Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions.Background
Objectives
Historically the incidence of Achilles re-ruptures has been described as around 5% after surgical repair and up to 21% after conservative management. In 2008 we commenced a dedicated Achilles tendon rupture clinic for both conservative and surgically managed patients using new standardised operating procedures (SOP). We have evaluated the impact of this new service, particularly with regard to re-rupture rate. The SOP was stage dependent and included an initial ultrasound examination, functional orthotics with early weight bearing, accelerated exercise and guidelines for the return to work and sport. Evaluation included re-rupture rate, complication rate, and outcome measured by the Achilles Tendon Total Rupture Score (ATRS) and Achilles Tendon Repair Score (AS). A basic cost evaluation was performed to assess any potential savings.Introduction:
Materials and methods:
Osteotomy through the bare area of olecranon minimises the damage to articular cartilage in the trans-olecranon approach to the distal humerus. In this study we have identified a reliable and easily reproducible anatomical land mark to make sure that the osteotomy passes through the bare area. Two methods were used to determine the line for the osteotomy, in the first a line from the lateral epicondyle perpendicular to the olecranon and in the second an intra-articular marker was used to determine the osteotomy. In 5 cadavers the osteotomy with lateral epicondylar line as a marker went 2 mm proximal to the bare area. Of the 5 cadavers dissected with a marker passed to the angle of olecranon the osteotomy went through the bare area of olecranon in three specimens and just proximal in the other two. In conclusion a cheveron osteotomy with the base of the chevron on the lateral epicondylar line will be the ideal site to make sure that the osteotomy passes through the bare area of the olecranon.
The Bristol Knee Group has prospectively followed the results of over 500 isolated patellofemoral arthroplasties. Initial experience with the Lubinus prosthesis was disappointing. The main causes of failure were mal-tracking and instability leading to excessive polythene button wear and disease progression in the tibio femoral joint. This experience resulted in the design of a new prosthesis to correct the tracking problems and improve the wear. We have now performed over 425 Avon arthroplasties with a maximum follow-up of 9 years. Survivorship at 5 years and the functional outcome have been reported with 95.8% survivorship, and improved function with Oxford score from 18 to 39 points out of 48. There have been 14 cases with mal-tracking (3%). Several of these cases have required proximal or distal realignment with the Elmslie or Insall procedures. Two knees with patella alta required distalisation of the tibial tubercle. Symptomatic progression of the arthritic disease in the medial or lateral tibio-femoral compartments has occurred in 28 cases (7%) causing recurrent joint pain. Radiographic follow-up has shown a higher rate of disease progression emphasising the importance of careful assessment of patients prior to operation. We have investigated 8 cases of persistent unexplained pain. Analysis of these cases suggests 3 possible causes. An extended anterior cut leading to overstuffing, insufficient external rotation and over sizing of the femoral component leading to medial or lateral retinacular impingement. Six of these cases have been successfully treated by revision of the femoral component leading to dramatic resolution of the symptoms.Introduction
Results
The importance of interpreting clinical trial results in terms of the benefits a treatment may offer to individuals with chronic pain is becoming more widely recognized. The clinical meaningfulness of group differences can better be described by looking at the percentages of responders in each treatment group, rather than between group mean differences. We have reassessed the outcomes of a clinical trial for chronic low back pain (LBP) from this new perspective. The randomized clinical trial examined short- (12 weeks) and long-term (52 weeks) efficacy of high-dose, supervised trunk exercise (SET), spinal manipulative therapy (SMT), and a course of home exercise and self-care advice (HEA) for the treatment of LBP ≥ 6 weeks duration. We calculated response to care at 2 levels for 2 variables: numeric back pain scores (NRS) and Roland-Morris Disability (RMD), and at 3 timepoints (Weeks 12, 26 and 52). The 2 levels were calculated as percent improvement from baseline ≥ 30% and ≥75%. Finally, we calculated the relative proportion (± 95% confidence intervals) of the sample (∼100 per treatment group) that achieved each level of improvement.Purpose
