Early active training after lumbar discectomy. A prospective, randomized, and controlled study

STUDY DESIGN: A prospective, randomized, and controlled study was conducted. OBJECTIVES: To evaluate two training programs, both of which started immediately after lumbar discectomy. SUMMARY OF BACKGROUND DATA: In previous studies, patients began physiotherapy between 4 weeks and 60 months after surgery. No studies have been conducted to evaluate a physiotherapy program that begins immediately after surgery. METHOD: Twenty-six patients were treated according to an early active training program. Twenty-six patients were treated with a traditional, less active training program (control group). All patients were examined immediately before and after surgery and 3, 6, 12, and 52 weeks after surgery by an unbiased observer. Two years after surgery, patients completed a questionnaire. Range of motion of the lumbar spine and straight leg raising were measured. pain intensity and location was measured by a visual analog scale. The duration of sick leave was documented. RESULTS: Six and 12 weeks after surgery, patients with dominating residual leg pain had significantly less intense pain in the early active training group than those in the control group (P < 0.05). Twelve weeks after surgery, range of motion of the lumbar spine was significantly more increased in the early active training group (P < 0.01). One year after surgery, there was no significant difference between the groups regarding the duration of sick leave, results in a positive straight leg raising, or pain intensity. Twenty-two (88%) patients in the early active training group and 16 (67%) in the control group were satisfied with the treatment outcome 2 years after surgery (P < 0.10). CONCLUSIONS: Patients rehabilitated according to the early active training program had a better short-term outcome of objective values. At 2 years' follow-up, more patients were satisfied with the result of the operation. The early active treatment program is recommended.     

A randomized, controlled, clinical study of laparoscopic vs open tension-free inguinal hernia repair

BACKGROUND: The aim of this prospective, randomized, controlled clinical study was to compare laparoscopic transabdominal preperitoneal (TAPP) hernia repair with a standard tension-free open mesh repair (open). METHODS: A total of 108 low-risk patients with unilateral (primary or recurrent) or bilateral hernias were randomized to TAPP (group 1 = 52 cases) or open (group 2 = 56 cases). The outcome measures included operating time, complications, postoperative pain, return to normal activity, operating theater costs, and recurrences. RESULTS: The mean operative time was longer for the TAPP than for the open group only in unilateral primary hernias. At rest, the median Visual Analog Scale (VAS) score was higher for group 1 than group 2 at 48 h postoperatively. Mild to discomforting pain in the inguinal region after 7 days, night pain after 30 days, and inguinal hardening after 3 months were more frequent in group 2 than group 1. No significant differences were observed in return to normal activities between the groups. One hernia recurrence was observed after 1 month in group 1. TAPP was significantly more expensive than open. CONCLUSIONS: TAPP was associated with less postoperative pain than open. The increase in operating theater costs, however, was dramatic and was not compensated by shorter time away from work. TAPP should not be adopted routinely unless its costs can be drastically reduced.     

Quality of life after knee arthroplasty. A randomized study of 3 designs in 42 patients, compared after 4 years

BACKGROUND: An initial multicenter study using a 21 mm flanged esophageal Z stent demonstrated excellent palliation but an 11% immediate complication rate at placement and a 27% migration rate at 1 month. This North American multicenter trial prospectively studied a 25 mm flanged Z stent to define its palliative ability and whether the increased diameter affected placement or migration problems. METHODS: Fifty patients who had esophageal Z stents at seven university or regional referral hospitals were prospectively studied. Indications for prosthesis placement, previous therapy, patient demographics, incidence of concomitant tracheoesophageal fistula, and degree of dysphagia were defined, as were procedural and subsequent stent-related problems, survival times, the ability to occlude a tracheoesophageal fistula, and subsequent degree of dysphagia. RESULTS: Twenty-four patients had infiltrating malignancy (16 exophytic and 10 extrinsic), 9 of whom had concomitant tracheoesophageal fistulas. Ten patients (20%) had misplaced stents requiring retrieval and replacement, 12 patients (24%) had subsequent stent-related problems including exsanguination (2), aspiration (3), tumor overgrowth (3), and postplacement migration (4) (8%). There was statistically significant improvement in prestent versus poststent dysphagia and two thirds of patients had complete occlusion of their tracheoesophageal fistula. CONCLUSIONS: Redesign of the esophageal Z stent has decreased the migration rate without increasing placement or subsequent erosion problems. Its efficacy appears comparable to the currently marketed Z stent for the palliation of malignant dysphagia and occlusion of tracheoesophageal fistula.     

