Effect of bioactive coating of the tibial component on migration pattern in uncemented total knee arthroplasty: a randomized RSA study of 14 knees presented according to new RSA-guidelines

Background  Bioactive coating of uncemented total knee arthroplasty (TKA) is believed to increase bone ingrowth and enhance early fixation of the TKA. In a prospective randomized study using radiostereometric analysis (RSA) we examined migrations of the tibial implant, in an uncemented TKA with and without bioactive coating. The study was performed according to new RSA guidelines, and focus was put on some important methodological issues. Materials and methods  Twenty-three patients with osteoarthrosis of the knee received an uncemented Duracon TKA either with bioactive (hydroxyapatite or periapatite) coating (+HA) or without bioactive coating (−HA). Patients had RSA examinations postoperatively and at 3, 6 and 12 months. Nine patients were excluded during the study resulting in 14 knees for final analysis. Results  At 12 months follow-up we found no significant differences in migrations between the two groups. However, in general the −HA group migrated more than the +HA group, and we found a significant larger variation in migration pattern in the −HA group. In the +HA group the tibia component stabilized after 6 months, whereas the −HA group showed continuous migration. Subsidence and posterior tilt were the main migration patterns in both groups. Conclusions  Bioactive coating of TKA seems to enhance early stabilization of the tibia component. Similar results are found in previous studies.     

Corticosteroid effectiveness in IgA nephropathy: long-term results of a randomized, controlled trial

Proteinuria plays a causal role in the progression of IgA nephropathy (IgAN). A previous controlled trial showed that steroids are effective in reducing proteinuria and preserving renal function in patients with IgAN. The objective of this study was to evaluate the long-term effectiveness of steroids in IgAN, examine the trend of proteinuria during follow-up (starting from the hypothesis that the degree of reduction in proteinuria may influence IgAN outcome), and evaluate how histologic scores can influence steroid response. A secondary analysis of a multicenter, randomized, controlled trial of 86 adult IgAN patients who were receiving supportive therapy or intravenous methylprednisolone plus oral prednisone for 6 mo was conducted. Ten-year renal survival was significantly better in the steroid than in the control group (97% versus 53%; log rank test P = 0.0003). In the 72 patients who did not reach the end point (doubling in baseline serum creatinine), median proteinuria significantly decreased (1.9 g/24 h at baseline, 1.1 g/24 h after 6 mo, and 0.6 g/24 h after a median of 7 yr). In the 14 progressive patients, proteinuria increased from a median of 1.7 g/24 h at baseline to 2.0 g/24 h after 6 mo and 3.3 g/24 h after a median of 5 yr. Steroids were effective in every histologic class. Cox multivariate regression analyses showed that, in addition to steroids, a low baseline histologic score, a reduction in proteinuria after 6 mo, and no increase in proteinuria during follow-up all were independent predictors of a beneficial outcome. Steroids significantly reduce proteinuria and protect against renal function deterioration in IgAN. The histologic picture and proteinuria during early and late follow-up improve the prediction of outcome, but considerable variability remains outside the model.     

Equivalent 2-year stabilization of uncemented tibial component migration despite higher early migration compared with cemented fixation: an RSA study on 360 total knee arthroplasties

Background and purpose — Thresholds of implant migration for predicting long-term successful fixation of tibial components in total knee arthroplasty have not separated cemented and uncemented fixation. We compared implant migration of cemented and uncemented components at 1 year and as the change in migration from 1 to 2 years.

Patients and methods — Implant migration of 360 tibial components measured using radiostereometric analysis was compared at 1 year and as the change in migration from 1 to 2 years in 222 cemented components (3 implant designs) and 138 uncemented components (5 implant designs).

Results — 1-year maximum total point motion was lower for the cemented tibial components compared with the uncemented components (median = 0.31?mm [0.03–2.98] versus 0.63?mm [0.11–5.19] respectively, p < 0.001, mixed model). The change in migration from 1 to 2 years, however, was equivalent for cemented and uncemented components (mean [SD] 0.06?mm [0.19] and 0.07?mm [0.27] mm respectively, p = 0.6, mixed model).

