Can a well balanced soft tissue envelope speed up the postoperative treatment and improve clinical follow-up? A control - pilot study using a dynamic ligament balancing device based on functional stability

IntroductionWorldwide, the number of TKA implants is increasing. Even if registry demonstrate that TKA as high satisfaction rate, there are still between 15 and 20% dissatisfied patients.Materials and methodsThe proper soft tissue balancing is one of the most discussed topics of the last years. We initiated a study using an electronic device („dynamic ligament balancing sensorplate“) to compare the benefit of the measurement of ligament tension, space and position in comparison to a conventional surgical procedure. Beside that, we followed the concept of functional stability, which tells us, that a tension of 40N in total is sufficient to reach proper (functional) joint stability.This control pilot study was set up as a single surgeon, single center study and consists of 25 patients treated by the use of the sensorplate and a control group of 25 patients, treated in a conventional setup.We used the following scores for evaluation: OKS, AKSS and FJS, preoperatively and during the FU examinations (postoperative, 6 weeks, 3 months, 6 months and 1 year)Beside scoring, clinical examination and routine x-ray we performed an EMG testing at all FU dates.ResultsThe study was performed between January 2017 and May 2019. The mean age of the patients was in average 72 years, 66 % female and 34 % male. After 1 year, results demonstrate a clear difference in the development of the postoperative situation between dynamic balanced TKA and the control one.So, the use of such electronic device improving the soft tissue envelope stability, enable a significantly better patient FU, especially in terms of OKSDiscussionThe DLB system is a new option to value and improve the soft tissue envelope tensioning during the surgical TKA operation. It allows to measure ligament tension, slope and joint space all over the entire ROM.ConclusionUsing an electronic device for measurement is an advanced option to improve patient satisfaction after tka. Like the studies of other existing devices have shown before there is a massive change in the kinematic behaviour of the muscular abilities by using these tools for a better soft tissue balance. The DLB system is another option by showing 3 different measurement results (tension, distance and joint angle) to adapt the implantation procedure to the individual situation of the patient.

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Optimizing TKA Positioning via Intraoperative Ligament Characterization

10.29007/6kb5 ◽

2020 ◽

Author(s):

Alexander Orsi ◽

Edgar Wakelin ◽

Sami Shalhoub ◽

Jeffrey Lawrence ◽

Corey Ponder ◽

...

Keyword(s):

Soft Tissue ◽

Transition Point ◽

Load Cycle ◽

Patient Specific ◽

Specific Method ◽

Joint Force ◽

Soft Tissue Envelope ◽

Tibial Resection ◽

Ligament Tension ◽

Balancing Robot

The goal of total knee arthroplasty (TKA) is to position the prosthesis with a bal- anced soft tissue envelope throughout the flexion cycle. Determining a desirable amount of ligament tension is crucial as instability is a leading cause for revision surgery. This is challenging due to the subject specific, and non-linear, nature of ligament mechanical properties. This study aims to characterize ligament stiffness profiles intraoperatively and identify the stiffness transition point (STP) using a ligament balancing robot. The study will also identify how the surgeon selected joint force relates to the stiffness transition point.45 patients were reviewed. After the proximal tibial resection, intraoperative assessment of the medial and lateral ligaments was performed via a load cycle ramped up from 50N to 120N, then down from 120N to 50N. This was performed at extension (10◦) and in flexion (90◦). Force and displacement data were processed to determine the stiffness profiles for the medial and lateral soft tissue envelope. A bilinear fit model was used to determine the slopes and STP.The average STP was between 83N and 90N, varying widely with standard deviations approaching 14N. The median joint tension selected by the surgeon was 80N. On average the selected joint force was 3N to 8.9N below the STP.The medial compartment behaved similarly in extension and flexion. The lateral com- partment had higher stiffness in extension than in flexion. Across all loading conditions, the down-cycle data was more consistent than the up-cycle data.The STP is a proposed target for ligament tension as this theoretically avoids the high stiffness regime. The results show the joint tension selected by the surgeons, based on their experience and intraoperative feel, is similar to the STP. Due to the high patient variability observed in the STP, using a patient specific method to determine the joint tension is recommended. Future work will investigate how joint tension relative to the STP affects patient outcomes. This will provide insight into optimizing joint tension during TKA.