Methods
Current orthopedic practice requires consideration of apparently contradictory recommendations regarding VTE prevention among THR/TKR patients. American College of Chest Physicians (ACCP) 8th Clinical Practice Guidelines for the Prevention of Venous Thromboembolism recommend against aspirin for VTE prophylaxis in any patient We conducted a prospective observational study among consecutive patients presenting for total hip or knee arthroplasty. Pre-operative PE risk stratification was performed at the discretion of the surgeon. Patients identified as usual risk for PE received aspirin. Patients considered being at elevated risk for PE received warfarin. This observational study protocol called for one year of data collection. At approximately 8 months 656 patients were enrolled, and the surgeon principally implementing PE risk stratification and administration of aspirin chose to stop enrolling patients due to a high incidence of pulmonary emboli. One hundred fifty five patients received thromboprophylaxis with aspirin 600 mg PR in the PACU, then 325 mg BID for one month (reduced to 81 mg daily if GI symptoms were present). The remaining 501 patients received an ACCP-based warfarin protocol managed by a pharmacist anticoagulation management service. Our hypothesis is the null hypothesis; that an AAOS-based approach to hromboembolism prevention is not inferior to an ACCP-based approach. The a priori primary endpoints of the AVP Study are clinically overt VTE, DVT, PE, major bleeding, and death. All patients will receive a 90 day follow-up questionnaire in person or by telephone. Additionally, the electronic medical record of Intermountain Healthcare will be interrogated for ICD-9 codes germane to the outcomes of interest. Ninety day follow-up has been completed for approximately 140 patients. The dataset will be locked upon completion of the 90 day follow-up among those patients who last received PE risk stratification and aspirin therapy (data lock early June, 2009). We anticipate preliminary data available for report by July, 2009.
Classification of osteoarthritis of the hip is fraught with difficulty Although different patterns of disease are recognised, there is no accepted classification or grading system. We aim to develop a classification system that reflects both the radiological changes, and the local disease process within the joint. After ethical permission and consent tissue was taken from 20 patients undergoing primary hip replacement surgery. Intra-operative tissue samples were taken from each patient and the steady state gene expression of several cytokines (TNF-α, IL1-β, IFN-γ, IL-6, RANKL and OPG) measured quantitatively using Taqman RT-PCR. Relative expression was calculated for each sample using standard curves and normalised to 18S expression. The technique was consistent with high correlations for repeated measures from the same tissue type (κ=0.99) and from different tissue types in the same joint (κ=0.92). Intra-observer (κ=0.93) and inter-observer (κ=0.89) reliability for the technique were also found to be high. Preoperative radiographs were scored by two independent observers and joint space narrowing, cysts, osteophytes and sclerosis noted in each of the DeLee-Charnley zones on the femoral and acetabular side. Based on these scores patients were then classified to either lytic or sclerotic type and subclassified into either hypertrophic or atrophic. Subgroup analysis of cytokine expression by radiographic type was performed. There were statically significant differences in expression of macrophage stimulating cytokines (IL-1γ and OPG) in the lytic group as compared to the sclerotic group (p<
0.05). Conversely, the sclerotic group expressed significantly higher levels of IL-6. Individuals with atrophic subtype demonstrated significantly higher levels of IL-1β and IL-6, but lower levels of IFN-γ Our results demonstrate greatly differing patterns of disease within osteoarthritic hip joints. These changes are reflected in radiographic appearances of osteoarthritis. Our proposed classification system can be used grade and classify osteoarthritis in a manner that reflects the disease process.