Interpretation — These findings suggest that current thresholds of acceptable migration at 1 year may be better optimized by considering cemented and uncemented tibial components separately as higher early migration of uncemented components was not associated with decreased stability from 1 to 2 years.     

Prophylactic sclerotherapy in children with esophageal varices: long-term results of a controlled prospective randomized trial

BACKGROUND/PURPOSE: Experience using endoscopic prophylactic sclerotherapy (PS) is restricted to adult patients and has led to conflicting results. There has not been a randomized, controlled study on the use of PS in children. The purpose of this study is to evaluate prospectively the value of PS to prevent the first hemorrhage from esophageal varices in children with portal hypertension and to assess the effect of PS on survival rate. METHODS: In a controlled, prospective, computer-based randomized trial, the effectiveness of PS was analyzed in 100 consecutive children allocated to a group receiving sclerotherapy (n = 50) or to a control group (n = 50) subjected only to regular clinical and endoscopic examinations. Clinical characteristics in both groups were similar. The minimum follow-up period was at least 18 months after the cessation of the sessions of sclerotherapy. RESULTS: After a median follow-up of 4.5 years, PS eliminated the esophageal varices in 47 of 50 (94%) patients but only 38 (76%) of them do not present upper digestive hemorrhage. Before complete obliteration of the varices, upper gastrointestinal bleeding occurred in 12 patients (24%). Six children (12%) had gastric varices, 3 of 6 of whom (50%) bled. Congestive hypertensive gastropathy was observed to occur in 8 (16%) patients, 4 of 8 of which (50%) had hemorrhagic episodes. Two patients bled from undetermined cause. In the control group, only 29 (58%) children remained free from esophageal variceal bleeding and 26 (52%) from any upper gastrointestinal bleeding (P<.05). During the follow-up period, the development of gastric varices was observed in 5 (10%) patients (P>.05) and of congestive hypertensive gastropathy in only 3 (6%) patients (P<.05), but none of them bled. PS does not improve survival rate. CONCLUSIONS: In children with cirrhotic and noncirrhotic portal hypertension, PS reduces the overall incidence of bleeding from esophageal varices that were eradicated in 94% of cases. The source of bleeding has been different in each group, being predominantly from esophageal varices in the control group and from the stomach in the prophylaxis group. When applied with appropriate technique, PS is a safe procedure with a low incidence of minor complications. PS does not change the incidence of gastric varices but increases the development of congestive hypertensive gastropathy. PS increases the risk of bleeding from the naturally formed gastric varices and from congestive hypertensive gastropathy. PS does not affect survival rate.     

Preliminary results of an uncemented trabecular metal tibial component in total knee arthroplasty

Trabecular metal has several theoretical advantages for the long-term survival of a tibial component. We report the results of a prospective cohort of 105 consecutive primary total knee arthroplasties using an uncemented trabecular metal (tantalum) tibial component at a minimum 3-year follow-up (range, 36-56 months). There was a significant improvement in Oxford Knee scores and Short Form-12 scores postoperatively. There was no radiolucency at the implant-bone interface on any postoperative radiograph. There has been one (1%) revision of the tibial component for trauma. The 3-year results using this prosthesis are as good as those published for the commonly used cemented prostheses. Longer follow-up is required to see whether these results are maintained over time.     

Sustainable effect of skin stretching for burn scar excision: long-term results of a multicenter randomized controlled trial

Purpose

Primary wound closure of large defects after burn scar excision may be facilitated by intraoperative stretching of the adjacent skin. In a randomized controlled trial (RCT), the effect of skin stretching for wound closure after scar excision (SS) was compared to scar excision without additional techniques (SE). Short-term results already showed that in the SS group larger scars could be excised in a one-step procedure. In this paper, the long-term scar outcome using reliable and valid measurement tools was evaluated.

Basic procedures

The percentage of total remaining scar area (i.e. remaining scar compared to preoperative scar), the percentage of linear scarring (i.e. surface area of linear scar compared to excised scar) and scar hypertrophy was measured at 3 and 12 months postoperatively.