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Personalized Behavioral Nutrition Intervention in Older Asian Americans with Type 2 Diabetes during COVID-19 Pandemic: Study Protocol for a Pilot, Hybrid, Randomized Controlled Trial (Preprint)

10.2196/preprints.23522 ◽

2020 ◽

Author(s):

Jisook Ko ◽

Yan Du ◽

Rozmin Jiwani ◽

Chengdong Li ◽

Jing Wang

Keyword(s):

Type 2 Diabetes ◽

Clinical Trials ◽

Pilot Study ◽

Glycemic Control ◽

Asian Americans ◽

Control Group ◽

Management Approach ◽

Self Monitoring ◽

Behavioral Nutrition

BACKGROUND The COVID-19 pandemic has challenged the in-person-based self-management approach (i.e., face-to-face or group approach) of type 2 diabetes (T2D). Older adults with T2D, including Asian Americans (AAs), have experienced worsening of diabetes control due to various reasons, including uncertainty of continuous access to essential diabetes medications, devices, education, limited health literacy, as well as constant anxiety and stress. Hybrid clinical trials that incorporate virtual elements into the in-person-based study could provide these vulnerable populations with accessible and timely interventions OBJECTIVE The primary aims of this pilot study are to determine (1) the effect of personalized behavioral nutrition (PBN) intervention on glycemic control, weight control, and metabolites profiles; and (2) the acceptability of PBN. to enhance glycemic control using personalized behavioral nutrition. METHODS Participants will be recruited with a web-based registry, advertisements in ethnic newspapers, and social network services popular among AAs. A total of 60 AAs, aged 65 years or older, who are descendants of Chinese, Korean, or South Asian, and have a diagnosis of T2D will be randomized into two groups: a PBN group (n=30) and a control group (n=30). A 4-week PBN intervention comprises three components: 1) digital self-monitoring; 2) personal nutrition change goals and recommendations; and 3) diabetes nutrition educations. All participants will complete digital self-monitoring on diet, physical activity, and blood glucose. In addition, all participants will access an interactive digital platform to track their self-monitoring data and communicate with the research team. The effectiveness and acceptability of implementing the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in August 2020 and is ongoing. CONCLUSIONS To our knowledge, this is the first study to determine the effectiveness and acceptability of PBN utilizing a metabolomics approach and digital-assisted intervention with hybrid RCT among older AAs. The findings of this pilot study will inform the development of a full-scale PBN protocol and hybrid clinical trials that can be adapted for people with T2D in the ongoing pandemic.

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AB0007 STAT4 RS7574865 G/T POLYMORPHISM AS MARKER OF PREDISPOSITION TO SYSTEMIC LUPUS ERYTHEMATOSUS WITH JUVENILE ONSET

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2142 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1038.2-1039

Author(s):

M. Kaleda ◽

M. Krylov ◽

I. Nikishina

Keyword(s):

