INTRODUCTION: CTS is the most common nerve entrapment syndrome. Repeated flexion and extension activities of the wrist coupled with certain finger flexion causes oedema and compression of the median nerve within the carpal tunnel of the wrist. Several treatment options, both conservative and surgical are available to relieve the pressure on the median nerve. Although studies support the efficacy of splinting for CTS the length of splinting, type of splints, day or night use and the effects on other variables are still less agreed. MATERIALS AND METHODS: A
Prospective
The use of spinal anesthesia with adjuvant intra-thecal opioids has been commonly used in total knee arthroplasty without documented clinical benefit. It has been associated with a potential increase in side effects, including nausea, vomiting, pruritus, urinary retention and oxygen usage. This double-blinded RCT investigated whether the addition of epimorph to spinal anesthesia in patients undergoing total knee arthroplasty resulted in superior pain control and decreased narcotic consumption without also causing an increase in postoperative complication rates. We performed a prospective double-blind trial in patients undergoing primary total knee arthroplasty (TKA). Patients were randomised to receive either spinal anesthesia alone or spinal anesthesia with epimorph (150 ug). All patients received infiltration of a local anesthetic cocktail intraoperatively. Both the study patients and staff measuring outcomes were blinded to the experimental treatment received during data collection. Postoperatively, visual analogue scale (VAS) for pain was recorded at 6, 12, 18, 24, 36 and 48hrs and a final value at 1 week. Narcotic use, Foley insertion, oxygen requirements, nausea, vomiting and pruritus were recorded during the course of hospitalisation. Forty-one patients were randomised into each of the spinal with epimorph and spinal alone treatment arms. The groups showed no significant differences in BMI, age, and gender distribution. In the first 12 hours postoperatively there was no difference in VAS for pain between the two groups, however there were significantly lower pain scores in the spinal alone patients at 18 hours (p=0.002), 24 hours (p=0.04) and 48 hours (p = 0.03) compared to the spinal with epimorph group. Narcotic usage was greater in the spinal group during the first 6 hours postoperatively, but beyond this time point narcotic usage was similar between the two groups. Additionally, there was a statistically significant increase in rate of complications with spinal epimorph including nausea (p=0.037) and pruritus (p=0.024). The incidence of urinary retention was greater in the spinal epimorph group, however this did not reach statistical significance. This study demonstrates no clinical benefit with the addition of intra-thecal opioids to spinal anesthetic in primary TKA. In addition to a failing to reduce VAS pain scores and overall narcotic consumption, increased complication rates were seen. For these reasons, this study does not support the use of epimorph in addition to spinal anesthesia for pain control in TKA.
We performed two independent, randomised, controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis. The first trial, on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair. Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen. The second trial, on conservatively-treated patients, provided no evidence of a functional benefit from immediate weight-bearing mobilisation. However, the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate. In particular, there was no evidence of tendon lengthening or a higher re-rupture rate. We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis.
To assess the accuracy of posterior and anterolateral methods of injection into the subacromial space (SAS) of the shoulder. Ethical approval was obtained and 50 patients (23 women and 27 men) with mean age of 64.5 years (42-87 years) and clinical diagnosis of subacromial impingement were recruited. Patients with old or recent shoulder fracture, bleeding disorders, and allergy to iodine were excluded. All injections were given by the consultant or an experienced registrar after obtaining informed consent. Patients were randomised into posterior and anterolateral groups and the method of injection was revealed by opening sealed envelopes just before the injection. A combination of 3mls 0.5% bupivacaine and 2mls of radiographic dye (Niopam) was injected in the subacromial space (SAS) using either anterolateral (n-22) and posterior approaches (28). AP and lateral radiographs of shoulder were taken after injection and were reported by a Consultant Radiologist blinded to the method of injection. Visual analogue scale (VAS) and Constant-Murley shoulder score was used to assess pain and function respectively. Both scores were determined before and 30 minutes after the injection.Aims
Patients and methods
Knee flexion is often decreased in severe arthritis causing pain, and functional limitations in lifestyles and occupations. Newer knee replacement designs offer the possibility of greater knee motion. The objective of our study was to compare the clinical outcomes, in particular the range of motion, in patients treated with a total knee arthroplasty using either a standard posterior stabilized knee prosthesis or a high flexion posterior stabilized knee prosthesis, with regard to return to function within 1 year of surgery. This was a prospective randomized single blinded study. Forty patients were randomly assigned to receive either a standard fixed bearing posterior stabilized or a modified high flexion fixed bearing posterior stabilized Smith &
Nephew Genesis II total knee joint replacement. Clinical outcomes were determined from data collected on all patients who were evaluated pre-operatively, at twelve weeks post-operatively, and at one year post-operatively. Data collected included SF-12, WOMAC, and Oxford knee scores, and knee range of motion measurements. 37 of 40 patients enrolled completed the study. 22 patients were randomized to receive a standard posterior stabilized fixed bearing Genesis II knee replacement and 22 were randomized to receive a Hi-Flex posterior stabilized fixed bearing knee replacement. ROM, quality of life, and clinical scores at 12 months will be presented.
