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A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial
Background
Venous leg ulcers are slow-healing wounds with a high recurrence rate of 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the healthcare system and society in general. The estimated leg ulcer prevalence in the general population is 1%. Treatment costs for leg ulcers are estimated to be 3% of overall health expenditure. Current therapeutic approaches are multifaceted and include compression therapy, leg elevation, specific ankle-exercises and a protein diet. They require an interdisciplinary team of health care professionals. Approximately 70% of patients have a knowledge deficit with regards to therapeutic measures and have difficulties with adherence to treatment protocols. Therefore, it is of utmost importance that the treatment team provides effective patient education and support during the learning phase. However, there is little evidence and no published studies that describe and evaluate effective interdisciplinary educational interventions that target compliance/adherence to the treatment plan in patients with leg ulcers. We therefore propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trial.
Method/Design
First, the development of an evidence-based educational intervention in collaboration with an expert panel is proposed and second, a randomized controlled feasibility study in a wound-care outpatient clinic. Eligible patients (
n
= 20) with leg ulcers will be randomized to receive either interdisciplinary education and usual care or only usual care, for 12 weeks. Data will be analyzed using SPSS version 25. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data.
Discussion
We will first develop an evidenced-based educational intervention and second, we will examine the feasibility of implementing this educational intervention in a realistic care context in patients with leg ulcers. The results will inform the final design of a subsequent randomized controlled trial, which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy would be beneficial to individual patients and to society as a whole.
Trial registration
ClinicalTrials.gov,
NCT03454698
. Registered on 6 March 2018.
Journal Article
Animal legs
\"Can you smell with your feet? Do you dig your claws into a river's muddy bank to climb up and bask in the sun? Animals' legs are different from humans' in so many ways! Find out why strong talons suit a raptor, or webbing is perfect for water dwellers as author Mary Holland continues her photographic Animal Anatomy and Adaptations series by exploring the ways insects, amphibians, reptiles, and mammals move and explore their world.\"-- Provided by publisher.
Book
Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia
Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation.
We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure.
We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported.
We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).
Journal Article
Knockin' on wood : starring Peg Leg Bates
Presents a picture book biography of Clayton \"Peg Leg\" Bates, an African American who lost his leg in a factory accident at the age of twelve and went on to become a world-famous tap dancer.
Book
Radiographic evaluation of robot-assisted versus manual total hip arthroplasty: a multicenter randomized controlled trial
BackgroundThe effectiveness of robot-assisted surgery remains contentious due to the lack of high-quality randomized controlled trials (RCTs) to elevate the level of evidence. We aimed to evaluate the postoperative radiographic outcomes of robot-assisted (RAS-THA) versus manual (M-THA) total hip arthroplasty.MethodsThis multicenter RCT was performed from March 1, 2021 to December 1, 2021. Patients were randomly assigned to routine M-THA or to RAS-THA that used the TRex-RS orthopedic joint surgical navigation system. The primary outcome was to compare the acetabular component orientation, femoral stem alignment, femoral canal fill ratio, and leg length discrepancy between RAS-THA and M-THA using postoperative radiography. Subgroup analyses of the two groups stratified by surgical approach, gender, and BMI were also conducted.ResultsSeventy-three participants were randomly allocated to the RAS-THA group, while seventy-two participants were assigned to the M-THA group. Compared to the M-THA group, the RAS-THA group exhibited less variability in the preoperative planning of the vertical center of rotation (VCOR; P < 0.001), demonstrated a significant advantage in femoral stem alignment (P = 0.004), and showed pronounced decreases in inequality and in the variability in leg length discrepancy (P < 0.001). There was no significant difference in the Lewinnek safe-zone ratio (P = 0.081) and the femoral canal fill ratio (P > 0.05) between the two groups. Further subgroup analysis also showed that the RAS-THA group had fewer horizontal center of rotation (HCOR) and leg length differences when stratified by surgical approach, gender, and overweight status.ConclusionThis RCT found that, regardless of the surgical approach, gender, or body mass index, RAS-THA can effectively improve the postoperative VCOR and significantly reduce the variability of leg length difference. RAS-THA should be considered an effective method to enhance surgical precision by achieving less variability in challenging patients with leg length discrepancies.Trial registration: ChiCTR2100044124.