The effect of hydroxyapatite on the micromotion of total knee prostheses. A prospective, randomized, double-blind study

A prospective, randomized, double-blind study was performed to evaluate three different means of fixing tibial components during total knee arthroplasty. Eleven components fixed with cement, ten hydroxyapatite-coated components fixed without cement, and ten noncoated components fixed without cement were studied. A posterior cruciate ligament-retaining total condylar implant was used. Micromotion of the components was assessed with roentgen stereophotogrammetric analysis during the two-year follow-up period. There were no significant differences among the patients with regard to age (mean [and standard deviation], 68 +/- 11.6 years), body-mass index (mean, 23 +/- 2.8 kilograms per square meter), or stage of osteoarthrosis (mean, 4 +/- 2.4 according to the classification system of Ahlback and 5 +/- 0.6 according to that of Larsen et al.). The diagnosis was osteoarthrosis in five knees, and it was rheumatoid arthritis in twenty-six. The clinical scores were similar among the study groups. According to the system of the Knee Society, the mean preoperative functional score was 10 +/- 2.9 points and the mean preoperative knee score was 24 +/- 3.2 points. At the two-year follow-up evaluation, these scores were 41 +/- 8.3 and 79 +/- 3.2 points, respectively. A significant difference with regard to micromotion was found between the noncoated components fixed without cement and the hydroxyapatite-coated components fixed without cement as well as between the noncoated components fixed without cement and the components fixed with cement (p < 0.001, analysis of variance). The hydroxyapatite-coated components fixed without cement and the components fixed with cement both had far less micromotion along the longitudinal axis (subsidence) throughout the follow-up period than did the noncoated components fixed without cement. At the two-year follow-up evaluation, the subsidence of the noncoated components was -0.73 +/- 0.924 millimeter, the subsidence of the cemented components was -0.05 +/- 0.109 millimeter, and the subsidence of the hydroxyapatite-coated components was -0.06 +/- 0.169 millimeter. The cemented components as well as the hydroxyapatite-coated components also had less translation along the transverse axis (p < 0.001, analysis of variance) and the sagittal axis (p < 0.001, analysis of variance) compared with the noncoated components. In conclusion, micromotion of hydroxyapatite-coated tibial components fixed without cement was similar to that of tibial components fixed with cement. Therefore, hydroxyapatite, a biological mediator, may be necessary for the adequate fixation of tibial components when cement is not used.     

The use of isoxsuprine in essential dysmenorrhea. A controlled clinical study

The "uterus-specific" beta-adrenoceptor stimulator isoxsuprine was used for the treatment of primary dysmenorrhea in a double-blind controlled clinical study. No significant beneficial effect of the drug was evident.     

Hope, self-efficacy, and functional recovery after knee and hip replacement surgery.