Systemic Lupus Erythematosus ◽

Pilot Study ◽

Lupus Erythematosus ◽

Renal Involvement ◽

Control Group ◽

Coombs Test ◽

Systemic Lupus ◽

Direct Coombs Test ◽

Positive Direct ◽

Cutaneous Lupus

Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a significant genetic predisposition. Recent studies have identified STAT4 (signal transducers and transcription activators 4) as a susceptibility gene for SLE.Objectives:To investigate the hypothesis of the association of STAT4 rs7574865 G/T polymorphism with the predisposition to SLE in children and its relationship with some of SLE manifestations.Methods:The case-control pilot study included 143 children (39 with SLE and 103 healthy unrelated volunteers as a control group). Diagnosis of SLE was based on 2012 SLICC criteria. STAT4 rs7574865 G/T polymorphism was investigated using allele-specific real-time polymerase chain reaction (RT-PCR).Results:The group of pts with SLE consisted of 29 girls and 10 boys, with an average age of 11.8±3.7 years (from 3 to 17 years) and an average disease duration of 4.1±2.4 years. 79.5% pts had acute cutaneous lupus at the onset, 46.1% - nonscarring alopecia, 71.8% - arthritis, 23.1% - oral and nasal ulcers, 23.1% - serositis, 43.6% - renal involvement, 35.9% –neuropsychiatric disorders. Leucopenia/lymphopenia was found in 71.8% of pts, thrombocytopenia – in 23,1%. ANA were detected in 100% pts, anti-dsDNA – in 79.5%, anti-Sm – in 31.6%, antiphospholipid antibodies - in 7,3%, hypocomplementemia – in 61.5%, positive direct Coombs test – in 35.9 %. Macrophage activation syndrome at the onset was documented in 15.4 % of pts. The distribution of rs7574865 genotypes in the control group showed no significant deviations from the Hardy-Weinberg equilibrium. The distribution of genotype frequencies among pts had statistically significant differences compared to the control (χ2=12.95, p=0.0015): GG-30.8% and 63.1% (p=0.001), GT-56.4% and 33.0% (p=0.018), TT-12.8% and 3.9% (p=0.114), GT+TT - 69.2% and 36.9% (p=0.0005). The frequency of the mutant STAT 4 allele T (polymorphism), was significantly higher in the SLE group than in the control group (41% and 20.4%, respectively; p=0.0007). We identified an association of the T allele with some clinical, laboratory, and immunological disorders in SLE: arthritis (OR 3.9, p=0.0002), acute cutaneous lupus (OR 2.47, p=0.003), nonscarring alopecia (OR 3.12, p=0.002), renal involvement (OR 2.42, p=0.022), leucopenia (OR 2.72, p=0.003), thrombocytopenia (OR 4.88, p=0.002), anti-dsDNA (OR 2.82, p=0.0006), hypocomplementemia (OR 2.34, p=0.012), positive direct Coombs test (OR 3.38, p=0.002).Conclusion:Our pilot study confirmed that the STAT4 rs7574865 G/T polymorphism was associated with the risk of SLE in children and some of SLE manifestations.Disclosure of Interests:None declared

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Does soft tissue mobilization assist static stretching to improve hamstring flexibility? A randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2019-0288 ◽

2020 ◽

Vol 0 (0) ◽

Cited By ~ 1

Author(s):

Shibili Nuhmani

Keyword(s):

Soft Tissue ◽

Controlled Trial ◽

Knee Extension ◽

Repeated Measure ◽

Control Group ◽

Static Stretching ◽

Significant Difference ◽

Hamstring Flexibility ◽

Soft Tissue Mobilization ◽

Experimental Group

AbstractObjectivesObjective of the study is to investigate whether Soft tissue mobilization (STM) can assist with static stretching to improve hamstring flexibly.MethodsThe design of the study was repeated measure design. The study was conducted at the physical therapy laboratory of Jamia Hamdard University, New Delhi. Participants included 78 healthy males with hamstring tightness, randomly assigned to either the control group (static stretching) or the experimental group (STM and static stretching). The experimental group received five sets of four different STM techniques, followed by two sets of 30-s static stretches 3 days per week over the course of 12 weeks. The control group received 5 min of sham ultrasound with an inactive probe prior to static stretching. Active knee extension test (AKE) was the outcome measure.ResultsBoth groups showed significant improvement in AKE compared with the baseline measurements. With ingroup analysis showed a significant difference in AKE across all measured time periods (weeks 4, 8, and 12) with pre-test in both groups (p<0.05). No significant difference in AKE improvement was found between groups (p>0.05).ConclusionThe results of this study show that STM prior to static stretching does not significantly improve hamstring flexibility among healthy individuals. Although this study cannot be generalized, the results may be useful for evidence-based practice in the management of hamstring tightness.