Main findings

At 12 months postoperatively, the percentage of total remaining scar area was significantly lower in the SS group (26%) compared to the SE group (43%). The percentage of linear scarring (SS: 21%, SE: 25%) and the incidence of hypertrophy (SS: 29%, SE: 40%) were not significantly different between the treatment groups.

Conclusions

This RCT demonstrates the long-term beneficial and sustainable effect skin stretching for wound closure after scar excision without leading to wider linear scars or more scar hypertrophy.     

Stapled vs excision hemorrhoidectomy: long-term results of a prospective randomized trial

HYPOTHESIS: Stapled hemorrhoidectomy offers several advantages over excision hemorrhoidectomy, including reduced postoperative pain, a reduced hospital stay, and an earlier recovery time. Furthermore, stapled hemorrhoidectomy is associated with lower hemorrhoidal recurrence on long-term follow-up. DESIGN: A randomized prospective trial. Patients were blinded to the operation technique used. Follow-up occurred at 1 and 3 weeks and 12 months postoperatively. SETTING: A university hospital providing primary, secondary, and tertiary care. PATIENTS: Forty patients with second- and third-degree hemorrhoid disease were randomized to undergo either stapled or excision hemorrhoidectomy. Two patients were excluded. All patients were subject to a follow-up examination. INTERVENTIONS: Stapled hemorrhoidectomy (Longo technique) vs excision hemorrhoidectomy (Ferguson technique). MAIN OUTCOME MEASURES: Operating time, postoperative pain (measured by the visual analog scale), hospital stay, histologic features, morbidity, defecation habit, continence, recovery time (return to work), and hemorrhoid recurrence at 1 year. RESULTS: Stapled vs excision hemorrhoidectomy was associated with a significantly reduced operating time (30 vs 43.25 minutes; P<.001), reduced postoperative pain scores (visual analog score) on the first 4 postoperative days (day 1: 2.7 vs 6.3; day 2: 1.7 vs 6.3; day 3: 0.8 vs 5.4; and day 4: 0.5 vs 4.8, where 0 indicates no pain, and 10, maximum pain; P < or = .001), and an earlier return to work (6.7 vs 20.7 days;P =.001). There were no differences for stapled vs excision hemorrhoidectomy in length of hospital stay (2.4 vs 2.1 days), complications (3 [15%] of 20 patients vs 5 [25%] of 20 patients), and recurrence rate (1 [5%] of 20 patients vs 1 [5%] of 20 patients). CONCLUSIONS: Stapled hemorrhoidectomy is associated with reduced postoperative pain, earlier recovery time and return to work, and a similar recurrence rate compared with the excision technique. Provided further clinical trials confirm these findings, stapled hemorrhoidectomy may become a future gold standard.     

Robot-assisted versus conventional laparoscopic fundoplication: short-term outcome of a pilot randomized controlled trial

Background

Robotic technology represents the latest development in minimally-invasive surgery. Nevertheless, robotic-assisted surgery seems to have specific disadvantages such as an increase in costs and prolongation of operative time. A general clinical implementation of the technique would only be justified if a relevant improvement in outcome could be demonstrated. This is also true for laparoscopic fundoplication. The present study was designed to compare robotic-assisted (RALF) and conventional laparoscopic fundoplication (CLF) with the focus on operative time, costs und perioperative outcome.

Methods

Forty patients with gastro-esophageal reflux disease were randomized to either RALF by use of the daVinci^® Surgical System or CLF. Nissen fundoplication was the standard anti-reflux procedure. Peri-operative data such as length of operative procedure, intra-and postoperative complications, length of hospital stay, overall costs and symptomatic short-term outcome were compared.

Results

The total operative time was shorter for RALF compared to CLF (88 vs. 102 min; p = 0.033) consisting of a longer set-up (23 vs. 20 min; p = 0.050) but a shorter effective operative time (65 vs. 82 min; p = 0.006). Intraoperative complications included one pneumothorax and two technical problems in the RALF group and two bleedings in the CLF group. There were no conversions to an open approach. Mean length of hospital stay (2.8 vs. 3.3 days; p = 0.086) and symptomatic outcome thirty days postoperatively (10% vs. 15% with ongoing PPI therapy; p = 1.0 and 25% vs. 20% with persisting mild dysphagia; p = 1.0) was similar in both groups. Costs were higher for RALF than for CLF (€ 3244 vs. € 2743, p = 0.003).