Objective: To test hypothesized relations between hope and self-efficacy for rehabilitation to depression and functional ability reported by individuals receiving joint replacement surgery. Study Design: Community-dwelling older adults (N = 100) from an orthopaedic clinic were administered measures of hope, self-efficacy for rehabilitation, pain, depression, body mass index (BDI), and mental status 1 month prior to their joint replacement surgery. These measures were completed by 62 participants 6 weeks after surgery. Demographic, health information, and functional outcome measures were obtained by medical personnel pre- and postsurgery. Main Outcome Measures: Functional outcome measures (Harris Hip and Knee Society Scores) and depressive symptomatology. Results: Hope was significantly predictive of presurgery depression, but it was not predictive of depression or functional ability after surgery. Higher levels of self-efficacy were predictive of lower postsurgery depression scores. Conclusions: Results imply that social-cognitive constructs may have utility in the prediction of emotional adjustment before and after joint surgery, but they may have limited value in anticipating functional abilities following these surgeries. Theoretical and clinical implications are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Oral delivery of anticoagulant doses of heparin. A randomized, double-blind, controlled study in humans

BACKGROUND: Parenteral heparin is the anticoagulant of choice in hospitalized patients. Continued anticoagulation is achieved by subcutaneous administration of low-molecular-weight heparin or with an orally active anticoagulant such as warfarin. An oral heparin formulation would avoid the inconvenience of subcutaneous injection and the unfavorable drug interactions and adverse events associated with warfarin. A candidate delivery agent, sodium N-[8(-2-hydroxybenzoyl)amino]caprylate (SNAC), was evaluated with escalating oral heparin doses in a randomized, double-blind, controlled clinical study for safety, tolerability, and effects on indexes of anticoagulation. METHODS AND RESULTS: Increases in activated partial thromboplastin time (aPTT), anti-factors IIa and Xa, and tissue factor pathway inhibitor (TFPI) concentrations were detected when normal volunteers were dosed with 10.5 g SNAC/20000 IU heparin by gavage in some subjects. For the entire group, 30000 IU SNAC and heparin elevated TFPI from 74.9+/-7.6 to 254.2+/-12.3 mg/mL (P<0.001) 1 hour after dosing (P<0.001). Similar changes occurred in anti-factor IIa and anti-factor Xa. aPTT rose from 28+/-0.5 to 42.2+/-6.3 seconds 2 hours after dosing (P<0.01). No significant changes in vital signs, physical examination, ECGs, or clinical laboratory values were observed. Neither 30000 IU heparin alone nor 10.5 g SNAC alone altered the hemostatic parameters. Emesis was associated with 10.5 g SNAC. A taste-masked preparation of SNAC 2.25 g was administered orally with heparin 30000 to 150000 IU. Both aPTT and anti-factor Xa increased with escalating doses of heparin. This preparation was well tolerated. Conclusions-Heparin, administered orally in combination with the delivery agent SNAC, produces significant elevations in 4 indexes of anticoagulant effect in healthy human volunteers. These results establish the feasibility of oral delivery of anticoagulant doses of heparin in humans and may have broader implications for the absorption of macromolecules.     

Rehabilitation after aortic valve replacement with autologous fascia lata: a sociomedical study

In a series of 50 patients who underwent aortic valve replacement with frame-supported fascia lata, 32 were seen for a combined medical and psychosocial examination 10 to 33 months postoperatively. The investigation included a psychometric test battery and an interview concerning the patient's social and psychological situation at the time of the operation and at follow-up. Twenty-seven patients had improved in their New York Heart Association Functional Classification at the time of follow-up. In most instances NYHA classification correlated well with the patients' subjective opinion on their recovery. Those who for various reasons were not able to return to work did not consider themselves recovered. The employment rate after operation was 66%. There is a great need for more information and support to families as well as for more intensive rehabilitation efforts, especially vocational, for the postoperative patient.     

A randomized controlled outcome and follow-up study of Mann's time-limited psychotherapy.

Thirty-three patients were assessed for suitability for time-limited psychotherapy (TLP). A battery of outcome measures was composed of Ss self-report measurements and objective judgments by external ("masked") raters. Ss were randomly assigned to either the experimental group, which received TLP immediately, or the control group, whose TLP was delayed for 3 months. Ss were evaluated on outcome measures at TLP termination and again at 6 and 12 months after termination. Significant improvement was observed in the experimental group after TLP, but the control Ss did not show any systematic changes after waiting. However, after TLP, the control Ss improved significantly. The gains achieved after therapy were stable in both groups after 6- and 12-month follow-ups. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A strategy to use soft data effectively in randomized controlled clinical trials.