We undertook a prospective randomised trial to determine the outcome of locked intramedullary fixation vs. plating of displaced shortened mid-shaft clavicle fractures. The primary outcome measure was the Constant shoulder score, while secondary outcome measures included the Oxford shoulder score, union rate, and complication rates. Thirty-two patients were recruited to the trial; 17 randomised to locked intramedullary fixation and 15 randomised to plating. Mean age was 29.3years (13 to 53 years). Mean follow-up was 12.4 months (5 to 28 months). There was no significant difference in Constant scores (p = 0.365) and no significant difference in Oxford scores (p = 0.686). There was 100% union in both groups. In the intramedullary group, there was one case of soft tissue irritation that settled after the pin was removed, one pin backed out and had to be revised with another pin. There were three superficial wound infections resulting in plate removal and 8 plates (53%) were removed. Locked intramedullary fixation and plating are equally effective in the management of shortened displaced mid-shaft clavicle fractures.
Since 1996 over 400 isolated patellofemoral replacements using the Avon prosthesis have been undertaken in Bristol. As a result of the usually gratifying outcomes seen in patients over 55 years old, the indications for this surgery were soon extended to include the many younger patients who have severely disabling patellofemoral disease. We present results from a prospective cohort study of patients under 55 years of age at the time of surgery. 110 knees in 86 patients (median age 47 years, range 24–54) have been treated with Avon patellofemoral replacement (88 in females and 22 in males). Diagnoses included lateral facet OA (59 knees), patella dislocation (25 knees), trochlear dysplasia (41 knees) and post patellectomy instability (7 knees). 79 knees had undergone previous surgery. 17 knees required additional intra-operative procedures including 11 lateral releases and 2 patella realignments. All patients were assessed pre-operatively and at regular intervals using the Oxford, Bristol and WOMAC scores. All knees were scored preoperative and only one knee has been lost to follow-up due to the patient’s death, which was unrelated to surgery. Post-operative Oxford knee scores have been obtained for 106 knees with follow-up between 8 months and 8 years (mean follow-up 24 months). The mean Oxford score improved from 18 preoperatively to 31 at latest review. Bristol and WOMAC scores showed similar improvements. 16 knees required post-operative additional procedures including 6 lateral releases, 3 patella realignments and 11 revisions. Of the revisions 5 were for progression of tibiofemoral OA but none of these were knees with trochlear dysplasia. Equally good mean scores were seen when comparing patients with the 3 main underlying pathologies (trochlear dysplasia, patellar dislocation and lateral facet OA). At least 37% of the patients studied had pre-existing trochlear dysplasia and the majority of these patients report onset of symptoms, often patellar dislocation, in the first three decades of life. More than 90% of patients were overweight or obese according to their BMI at the time of surgery. Many of this type of patient, with disabling symptoms, wish to “live now”. The short-term improvements are frequently dramatic. As yet there is no suggestion of prosthetic failure. Revision presents little difficulty since minimal bone is resected in the primary proceedure. Radiological deterioration of the tibio femoral joint is seen in some cases of primary OA but not with trochlear dysplasia.
The median pain score rose from 15/40 pre-operatively to 40 points at eight years. The median (MPS) rose from 10/30 points pre-operatively to 25 points at eight years. The median (OKS) rose from 18/48 pre-operatively to 38 at eight years. 87% of knees had mild or no pain at eight years. There were no cases of failure of the prosthesis itself. All 15 revisions resulted from progression of arthrititis in the tibio-femoral joint. The five-year survival rate for all causes with 86 cases at risk was 96%.
99 knees were followed for 15 years and 21 knees for 20 years. The average Bristol knee score of the surviving knees fell from 86 to 79 during the second decade. A previous study showed an 89% 10 year survivor-ship and this is now extended to 82% at 15 years and 76.5% at 20 years.