Journal Article
Forgotten joint score is worse when the affected leg perceived longer than shorter after total hip arthroplasty
Background
One of the causes of patient dissatisfaction after total hip arthroplasty (THA) is leg length discrepancy (LLD). Even when radiographic LLD (R-LLD) is within 5 mm, some people perceive the affected side to be longer, while others perceive it is shorter. The purpose of this study was to investigate the relationship between perceived LLD (P-LLD), R-LLD, and Forgotten Joint Score (FJS-12) after THA.
Methods
A retrospective study of 164 patients with unilateral hip disease was conducted. Based on P-LLD after THA, they were classified into three categories: perceived short (PS 21 patients), no LLD (PN 121 patients), and perceived long (PL 22 patients). On the other hand, based on R-LLD after THA, they were divided into < − 5 mm (RS 36 patients), − 5 mm ≤ x < 5 mm (RN 99 patients), and 5 mm ≥ (RL 29 patients), respectively. The proportion of P-LLD in the RN group was also evaluated. In each group, the relationship between P-LLD, R-LLD and FJS-12 was investigated.
Results
After THA, the PL group had significantly worse FJS-12 (PS: 68.3 ± 26.2, PN: 75.0 ± 20.9, PL: 47.3 ± 25.2,
P
< .0001). In the R-LLD evaluation, there was no difference in FJS-12 among the three groups (RS: 73.7 ± 21.1, RN: 70.0 ± 24.5, RL: 67.7 ± 25.4,
P
< .53). The RN group perceived leg length to be longer (RN-PL) in 12.1% of cases, and the RN-PL groups had significantly worse FJS-12 (RN-PS: 65.4 ± 24.8, RN-PN: 73.8 ± 23.1, RN-PL: 41.8 ± 27.6,
P
< .0001).
Conclusion
One year after THA, patients with longer P-LLD had worse FJS-12, even if the R-LLD was less than 5 mm.
Journal Article
Relationship between leg length discrepancy and functional scoliosis in children and adolescents
Purpose
As the relationship between leg-length discrepancy (LLD) and scoliosis has not been clearly defined, the purpose of this study was to explore the impact and severity of LLD in children and adolescents with scoliosis and the consistency between lower limb length discrepancy and pelvic height difference.
Methods
This retrospective study was conducted using prospectively collected data from 63 patients with functional scoliosis-associated LLD who received treatment at our hospital from March 2021 to July 2024. The inclusion criteria included: ①Children or adolescents with functional scoliosis complicated with LLD; ②Scoliosis classified as thoracolumbar or lumbar curve; ③A bilateral acetabular dome line parallel to the superior sacral endplate. The patients’ whole-spine posteroanterior and full lower limb radiographs were obtained to collect data on age, sex, LLD, Cobb angle, and pelvic height difference. Correlation analysis evaluated the relationship between LLD, leg-length discrepancy ratio (LLDR), Cobb angle, and the pelvic height difference. Univariate regression analysis was used to analyze the data using the SPSS software.
Results
In all cases, the convex side of the scoliosis corresponded to the shorter leg side. Female patients constituted 67% of the cohort. The patients’ mean age was 11.79 ± 3.52 years (range: 4 to 19 years). The average Cobb angle was 14.78 ± 4.99°, the average LLD was 11.22 ± 12.74 mm, and the mean pelvic height difference was 12.41 ± 10.32 mm. Significant correlations were observed when the bilateral acetabular dome line was parallel to the superior sacral endplate, and the scoliosis was thoracolumbar or lumbar, indicating associations between LLD and the Cobb angle (
R
= 0.440,
P
<0.05) and between LLDR and the Cobb angle (
R
= 0.445,
P
<0.05). Additionally, a strong positive correlation was identified between LLD and pelvic height difference (
R
= 0.874,
P
<0.05), indicating a high level of concordance between pelvic height difference and LLD.
Conclusions
In children and adolescents with functional scoliosis complicated by LLD, the Cobb angle significantly correlated with LLD. Additionally, LLDR also showed a significant correlation with the Cobb angle. A concordance was also observed between the pelvic height difference and LLD.
Clinical trial number
Not applicable.
Journal Article