Soft data are defined as measures having substantial intrasubject variability due to errors of measurement or to the inconsistency of subjects' responses. Such data are often important measures of response in randomized clinical trials. In this context, we show that using an intensive design and the slope of response on time as the outcome measure (a) maximizes sample retention and (b) decreases within-group variability, thus (c) maximizing the power of test procedures without requiring increased sample sizes. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Results of knee replacement with the Walldius and geometric prostheses. A comparative study

Sixty-two knees that were replaced with Walldius prostheses and twenty-five knees with geometric replacements were studied prospectively. The follow-up ranged from twenty-four to 162 months (average, seventy-four months) for the knees with the Walldius prostheses and from twenty-four to seventy-five months (average, forty-seven months) for those with the geometric prostheses. Using a 100-point clinical rating scale, the knees of patients who underwent Walldius replacement improved from their preoperative status by an average of 33 points (from 44 to 77 points) and those with geometric prostheses, an average of 24 points (from 54 to 78 points). Twelve patients with twenty Walldius prostheses were followed for more than 100 months (average, 127 months). The greater average improvement (36 points) in this group was due primarily to the absence of any major complications. Six patients underwent replacement of one knee with a Walldius prosthesis and one knee with a geometric implant. Although the ratings for the two knees were similar in each patient, four patients preferred the Walldius implant; one, the geometric replacement; and one had no preference. Significant technical errors or complications (defined as those affecting the end result) occurred in 8 per cent of the knees with Walldius implants and in 12 per cent of the knees in the geometric group. There were two late infections in each group. One Walldius prosthesis was removed and the knee was fused. The other three prostheses (one Walldius and two geometric) associated with infection were salvaged.     

Treatment of deep and shallow intrabony defects. A multicenter randomized controlled clinical trial

This prospective multicenter intra-individual randomized controlled clinical trial was designed to compare the efficacy of guided tissue regeneration (GTR) with bioresorbable barrier membranes versus access flap surgery, in intrabony defects. 2 similar defects were selected in each of 23 patients and randomly assigned to 1 of the 2 treatments. Surgery consisted of an identical procedure except for the omission of the barrier membrane in the flap control sites. At 1-year, probing pocket depth reductions were 4.3+/-2.3 mm in GTR treated sites and 3.0+/-1.5 mm in the flap control sites (p=0.02, paired t-test). Clinical attachment level (CAL) gains were 3.0+/-1.7 mm in the GTR sites and 1.6+/-1.8 mm in the control sites (p=0.009, paired t-test). A subset analysis, performed according to the initial depth of the intrabony component of the defects (INFRA), indicated that in shallow defects (INFRA < or =3 mm) treated with the access flap alone, CAL gains were 1+/-1.5 mm, while in deep ones (INFRA > or =4 mm) they were consistently greater (1.9+/-1.9 mm). The % CAL gains, calculated as the % of the baseline intrabony component depth, however, were almost identical in the 2 subpopulations (45.8+/-64.7% in shallow and 43.8+/-37.6% in deep defects). Similarly, in the GTR sites, linear CAL gains were greater in deep (3.7+/-1.7 mm) than in shallow defects (2.2+/-1.3 mm), but no differences were observed in terms of % CAL gains (76.7+/-27.7% and 75.8+/-45%, respectively). The frequency distribution of CAL changes expressed as %s of the baseline INFRA indicates that most of the sites treated with GTR (73% in shallow and 92% in deep defects) gained 50% or more CAL. Furthermore, many defects (64% of shallow and 33% of deep defects) reached 100% of CAL gain. The present study demonstrated that: (i) GTR with bioresorbable barrier membranes resulted in a significant added benefit in comparison with access flap alone; (ii) the linear amounts of CAL gains were greater in deep than in shallow defects; (iii) CAL gains expressed as %s of the baseline depths of the intrabony component, were similar in shallow and deep defects; (iii) the regenerative procedure tested in the present study resulted in CAL gains equal to the depth of the intrabony component of the defect in some, but not in most of the instances.     