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FRI0617-HPR GRADED MOTOR IMAGERY IN POSTTRAUMATIC STIFFNESS OF THE ELBOW: A PILOT STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2660 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 913.2-914

Author(s):

T. Birinci ◽

E. Kaya Mutlu ◽

S. Altun

Keyword(s):

Pilot Study ◽

Motor Imagery ◽

Upper Limb ◽

Exercise Program ◽

Control Group ◽

Elbow Fracture ◽

Stiff Elbow ◽

Limb Fractures ◽

Upper Limb Fractures ◽

Graded Motor Imagery

Background:Elbow fracture is treated either conservatively or surgically followed by a period of immobilization with casting or splinting. A splint used to immobilize upper limbs for many weeks results in changes in both the peripheral musculature and the central nervous system. It is well known that common complaints after upper limb fractures include weakness, pain, and stiffness; therefore, pain management is important in the early stages of the rehabilitation of upper limb fractures.Objectives:This pilot study aimed to investigate the efficacy of graded motor imaginary (GMI) on pain, range of motion (ROM), and function in patients with posttraumatic stiff elbow.Methods:Fourteen patients with posttraumatic stiff elbow (6 women, mean age: 45.42 ± 11.26 years, mean body mass index: 24.29 ± 3.38 kg\m2and mean duration of immobilization: 4.75 ± 1.03 weeks) were randomly allocated to either GMI or control groups. The GMI group received GMI treatment in addition to a structured exercise program, and the control group received a structured exercise program (two days per week for six weeks) (Figure 1). The assessments included pain at rest and during activity using the visual analog scale (VAS), elbow active ROM with a digital goniometer (Baseline Evaluation Instrument, Fabrication Enterprises, Inc., White Plains, NY), and upper extremity functional status using the Disability of the Arm, Shoulder and Hand Questionnaire (DASH). The assessments were performed at baseline and after the 6-week intervention.Figure 1.Graded motor imagery performed with mirror boxResults:After the 6-week intervention, there was a significant increase in elbow flexion-extension ROM and supination-pronation ROM, and improvement in DASH score in both groups (p<0.05). However, improvement in VAS-rest and VAS-activity was significantly higher in the GMI group than the control group (p=0.03 and p=0.01, respectively).Conclusion:A conservative treatment program consisting of GMI treatment in addition to a structured exercise program applied twice a week for 6 weeks, has been found more effective in decreasing pain in the posttraumatic stiff elbow. It could be concluded that GMI is an effective treatment method for elbow fracture in patients with predominant elbow pain.References:[1] Harris JE, Hebert A. Utilization of motor imagery in upper limb rehabilitation: a systematic scoping review. Clin Rehab. 2015:29(11):1092-1107.[2] Opie GM, Evans A, Ridding MC, Semmler JG. Short-term immobilization influences use-dependent cortical plasticity and fine motor performance. Neuroscience. 2016:330:247-256.[3] Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehab. 2019:33(2):241-252.Acknowledgments:The present work was supported by the Scientific Research Projects Coordination Unit of Istanbul University-Cerrahpasa (Project No: TDK-2019-33997).Disclosure of Interests:None declared

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Parental Self-Efficacy to Promote Children’s Healthy Lifestyles: A Pilot and Feasibility Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18094794 ◽

2021 ◽

Vol 18 (9) ◽

pp. 4794

Author(s):

Cayetana Ruiz-Zaldibar ◽

Inmaculada Serrano-Monzó ◽

Olga Lopez-Dicastillo ◽

María Jesús Pumar-Méndez ◽

Andrea Iriarte ◽

...

Keyword(s):