Conclusion

In comparison with CLF, operative time can be shorter for RALF if performed by an experienced team. However, costs are higher and short-term outcome is similar. Thus, RALF can not be favoured over CLF regarding perioperative outcome.

     

Marsupialization of fistulotomy and fistulectomy wounds improves healing and decreases bleeding: a randomized controlled trial

BACKGROUND: Marsupialization of anal fistulotomy/fistulectomy wound leaves less raw unepithelialized tissue. The suture results in a more rapid healing and is likely to reduce the risk of bleeding but at the cost of an increased pain and infection. The aim of this prospective study was to compare the outcomes of marsupialization and open wound. METHODS: Forty-six consecutive patients with anal fistulae were recruited in a randomized controlled trial. Fistula tracks were treated by fistulotomy and/or fistulectomy. The resulting wounds were marsupialized to the skin edges with locking continuous absorbable sutures (M group) or left open (O group). The clinical outcome was then evaluated. The intra-operative effect of the suture on wound size was recorded as well as the postoperative pain using a 0-10 visual analogue scale (VAS) and the occurrence of both wound bleeding and infection. RESULTS: Twenty-two patients were randomized to the M group and 24 to the O group. There were no differences in the age, sex and fistula type between the groups. Mean follow-up times were 10.5 and 13.8 months, respectively. No significant difference was observed in postoperative pain, the VAS being 3.5 +/- 1.5 in the M group and 3.4 +/- 1.6 in the O group at 12 h (mean +/- s.e.m.; n.s). The marsupialization nearly halved the size of the wound intra-operatively from an area of 1749 +/- 66 mm2 to 819 +/- 38 mm2 (P < 0.001), which subsequently decreased to 217 +/- 15 mm2 after 4 weeks (P < 0.01). No significant reduction of wound size was observed in the O group (from 1171 +/- 31 mm2 to 543 +/- 19; n.s). Bleeding occurred less frequently in M group than in O group (36%vs 46%, P < 0.05), whereas the difference in the postoperative sepsis rate was not significant, being 14% in M vs 21% in the O group. Three reinterventions were needed in both groups due to wound sepsis. CONCLUSION: Marsupialization after fistulotomy/fistulectomy significantly reduces the size of the wound and the risk of bleeding, without increasing postoperative pain and sepsis.     

Migration of the uncemented Echo Bi-Metric and Bi-Metric THA stems: a randomized controlled RSA study involving 62 patients with 24-month follow-up

Background and purpose — Despite the good results after total hip arthroplasty (THA), new implants are continuously being developed to improve durability. The Echo Bi-Metric (EBM) THA stem is the successor to the Bi-Metric (BM) THA stem. The EBM stem includes many of the features of the BM stem, but minor changes in the design might improve the clinical performance. We compared the migration behavior with radiostereometric analysis (RSA) of the EBM stem and the BM stem at 24 months and evaluated the clinical outcome.Patients and methods — We randomized 62 patients with osteoarthritis (mean age 64 years, female/male 28/34) scheduled for an uncemented THA to receive either an EBM or a BM THA stem. We performed RSA within 1 week after surgery and at 3, 6, 12, and 24 months. The clinical outcome was evaluated using Harris Hip Score (HHS) and Oxford Hip Score (OHS).Results — At 24 months, we found no statistically significant differences in migration between the two implants. During the first 3 months both the EBM and the BM stems showed visible subsidence (2.5 mm and 2.2 mm respectively), and retroversion (2.5° and 2.2° respectively), but after 3 months this stabilized. The expected increase in HHS and OHS was similar between the groups.Interpretation — The EBM stem showed a migration at 24 months not different from the BM stem, and both stems display satisfying clinical results.