We report the mid-term results of a new patellofemoral arthroplasty for established isolated patellofemoral arthritis. We have reviewed the experience of 109 consecutive patellofemoral resurfacing arthroplasties in 85 patients who were followed up for at least five years. The five-year survival rate, with revision as the endpoint, was 95.8% (95% confidence interval 91.8% to 99.8%). There were no cases of loosening of the prosthesis. At five years the median Bristol pain score improved from 15 of 40 points (interquartile range 5 to 20) pre-operatively, to 35 (interquartile range 20 to 40), the median Melbourne score from 10 of 30 points (interquartile range 6 to 15) to 25 (interquartile range 20 to 29), and the median Oxford score from 18 of 48 points (interquartile range 13 to 24) to 39 (interquartile range 24 to 45). Successful results, judged on a Bristol pain score of at least 20 at five years, occurred in 80% (66) of knees. The main complication was radiological progression of arthritis, which occurred in 25 patients (28%) and emphasises the importance of the careful selection of patients. These results give increased confidence in the use of patellofemoral arthroplasty.
Degenerative joint disease (DJD) involves the proteolysis of many extracellular matrix molecules (ECM) present in articular cartilage and other joint tissues such as tendon, meniscus and ligaments. Recent research has identified key enzymes involved in the catabolism of ECM. Two classes of enzyme the Matrix Metalloproteinases (MMP’s) MMP-2, MMP-3, MMP-13 and the ADAMTS family (a disintegrin and metalloproteinase with thrombospondin motifs) of proteinases most notably, ADAMTS-1, -4 and −5, have been shown to be involved in the catabolism of ECM (such as type II collagen and cartilage aggrecan). The presence of several MMPs in the synovial fluid has been reported; however, little data has yet been gathered on the presence of ADAMTS-1, -4 or −5 (the aggrecanases) in synovial fluids. In this study we have used a recombinant artificial substrate and specific neoepitope antibodies that recognise either MMP- generated or aggrecanase -generated degradation products to measure the relative activity of these two enzyme families in the synovial fluid from human patients.
Between 1989 and 1992 a randomised prospective study was undertaken in which 102 cases adjudged suitable for UKR were allocated to receive either a St Georg Sled UKR or a Kinematic Modular TKR. Both cohorts had a median age of 68 and a similar sex distribution and preoperative knee score. Regular follow up has been maintained. As reported the early results favoured UKR. All cases have now been assessed after a minimum of 10 years using modified WOMAC, Oxford and Bristol Knee Scores (BKS) as well as radiographs.
At 10 years the UKR group had better Oxford and WOMAC scores as well as significantly more excellent results (19:14) and fewer fair and poor results on the BKS. Both groups averaged over 105′ of flexion but 61% of the UKR and only 15% of the TKR group had 120′ or more of flexion.
We propose a grading system for contrast free MRI images of tennis elbow and evaluate the inter and intra observer variability of their interpretation.
Our proposed grading system of 1 to 5 based on the pattern around the common extensor tendon was used. Images of the symptomatic and contralateral non symptomatic elbows were graded blindly twice with an interval of 1 month by each surgeon. Each surgeon graded 176 MRI images twice. The grades were subsequently grouped into (I) grades 1 to 2 and (II) grades 3 to 5
The inter observer agreement between consultant A and B was 82.46%, between A and C 67.1% and between B and C 80.1%. It was also noted that there were systematic differences to the inter observer variability. Consultant A graded the images 3 to 5 on both occasions 52.9% of the time, consultant B graded 3 to 5 on both occasions 37.8% of the time and consultant C graded 3 to 5 on both occasions 23.3% of the time.
The UKR group had better scores with Oxford: 38 v 34 /48 and WOMAC: 17 v 21 /60 and more excellent results (19 v 14) and fewer fair and poor results on the BKS (4 v 6). The range of movement improved in UKA`s from 107 degrees to 117 degrees, whereas the range decreased in TRK`s from 107 degrees to 104 degrees. Sixty-one percent of the UKR and only 16% of the TKR group had more than 120 degrees of flexion.