This multi-centre single-blind randomised control trial compared outcomes in patients with acute displaced mid-shaft clavicle fractures treated either by primary open reduction and plate fixation (ORPF), or non-operative treatment (NT). Two-hundred patients were randomised to receive either ORPF or NT. Functional assessment was conducted up to one-year using DASH, SF-12 and Constant scores (CS). Union was evaluated using radiographs and CT. Rate of non-union was significantly reduced after ORPF (1 following ORPF, 16 following NT, odds ratio=0.07, 95% CI=0.01–0.50, p=0.0006). 7 patients had delayed-union after NT. Group allocation to ORPF was independently predictive of development of non-union. DASH and CS were significantly better in the ORPF group 3-months post-surgery, but not at one-year (mean DASH = 6.2 after NT versus 3.7 after ORPF, p=0.09; mean CS = 86.1 after NT versus 90.7 after ORPF, p=0.05). Group allocation was not predictive of one-year outcome. Non-union was the only factor independently predictive of one-year functional outcome. There were no significant differences in time off work or subjective scores. Five patients underwent revision for complications after ORPF. 10 patients underwent metalwork removal. Treatment cost was significantly greater after ORPF (p=0.001). ORPF reduces rate of non-union compared with NT and is associated with better early functional outcomes. Improved outcomes are not sustained at one-year. Differences in functional outcome appear to be mediated by prevention of non-union from ORPF. ORPF is more expensive and associated with implant-related complications not seen with NT. Our results do not support routine primary ORPF for displaced mid-shaft clavicle fractures.
A recent multicentre randomized control trial (RCT) failed to demonstrate superior quality of life at one year following open reduction and internal fixation (ORIF) compared to nonoperative treatment for unstable isolated fibular fractures. We sought to determine the cost-effectiveness of ORIF compared to non-operative management of unstable fibular fractures. A decision tree was used to model the results of a multicentre trial comparing ORIF versus nonoperative treatment for isolated fibular fractures. A single payer, governmental perspective was used for the analysis. Utilities (a measure of preference for a health state) were obtained from the subjects Short-Form-6D scores and used to calculated Quality Adjusted Life Years (QALYs). Probabilities for each strategy were taken from the one-year trial endpoint. Costs were obtained from the Ontario Case Costing Initiative. Sensitivity analysis was performed for all model variables to determine when ORIF is a cost-effective treatment (incremental cost per QALY gained < $75,000).Purpose
Method
Primary mechanical stability is important with uncemented THR because early migration is reduced, leading to more rapid osseointegration between the implant and bone. Such primary mechanical stability is provided by the design features of the device. The aim of this study was to compare the migration patterns of two uncemented hip stems, the Furlong Active and the Furlong HAC stem; the study was designed as a randomised control trial. The implants were the Furlong HAC, which is an established implant with good long term results, and the Furlong Active, which is a modified version of the Furlong HAC designed to minimise stress concentrations between the implant and bone, and thus to improve fixation. The migration of 43 uncemented femoral components for total hip replacement was measured in a randomised control trial using Roentgen Stereophotogrammetric Analysis (RSA) over two years. Twenty-three Furlong HAC and twenty Furlong Active stems were implanted into 43 patients. RSA examinations were carried out post-operatively, and at six months, 12 months and 24 months post-operatively. The patients stood in-front of a purpose made calibration frame which contained accurately positioned radio-opaque markers. From the obtained images, the 3-D positions of the prosthesis and the host bone were reconstructed. Geometrical algorithms were used to identify the components of the implant. These algorithms allowed the femoral component to be studied without the need to attach markers to the prosthesis. The migration was calculated relative to the femoral coordinate system representing the anterior-posterior (A-P), medial-lateral (M-L) and proximal-distal (P-D) directions respectively. Distal migration was termed subsidence.Introduction
Materials and methods
Quadriceps femoris muscle weakness has long been associated with disuse atrophy in symptomatic knee osteoarthritis but more recently implicated in the aetiology of this condition. The purpose of this study was to assess the benefits of two interventions aimed at increasing quadriceps strength in subjects with moderate to severe knee osteoarthritis. Twenty-eight patients, aged fifty-five to seventy-five, were recruited and randomised to either a six-week home resistance-training exercise program or a six-week neuromuscular electrical stimulation (NMES) program. Eleven patients matched for age, gender and osteoarthritis severity formed a control group, receiving standard care. The resistance-training group performed six exercises three times per week, while the NMES group used the garment stimulator for twenty minutes five times per week Outcome measures included isometric and isokinetic quadriceps strength, functional capacity, quadriceps cross-sectional area, and validated health survey scores. These measures were assessed at baseline, post-intervention and at 6-weeks post-intervention. Both intervention groups showed significant improvements in all functional tests, in the global health survey, and in quadriceps cross-sectional area immediately post-intervention. An increase in isokinetic strength was seen in the exercise group only. With the exception of isokinetic strength, all benefits were maintained six weeks post-intervention. Both a six-week home resistance-training program and a six-week NMES program produce significant improvements in functional performance as well as physical and mental health for patients with moderate to severe knee osteoarthritis. Home-based NMES is an acceptable alternative to physical therapy, and is especially appropriate for patients who have difficulty complying with an exercise program.