Total knee replacement after failed tibial osteotomy: results of a matched-pair study

Sixty-three total knee replacements were performed after a failed tibial osteotomy. The goal of this study was to compare the perioperative problems and the outcome of this group of patients (study group) to a group of patients with primary arthroplasties matched for age, gender, length of follow-up, weight, and preoperative Charnley class. Operative problems were more frequently encountered in the study group, with 7 tibial tubercle elevations and 15 lateral retinaculum releases needed, whereas lateral retinaculum release was necessary for only 1 knee in the control group. Outcome was assessed using both the International Knee Society (IKS) scoring system and Hospital for Special Surgery (HSS) knee score. The follow-up period averaged 4.6 years. The IKS score of the control group was significantly higher, averaging 80.9 +/- 13.8, whereas it was 74.4 +/- 14.8 for the study group (P = .0001). Among the parameters included in the knee score, only pain was significantly different with the control group (P = .03). The IKS function score and the HSS score were not statistically different. Conversion of a failed tibial osteotomy is a technically demanding procedure. Careful preoperative planning is needed. Results, especially on pain, appeared to be inferior to those for primary arthroplasties.     

Octreotide: effective treatment for hyperparathyroidism? A prospective, randomized, controlled clinical trial

Although clinical and electrophysiological evidence indicates that the amygdaloid body plays an important role in the pathogenesis of temporal lobe epilepsy, there are very few detailed data on histopathological changes in this nucleus in epilepsy patients. In the present study we have examined the lateral nucleus of the amygdaloid body in 70 surgical specimens from patients with temporal lobe epilepsy and in 10 control specimens with respect to neuronal density and gliosis. The results were compared to the neuronal loss in the hippocampal formation. Our goal was to examine the pathological alterations of the amygdaloid body and their correlation with other morphological changes in temporal lobe epilepsy. In epilepsy patients with Ammon's horn sclerosis or focal lesions of the temporal lobe, the neuronal density of the lateral amygdaloid nucleus was significantly decreased as compared to normal controls (P < 0.001). Overall, the mean volumetric density in epilepsy patients was reduced to 59% of that in normal individuals. There was no correlation between the neuronal density in the lateral amygdaloid nucleus and that in the different segments of the hippocampal formation or to the age at onset or the duration of epilepsy. The neuronal loss of the amygdaloid nucleus correlated well with the presence of fibrillary gliosis. Our findings demonstrate that the amygdaloid body is severely altered in most patients with temporal lobe epilepsy and that these changes are independent of those in the hippocampus. The presence of neuronal loss and gliosis in the amygdaloid nucleus of patients with focal lesions but no Ammon's horn sclerosis is compatible with an involvement of the amygdala in secondary epileptogenesis.     

Ultrasonographic screening before hospital discharge for deep venous thrombosis after arthroplasty: the post-arthroplasty screening study. A randomized, controlled trial

OBJECTIVE: To relate the histological composition of carotid artery plaques with morphology as evaluated by B-mode ultrasound. DESIGN: Prospective study. MATERIAL AND METHODS: Seventy-eight symptomatic patients underwent carotid endarterectomy after preoperative ultrasound Duplex scanning evaluating plaque morphology. Morphometric analysis of the removed specimen was performed in order to quantify content of lipid, haemorrhage, calcification and fibrous tissue. RESULTS: Echolucent plaques contained more lipid (p = 0.01) and less calcification (p = 0.01) and fibrous tissue (p = 0.03) than echo-rich plaques. Intraplaque haemorrhage was directly related to lipid content (p = 0.004) and inversely related to amount of fibrous tissue in the plaque (p = 0.02). CONCLUSION: The intensity of the reflected B-mode ultrasound signal appears related to the histological composition of the plaque. The association between intraplaque haemorrhage and a high lipid content may support the theory of the lipid-rich plaque being more prone to rupture.     

