there is uncertainty as to the best surgical approach to the knee joint for knee arthroplasty. We undertook a randomised controlled trial to compare a standard medial parapatellar arthrotomy with sub-vastus arthrotomy for patients undergoing primary total knee arthroplasty in terms of short and long term knee function. Two hundred and thirty-one patients undergoing primary total knee arthroplasty during 2001-2003 were recruited into the study. Patients were randomised into subvastus (116) or medial parapatellar (115) approaches to knee arthroplasty. The primary outcome measures were the American Knee Society and WOMAC Scores. The secondary outcome measures were patient-based measures of EuroQol and SF-36. All outcomes were measured pre-operatively and 1, 6, 12 and 52 weeks post-operatively. We also looked at a pain diary, analgesia diary, ease of surgical exposure, and complications.Introduction
Methods
Estimated to affect 2–5% of the population, adhesive capsulitis is a common cause of shoulder pain and dysfunction. The objective of this study is to determine if arthrographic injection of the shoulder joint with steroid, local anesthetic and contrast is an effective treatment modality for adhesive capsulitis and whether it is superior to arthrographic injection with local anesthetic and contrast alone. This is a double-blinded RCT of patients with a diagnosis of adhesive capsulitis who were randomly assigned to receive an image guided arthrographic glenohumeral injection with either triamcinalone (steroid), lidocaine (local anesthetic) and contrast or lidocaine and contrast alone. Outcome measures included active and passive shoulder range of motion (ROM) and functional outcomes assessed using the Shoulder Pain and Disability Index (SPADI), the Constant Score and a Visual Analog Scale for pain. Post-operative evaluation occurred at 3 weeks, 6 weeks and 12 weeks. Descriptive statistics were utilised to summarise patient demographics and other study parameters. One-way ANOVAs compared the VAS, Constant and SPADI scores across the different time points for both study groups. The post hoc Bonferroni correction was used to adjust for multiple comparisons. There were 37 shoulders injected with follow-up visits at 12 weeks. Twenty shoulders were randomised to receive local plus steroid and 17 shoulders received local anesthetic only. There were 21 females and 14 males with an average age of 54 years (range, 42–70). VAS scores for both patient groups were significantly improved (p<0.05) at all follow-up times. Goniometric testing demonstrated significant improvements in forward flexion and internal rotation at 90 degrees in the local group and only abduction in the local plus steroid group. There were no significant changes in the Constant scores for the local group (p=0.08), however, the Constant scores showed significant improvement for the local plus steroid group (p=0.003) at all follow-up time points. The local group showed significant improvement in their SPADI pain scores at the 12 week follow-up only (p=0.01). There were no significant differences in their SPADI disability scores (p=0.09). The local plus steroid group had significant improvement in SPADI pain and disability scores at all follow-up time points (p=0.001). The optimal treatment for adhesive capsulitis remains unclear. Our study demonstrated that patients receiving an arthrographic injection of either steroid and local anesthetic or local anesthetic alone had significantly improved post-injection pain scores. However, only the steroid and local anesthetic group demonstrated improved SPADI disability and Constant scores. Thus, we believe that either treatment may be a good option for patients with adhesive capsulitis and can reliably relieve pain, but we would recommend the steroid with local anesthetic over the local anesthetic alone as it may provide improved function.
Current standard of care in the management of bone and joint infection commonly includes a 4–6 week course of intravenous (IV) antibiotics but there is little evidence to suggest that oral antibiotic therapy results in worse outcomes. The primary objective was to determine whether oral antibiotics are non-inferior to IV antibiotics in this setting. This was a parallel group, randomised (1:1), open label, non-inferiority trial across twenty-six NHS hospitals in the United Kingdom. Eligible patients were adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least six weeks of antibiotics and who had received ≤7 days of IV therapy from the date of definitive surgery (or the start of planned curative treatment in patients managed non-operatively). Participants were randomised to receive either oral or IV antibiotics for the first 6 weeks of therapy. Follow-on oral therapy was permitted in either arm. The primary outcome was the proportion of participants experiencing definitive treatment failure within one year of randomisation. The non-inferiority margin was set at 7.5%.Aim
Method
Evidence from recent trials has supported the efficacy of periarticular analgesic injection for pain control following total knee arthroplasty (TKA). However, no randomized controlled trial has compared the efficacy of periarticular analgesic injection with that of other regimens for simultaneous bilateral TKA. We conducted a randomized controlled trial in which patients scheduled for simultaneous bilateral TKA were randomly assigned to receive periarticular analgesic injection or epidural analgesia. In the periarticular analgesic injection group, the injection contained 7.5 mg/ml ropivacaine 40 ml, 10 mg/ml morphine hydrochloride hydrate 1.0 ml, 1.0 mg/ml epinephrine 0.6 ml, methylprednisolone 80 mg, and ketoprofen 50 mg. These agents were mixed with normal saline to a combined volume of 120 ml. The 60 ml of the cocktail was injected into each knee. In the epidural analgesia group, the catheter was placed at the L2–3 or L3–4 level, and connected to an infusion pump delivering continuous infusion (flow rate: 4 ml/h) of 100 ml of 2 mg/ml ropivacaine plus 1.0 ml of 10 mg/ml morphine hydrochloride hydrate. Surgery was managed under spinal anaesthesia. Surgical techniques and postoperative medication protocols were identical in both groups. The primary endpoint was postoperative pain at rest, quantified as the area under the curve (AUC) of the score on a visual analogue scale.Background
Methods
Although tourniquets are widely used in total knee arthroplasty (TKA), their influence on the postoperative course is still unclear. In addition, tourniquet-related soft tissue damage is a major concern in daily practice. We performed a prospective, randomized controlled trial to clarify the role of tourniquets in TKA. Seventy-two patients undergoing TKA were randomly allocated to a tourniquet or non-tourniquet group. Changes in C-reactive protein, creatine phosphokinase, and other indicators of soft tissue damage were monitored preoperatively and postoperatively on days 1, 2, and 4. Rehabilitation progress was also recorded for comparison.Background
Methods