Despite evidence of long term survival of cemented femoral stem prostheses, studies have shown concerns in the longevity of the cemented sockets. This has led to a rise in the use of uncemented and hybrid implants (with uncemented cup and cemented stem) without long term studies to determine evidence for their use. We aimed to assess whether there is any difference in clinical outcome between cemented and non-cemented acetabular fixation in elderly patients. Between February 2001 and August 2006 186 patients over 72 years of age were prospectively randomised to receive either a cemented Exeter cup or a HA coated press fit cementless cup. Both groups received a cemented Exeter stem. The patients were assessed pre-operatively and reviewed at 6 weeks, 6 months and yearly in a research clinic, by an independent observer. Outcome measures were the Merle D'Aubigné, Postel, Oxford Hip and Visual analogue pain scores. The implants were also assessed radiographically and all complications were recorded.Introduction
Patients and Methods
Osseous first ray surgery is a common day case procedure. Patients are often given regional blocks. We sought to find if there is a difference between ankle block and metatarsal block in this group of patients. After ethical approval was granted and power analysis performed, 25 patients were recruited into each arm of the study. These patients were having either an osteotomy or arthrodesis. All patients had standardised general anaesthesia and received 20mls of 0.5% chirocaine for the blockade. The cohort having the ankle block had infiltration under ultrasound guidance in the anaesthetic room; and the cohort receiving the metatarsal block had infiltration at the end of the procedure. The timings of both the anaesthesia and the operation were recorded for each patient. Patients scored their pain level at 2, 6 and 24 hours. The amount of post-operative analgesia used in the first 24 hours was also recorded by the research nurse. All patients were discharged home with a standardised prescription of analgesia. Analysis of the pain scores showed that there was no difference between the two blocks at any measured time period. Nor was there a difference in the analgesic requirement in the first 24 hours. There was, however, a difference in the time taken for the whole procedure: with the ankle block taking an average of ten minutes more. We conclude that metatarsal blocks are as effective as ankle blocks in providing pain relief after osseous first ray surgery, and may be a more efficient use of time.
Absorbable cement restrictors have been in use over the last few years. They have been shown to be as effective as the standard non-absorbable cement restrictors in achieving cement pressurisation and stopping distal cement migration in in vitro studies. The aim of this study is to compare in vivo, the effectiveness of absorbable with non-absorbable cement restrictors. One hundred and thirty-six consecutive patients who had total hip replacement performed using charnley cemented femoral prosthesis were selected and randomly divided in to two groups pre operatively. One group received Hardinge TM non-absorbable cement restrictor and the second group received Biostop TM absorbable cement restrictor. Type of the prosthesis, the surgical approach, the time from start of mixing of the cement to insertion of the cement (measure of viscosity of the cement), the cementing technique and the distance at which the cement restrictor was inserted were noted intraoperatively, the canal diameter was measured from the preoperative AP radiograph of the hip. The distance at which the cement restrictor was inserted was measured on the AP radiograph of the hip taken twenty-four hours postoperatively. All the above factors were statistically assessed as to their effect in the distal migration on cement restrictor using multiple regression analysis. There was no statistical difference between the two types of cement restrictors (P= 0.44). Surgeon, Surgical approach, femoral canal diameter P>
0.2 cementing technique P>
0.1 and Cement viscosity P= 0.082 had no effect on the degree of distal migration of the cement. In conclusion Biostop TM absorbable cement restrictor is as effective as Hardinge TM non-absorbable cement restrictor. We could not show any relationship between femoral canal diameter cementing technique and cement viscosity and distal cement migration which leads us to conclude that in the presence of adequate cement restriction these factors have little effect in distal migration of cement mantle.