Abstinence or controlled drinking goals for problem drinkers: A randomized clinical trial.

24 adult problem drinkers were assigned to brief behavioral treatment with either an abstinence (AB) or a controlled drinking (CD) goal. Self-report and collateral report data reflect significant overall reduction in alcohol consumption and projected blood alcohol peaks at 3-mo and at 3.5-yr follow-up intervals. AB and CD Ss did not differ significantly from each other on outcome variables at any point before or after treatment. At 3.5 yrs, 4 Ss had been abstinent for at least 12 mo, 3 had been moderate and asymptomatic drinkers for at least 12 mo, 5 were improved but still somewhat impaired, 8 were unimproved, 3 refused to be interviewed, and 1 could not be located. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Immune reconstitution after autologous progenitor hemopoietic cell transplantation. A study comparing autologous bone marrow and autologous peripheral blood transplantation

BACKGROUND: In order to find out the effect of peripheral blood (PB) hematopoietic progenitor cells on immune reconstitution the present study compares, through a randomized trial, some lymphoid subsets after peripheral blood (PBT) or bone marrow (BMT) autologous transplantation. MATERIAL AND METHODS: Twelve patients suffering from malignant hematological disorders were included (6 BMT and 6 PBT). From these patients 14 lymphoid and natural killer (NK) subsets were sequentially analyzed using appropriate dual staining. NK activity was analyzed by measuring Cr51 release from the K562 cell line. Studies were done in days and -6, +10, +17, +24, +31, +38, +52, +66, +90, +120, +180 and +360 after transplantation. RESULTS: The CD8+ cell regeneration was produced mainly by activated cells (CD38+), and no differences were observed between BMT and PBT, but CD8+ HLADR+ cells were higher in the PBT group. During the first year after transplantation CD4+ lymphoid cells were never within normal range, and its recovery was due to the memory subset (CD4+/CD45RO+). The CD19+ lymphocytes began their regeneration after the first month and it was produced mainly by by the CD19+/CD5+ subset. NK cells recovered faster in patients who underwent PBT, but NK activity was similar in both subgroups of patients and it was within normal range from day +17 until the end of the study. CONCLUSION: T, B and NK lymphoid reconstitution do not differ significantly between patients that receive BM or PB as hemathopoietic rescue, but PB seems influence a faster reconstitution of cytotoxic subsets (CD8+/HLADR+ and NK lymphoid cells).     

Intraoperative cholangiography as a routine method? A prospective, controlled, randomized study

A prospective, controlled, randomized trial was conducted in 275 patients with symptomatic gall stone disease, whose history, laboratory data or sonographical findings did not suggest common bile duct stones. Of these patients, 137 did not undergo intraoperative fluoroscopic cholangiography (IOC), but in the remaining 138 patients IOC was attempted. In 111 cases (80.4%) the biliary system was sufficiently visualized. In 3 patients (2.7%) calculi in the cystic or common bile duct were diagnosed, which would have been overlooked without IOC. IOC was false-positive in one case. One year after the operation the patients were asked to return for a follow-up examination. Three patients in the group without IOC had had symptomatic passage of a stone, and one had a common bile duct stone removed by endoscopic papillotomy. A retained stone was discussed as etiology for a pancreatitis in a fifth patient in this group. No patient sustained long-term sequelae from the retained common bile duct stones. None of the patients in the IOC group had evidence of cholangiolithiasis at follow-up. There was no difference between the study groups concerning the incidence of post-operative complications. The operations with IOC lasted significantly longer (92 +/- 31 min vs 77 +/- 28 min). According to our data and those published earlier, the additional financial and logistic expenditure associated with routine IOC is not justified. Patients with the preoperative suspicion of a common bile duct stone should have endoscopic bile duct clearance (ERCP and EPT) prior to cholecystectomy.