To improve the longevity of total hip arthroplasty (THA) new designs are continuously being developed. The introduction of new implants should optimally be done by phased stepwise introduction (Malchau 1995, Nelissen et al. 2011) including radiostereometric analysis (RSA) of implant migration.Some subsidence of hip stems is generally accepted within the first 3 months, but after that osseointegration and stability should have occurred. Mean subsidence of up to 1 mm of the stem at 24 months has been reported (Nysted et al. 2014, Weber et al. 2014, Hoornenborg et al. 2018, Sesselmann et al. 2018, Kruijntjens et al. 2020).This study investigates by RSA potential differences in migration at 24 months, between 2 different designs of porous-coated uncemented hip prosthesis; the Bi-Metric Full Proximal Profile THA stem (BM) and the Echo Bi-Metric (EBM) stem (Zimmer Biomet, Warsaw, IN, USA) (Figure 1). Both stems are press-fit titanium alloy stems with a proximal plasma spray porous titanium coating and a distal part with a roughened titanium surface. The BM has shown good clinical results and excellent stem survival in register studies since its introduction in 1984 (Jacobsen et al. 2003, Davies et al. 2010, Mäkelä et al. 2010, Lazarinis et al. 2011). The EBM is the successor to the BM and has 3 theoretical design improvements: a slimmer design of the neck to increase range of motion; a polished bullet-shaped distal tip to reduce distal stress; and an extended porous coating to support biological ingrowth proximally. Evaluation of adaptive bone remodeling and stress shielding will be addressed in another publication.Open in a separate windowFigure 1.The stems: on the left the Bi-Metric stem and on the right the Echo Bi-Metric stem.We hypothesized that the migration of the EBM was less at 24 months, compared with the BM stem.     

Preoperative bone mineral density of the proximal tibia and migration of the tibial component after uncemented total knee arthroplasty

Twenty-two patients with primary osteoarthrosis of the knee all operated on with insertion of an uncemented total knee arthroplasty had a preoperative measurement of bone mineral density (BMD) in the coronal plane of the proximal tibia performed by dual-photon absorptiometry. Postoperatively and with follow-up after 6 weeks (n = 21), 1 year (n = 22), and 3 years (n = 19), radiographs suitable for radiostereometric analysis of the tibial component migration were obtained. One year postoperatively, stress examinations were performed with the aim of measuring inducible displacement of the tibial component. Most of the migration, expressed as maximal total point motion (MTPM), occurred during the first year with an average migration of approximately 1 mm. Regression analysis showed a positive relation between BMD and MTPM after 6 weeks (P = .03, r = .47), 1 year (P = .0005, r = .68), and 3 years (P = .02, r = .54). Inducible displacement did not reveal any significant relation to BMD. MTPM between 1 and 3 years, which is the clinically most important parameter with respect to later loosening of the tibial component, showed a negative relation to BMD (P = .04, r = −.47). Thus, tibial components of knees with preoperative high tibial BMD showed less continuous migration.     

A randomized controlled trial comparing a modified Burch procedure and a suburethral sling: long-term follow-up

The aim of this study was to compare the long-term results of a modified Burch procedure with a sling procedure for the treatment of stress incontinence with a low-pressure urethra. Thirty-six women with urodynamic stress incontinence, low-pressure urethra, urethral hypermobility and no significant pelvic organ prolapse were randomly assigned to undergo either a modified Burch procedure (n=19) or a sling placement (n=17). Cure of the stress incontinence (defined as a negative stress test and negative pad-weight test) was the primary long-term endpoint. Secondary endpoints included subjective cure of stress incontinence (defined as no incontinence episodes on a 1-week voiding diary) and voiding function studies. Comparisons of group means were performed with the Mann–Whitney U-test, pooled variance t-tests and separate variance t-tests. Proportions were compared with Fisher's exact test. A logistic regression analysis was performed to control for covariates that differed in our two groups despite randomization. Long-term follow-up (mean=72.6 months) was available for 82% (28/34) of the original study group. The objective cure rates for the Burch and sling groups were 84.6% and 100%, respectively (P=0.17). Mean uroflowmetry rates for the Burch and sling groups were 7.38 and 6.8 ml/s, respectively (P=0.58, 95%CI –2.5, 4.4). Mean postvoid residual volumes for both groups were 35 ml (P=0.97, 95% CI –23.8, 65.9). Two sling patients (12%) required partial resection of their slings because of erosion. Both patients remained continent. In terms of voiding function and stress incontinence cure, there were no differences between groups undergoing modified Burch or sling procedures for treatment of urodynamic stress incontinence with low-pressure urethra.Abbreviations SI Stress incontinence - UI Urge incontinencePresented at the American Urogynecologic Society 21st Annual Scientific MeetingEditorial Comment: The authors have to be congratulated on their effort to provide evidence-based results. They used different techniques to perform the Burch procedure from used in the 1987 paper, and compared it to another technique they no longer use. Their power calculation is based on unsatisfactory results reported in 1987 for the Burch colposuspension. These results made the difference in outcome, thereby decreasing the number of subjects needed for the study. In addition, they did not report results as ITT. In spite of these shortcomings the study provides clinically useful data that can be built on for future research. I find it interesting that the super-Burch is good for low-pressure urethras, contrary to the belief that excessive tension can lead to ISD.     