Traditionally midshaft clavicle fractures have been treated conservatively. It is recognized that displaced and shortened fractures may be better treated operatively. In particular, patients with greater than 20 mm of shortening and 100 percent displacement have a symptomatic non union rate of 30 percent. The standard technique used previously has been via plate fixation with LC-DCP or DCP. However in the last 5 years intramedullary fixation has been popularized. “Rockwood intramedulary clavicular pin” remedies the past treatment issues including poor blood supply, painful prominent hardware and stress raiser related to removal of metal work.
The aim of the study was to determine the effects of 0 Ticron suture soaked in polyhydroxybutyrate (PHB) on the histological and mechanical properties of healing meniscal tears in the red-white zone in an established animal model.
To determine whether the Dynamic Condylar Screw, DCS, is suitable in treating pathological subtrochanteric fractures of the femur and the incidence of failure with this device. Nineteen sequential and unselected patients with twenty femurs with pathological subtrochanteric fractures, or impending fractures, were identified, which had been treated with DCS. Mean age was seventy. Follow up was until functional union (minimum follow up 18 months) or until death. Primary tumour was identified in seventeen of the nineteen cases. Grade of surgeon was recorded as was the use of adjunctive measures at the time of surgery (PMMA). Subsequent failure, cause and need for revision was noted. Operative morbidity was low and initial pain relief good in all cases. Two fractures went on to unite. Eight original implants survived until the patient died (mean survival time 24 days). Ten implants failed (50%). Failure resulted from fracture through the DCS plate in eight cases and cut out of the screw in the other two. Of these, five patients (6 femurs) went on to further operative procedures. The others were either deemed unfit (3 cases) or refused further surgery (1 case). In the light of newer intramedullary techniques we feel the DCS should be used with caution in this type of fracture. DCS in this fracture is associated with a high degree of failure.
Surgeons often protect Tendon-bone reconstructions such as rotator cuff repairs by off loading them. We investigated the effect of limb position and boundary conditions in an in-vitro rabbit patella tendon-bone repair model. Patella tendons were repaired back to the tibia in eight hindlimb cadavers with 2 mitek anchors(Mitek, Westwood, MA) and 3-0 Ethibond (Ethicon, Sommerville, NJ) using two techniques, one involving simple sutures and the other involving crossing over between the sutures. A loading mechanism through the patella tendon was constructed using static weights over a pulley mechanism. The contact area and force at the PT-bone interface were measured using a TekScan pressure sensor (6911, TekScan, South Boston, MA). The contact footprint (area and normal force) was acquired under four configurations: (1) knee full extension with interface unloaded, (2) knee 45° flexion with interface unloaded, (3) knee full flexion with interface loaded by limb weight alone, (4) tendon loaded with limb weight and 20N force applied through tendon loading mechanism. The contact area force footprint changed substantially between the different suture techniques and loading configurations. Crossing over of sutures appears to provide an increased and more evenly distributed force across the tendon-bone interface. Repair off-loading was accompanied by a decrease in the contact footprint force and pressure. The force in both suture techniques increased with increasing flexion angle and was substantially increased by both bearing the weight of the dependent limb and by an axial load in the patellar tendon. Off loading a repair may not provide optimal environment for healing.
In Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) the total blood loss is composed of ‘visible’ blood loss from the surgical field and wound drainage, and blood loss into the tissues which is ‘hidden’. Blood management should be aimed at addressing the total blood loss. 56 TKAs and 46 THAs were prospectively studied. TKAs were performed with tourniquet. After tourniquet release, all drained blood was salvaged and significant volumes reinfused. No reinfusion was used for THAs. The true total blood loss was calculated in the following way: Patient Blood Volume (PBV) is: [1] PBV = k1 x height3 + k2 x weight + k3 Therefore patient total Red Blood Cell volume (RBCv) is: RBCv = PBV x Hct. (where Hct is Haematocrit) Total RBCv loss = PBV x (Hct preop – Hct postop) + ml RBC transfused The result is reconverted to Whole Blood volume. Hidden Loss = Total Loss – Visible Loss. In TKA, the mean total true blood loss was 1474ml. The mean hidden loss was 735ml. Therefore hidden loss is 50% of the total loss and the total true loss following TKA is twice the visible volume. In THA, the mean total true blood loss was 1629ml. The mean hidden loss was 343ml. Thus hidden loss in THA is much smaller. (21%) Total loss is 1.3 times the visible loss. In the TKA group, comparing patients with large losses receiving reinfusion and those with small losses not receiving reinfusion, the proportion of total true loss which was hidden was the same, at 50%. Patients with Body Mass Index (BMI) >
30 were compared with those with a BMI <
30 and no correlation was found between BMI and Hidden Loss. Joint Replacement Surgery involves a ‘hidden’ blood loss which is not revealed and cannot be measured or reinfused in practice, but which should be taken into account when planning blood loss management. In TKA it is substantial. In THA it is much smaller and probably not of as much clinical concern. Hidden loss is no greater in the Obese patient.
At 10 years the cumulative survival rate was 83% and at 15 years 78% (10 knees at risk). The “worst case scenario” where knees with pain or lost to follow up are added to revisions shows a 10 year survivorship of 74%.
Horse riding is a common pursuit and is more dangerous than believed. Most injuries of the hand and wrist are caused by falls, as in other sports. However, exclusive to riding are injuries sustained whilst leading a horse. Avulsion injuries are well recognised but little has been reported on phalangeal fractures in this situation. We report on seven cases that required hospitalisation in our hand unit, for injuries from horses over a two year period. Six of these patients sustained multi-fragmented spiral periarticular fractures involving the middle and proximal phalanx and one a horse bit. We will discuss in detail the mechanism of their injuries, the surgery undertaken, their post-operative rehabilitation and overall outcome. Furthermore we review the recommended horse handling technique and contrast it with the mechanism of injury in our cases. In our experience the fractures seen were unstable, comminuted and needed internal fixation. One patient developed a delayed union and three post-operative stiffness. Our results suggest that fractures whilst leading horses are more complex than recognised, usually need surgery and often have a relatively poor outcome. All of these cases were largely preventable and could be attributed to incorrect horse leading technique.
Previous clinical studies have studied tibiofibular torsion by measuring the angular difference between a proximal (often bicondylar) plane and a distal bimalleolar plane. We measured the angular difference between the proximal and distal posterior tibial planes as defined by ultrasound scans. We found no significant torsional difference between the right and left tibiae of 87 normal children, nor between their different age groups. The mean external torsion of 58 legs with congenital talipes equinovarus was 18 degrees; significantly less than the mean 40 degrees in the normal children and 27 degrees in the clinically normal legs of the 22 patients with unilateral congenital talipes equinovarus. We did not confirm the previously reported increase in external torsion with increasing age. The relative internal tibial torsion we have demonstrated in patients with congenital talipes equinovarus must be differentiated from the posterior displacement of the distal fibula observed by others and which may result from manipulative treatment. The relative internal tibial torsion we found in the clinically normal legs of children with congenital talipes equinovarus is further evidence that in this condition the pathology is not confined to the clinically affected foot.
The parameters of cellular proliferation and growth in the growth plates of immature rats were measured after unilateral tibial osteotomy and used to calculate growth rates. Distal osteotomy of one tibia was followed by a bilateral increase in the calculated growth rate of the distal growth plates. However, the ipsilateral distal growth plate grew faster than the contralateral between 12 and 18 days after operation, which appeared to be related to increased cell proliferation and height. Proximal osteotomy led to an increase in growth rates proximally which was more marked on the contralateral side. The lesser response of the ipsilateral growth plate may have been due to local impairment of blood supply, or to greater local release of metabolites after bony damage. Distal tibial osteotomy gave similar results to circumferential release of the distal tibial periosteum. Proximal osteotomy, however, produced a relative impairment of growth on the operated side. This may be of importance in the correction of childhood deformities associated with inequality of leg length.