The incidence of DVT and need for thrombo-prophylaxis following isolated distal lower extremity fractures is unknown. The purpose of this study was to determine whether or not thrombo-prophylaxis with low molecular weight heparin was needed in this trauma population. A Multicentered Prospective Randomised Double Blind Placebo Controlled Trial was designed to define the incidence of DVT and need for thrombo-prophylaxis in this population. A sample size of two hundred and ninety-nine patients ensured a one tailed type one error of alpha = 0.05 and power of 80% as confirmed from previous studies. Males and female patients between the ages of eighteen and seventy-five years with isolated distal lower extremity fractures (excluding the foot) were eligible. All patients had surgery within forty-eight hours after injury. Patients excluded from the trial were polytrauma patients, those medically unfit for the operating room, patients with foot fractures, those receiving anticoagulation, inability to provide consent, platelets 200 umol /L. Randomization was carried out via computer generation to receive either placebo or Fragmin for fourteen days. At fourteen days, all patients underwent bilateral venograms interpreted by three independent radiologists. Equivocal venograms were interpreted by consensus. Routine follow-up was carried out for all patients at two, six, eight and twelve weeks. A total of two hundred and ninety-nine patients were enrolled in the study. One hundred thirty-six patients in the Fragmin group and one hundred and twentyfive in the placebo group completed the intervention. There were one hundred and twenty-five males and one hundred and thirty-six females in total. There was no statistically significant difference in DVT incidence between those patients treated with Fragmin or Placebo (p = 0.41). Gender, medical issues, pre-operative level of activity and body mass index had no effect on the incidence of DVT. The incidence of DVT in fragmin treated and placebo treated patients is 8.1% and 11.2%, respectively (p = 0.41). This study suggests that DVT thrombo-prophylaxis is not indicated in this patient population. To our knowledge, this is the first Randomised Controlled Trial utilizing venograms (gold standard) for DVT identification.
The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up. We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual.Background
Methods
Controversy exists regarding the optimal technique for arthroscopic rotator cuff repair. The purpose of this multicentre randomized double-blind controlled study was to compare the functional outcomes and healing rates of double-row suture techniques with single row repair. Patients undergoing arthroscopic rotator cuff repair were randomized to receive either a double row (DR) or single row (SR) repair. The primary objective was to compare the WORC score at 24 months. Secondary objectives included anatomical outcomes by MRI or ultrasound, the Constant, and ASES scores. A sample size calculation determined that 84 patients provided 80% power with a 50% effect size to detect a statistical difference between groups.Purpose
Method
We conducted a multicentre two arm double blind randomised controlled trial to assess efficacy of pulsed ultrasound for accelerating the rate of bone healing. Sixty-two skeletally mature adults undergoing limb lengthening, of between 2.5cm to 10cm by distraction osteogenesis, at the proximal tibia using an Ilizarov frame were randomised to either an active or a placebo (control) ultrasound device. Primary outcome measure was time ready for removal of frame after adjusting for distraction length (days/cm) for both intension to treat (ITT) and per protocol (PP) patients. The time at which the frame was removed was determined by the maturation of the regenerate bone. Secondary outcomes were return to weight bearing and covariates affecting time to frame removal. The baseline characteristics of the two groups were well balanced, and 90% of patients were managed and followed up as PP. There was no difference in the time to frame removal between the two groups for the ITT (5.0days/cm, p=0.23) or the PP (10.1days/cm, p=0.054). There was no difference in return to weight bearing between the two groups, after adjusting for distraction length, for the ITT or PP patients (p>0.5). Smoking was the only covariate identified to increase the frame removal time (hazard ratio 0.46, 95% confidence interval 0.22 to 0.96; p=0.04). This trial demonstrated no difference in bone healing between those who underwent pulsed ultrasound and those who did not. Smoking was observed to have a significant inhibitory effect on bone healing.
To assess efficacy of pulsed ultrasound for accelerating regenerate consolidation. A multicentre two arm patient and assessor double blind RCTObjective:
Design:
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.