New supraglottic airway with built-in pressure indicator decreases postoperative pharyngolaryngeal symptoms: a randomized controlled trial

Purpose

Excessive supraglottic airway cuff pressure increases postoperative pharyngolaryngeal symptoms such as sore throat, dysphonia, and dysphagia. A new supraglottic airway, AES Ultra CPV? (CPV), has a built-in intracuff pressure indicator. We hypothesized that using the CPV would reduce postoperative symptoms when compared with the LMA Classic? (LMA) without intracuff pressure guidance.

Methods

Ambulatory patients undergoing general anesthesia were randomized to either CPV or LMA. A size 3/4/5 was inserted according to manufacturer guidelines. Nitrous oxide was not used. In the LMA Group, the cuff was inflated according to manufacturer’s guidelines. In the CPV Group, a CPV was inserted and the cuff inflated until the indicator was in the green zone (30-44 mmHg). Intracuff pressures were measured at five minutes and 20 min post-insertion in both groups. The primary outcome was the incidence of pharyngolaryngeal symptoms, defined as sore throat, dysphonia, and/or dysphagia at one, two, and/or 24 hr postoperatively. Continuous data were compared using Student’s t test and categorical data were analyzed using Chi square analysis.

Results

The study included 170 patients, 85 per group. The mean (SD) intracuff pressure in the CPV group was significantly lower [44 (4) mmHg] than in the LMA Group [87 (37) mmHg]; P < 0.001. The incidence of pharyngolaryngeal symptoms was significantly lower in the CPV Group than in the LMA Group (26% vs 49%; P = 0.002). The absolute risk reduction was 24%, and the number-needed-to-treat was 4.3.

Conclusion

The incidence of postoperative pharyngolaryngeal symptoms in the CPV Group with a cuff pressure-guided strategy was significantly lower than in the LMA Group with standard practice. (Clinical trial registration number: NCT01800344).     

Transobturator versus single incision slings: 1-year results of a randomized controlled trial

Introduction and Hypothesis

To compare 1-year surgical outcomes following transobturator (TO) sling placement and single incision (SI) sling placement for the treatment of stress urinary incontinence (SUI).

Methods

We performed a randomized trial at a single institution. Patients with urodynamically proven SUI were offered participation and randomized to placement of a TO sling (Monarc?) or a SI sling (MiniArc?) between 2008 and 2011. The primary outcome measure was urinary leakage during standardized cough stress test (CST). Forty subjects in each group were required to achieve 80 % power to detect an effect size of 0.25.

Results

A total of 98 patients were randomized with 49 patients in the TO group and 49 patients in the SI group. Preoperative demographics were similar between the groups (Table 1). The TO group had a significantly longer sling operative time (10.7?±?4.8 min vs. 7.8?±?4.9 min, p?<?0.001) and greater estimated blood loss (31.6?±?26.6 mL vs. 22.9?±?22.1 mL, p?=?0.02). At the 1-year follow-up, there was no difference in the primary outcome with 9 TO patients (21 %) and 12 SI patients (29 %) having a positive CST (p?=?0.5). A composite measurement of ‘failure’, defined as patient-reported SUI and a positive CST, showed no difference between the TO group (17 %) and the SI group (27 %; p?=?0.3).

Conclusions

The SI sling provides comparable objective efficacy to the TO sling at 1 year.