Pilot Study ◽

Parenting Styles ◽

Self Efficacy ◽

Parenting Practices ◽

Healthy Lifestyle ◽

Intervention Group ◽

Positive Parenting ◽

Parenting Programs ◽

Control Group ◽

Healthy Lifestyles

Positive parenting programs are a key strategy to promote the development of parental competence. We designed a pilot study based on parental self-efficacy to promote healthy lifestyles in their children aged between 2 to 5 years old. In this pilot study, we aimed to assess the effects of a parenting program on parental self-efficacy and parenting styles. Twenty-five parents were allocated into intervention (N = 15) and control group (N = 10). Parents from the intervention group received four group sessions (120 mi per session) to develop a positive parenting, parenting styles and parenting skills regarding to children’s diet, exercise, and screen time, and two additional sessions about child development and family games. Parents from the control group received these two latter sessions. Parental self-efficacy, parenting styles, and meal-related parenting practices were measured before and after the intervention and at 3-month follow-up. Acceptability and feasibility of the program was also measured. Quantitative data were analyzed using the repeat measures ANOVA and ANCOVA tests and the effect size calculation. Content analysis was used to analyse open questions. Positive trends were found regarding parental self-efficacy and the use of authoritative parenting style. Parents also reported a great acceptability of the program getting high satisfaction. According to the feasibility barriers and facilitators aspects were identified. The positive trends founded in this study support the development of parenting programs to promote healthy lifestyle in children.

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Correlation between cytologic features and histologic grades in cutaneous and subcutaneous soft tissue sarcomas in dogs—A pilot study

Veterinary Clinical Pathology ◽

10.1111/vcp.12975 ◽

2021 ◽

Author(s):

Sonia Sanchez‐Redondo ◽

Cassia H. Z. Hare ◽

Fernando Constantino‐Casas ◽

Tim L. Williams

Keyword(s):

Pilot Study ◽

Soft Tissue ◽

Soft Tissue Sarcomas

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Cerebral oxygenation in 45-degree trendelenburg position for robot-assisted radical prostatectomy: a single-center, open, controlled pilot study

BMC Urology ◽

10.1186/s12894-020-00774-4 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Clemens Wiesinger ◽

Dominik Stefan Schoeb ◽

Mathias Stockhammer ◽

Emir Mirtezani ◽

Lukas Mitterschiffthaler ◽

...

Keyword(s):

Pilot Study ◽

Cerebral Oxygenation ◽

Preoperative Assessment ◽

Patient Characteristics ◽

Rank Test ◽

Control Group ◽

Robot Assisted ◽

Clinical Trial Registry ◽

Trendelenburg Position ◽

Signed Rank Test

Abstract Background Within the last decade, robotically-assisted laparoscopic prostatectomy (RALP) has become the standard for treating localized prostate cancer, causing a revival of the 45° Trendelenburg position. In this pilot study we investigated effects of Trendelenburg position on hemodynamics and cerebral oxygenation in patients undergoing RALP. Methods We enrolled 58 patients undergoing RALP and 22 patients undergoing robot-assisted partial nephrectomy (RAPN) (control group) in our study. Demographic patient data and intraoperative parameters including cerebral oxygenation and cerebral hemodynamics were recorded for all patients. Cerebral function was also assessed pre- and postoperatively via the Mini Mental Status (MMS) exam. Changes in parameters during surgery were modelled by a mixed effects model; changes in the MMS result were evaluated using the Wilcoxon signed rank test. Results Preoperative assessment of patient characteristics, standard blood values and vital parameters revealed no difference between the two groups. Conclusions Applying a 45° Trendelenburg position causes no difference in postoperative brain function, and does not alter cerebral oxygenation during a surgical procedure lasting up to 5 h. Further studies in larger patient cohorts will have to confirm these findings. Trial registration German Clinical Trial Registry; DRKS00005094; Registered 12th December 2013—Retrospectively registered; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005094.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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667 Effects of Sleep-Extend on glucose metabolism in women with a history of gestational diabetes: A pilot study

SLEEP ◽

10.1093/sleep/zsab072.665 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A261-A261

Author(s):

Sirimon Reutrakul ◽

Pamela Martyn-Nemeth ◽

Laurie Quinn ◽

Kirstie Danielson ◽

Brett Rydzon ◽

...

Keyword(s):

Physical Activity ◽

Pilot Study ◽

Glucose Metabolism ◽

Gestational Diabetes ◽

Sleep Duration ◽

Control Group ◽

Healthy Living ◽

Short Sleep ◽

History Of ◽

Sleep Extension

Abstract Introduction Experimental and epidemiological data have linked insufficient sleep to increased diabetes risk. Women with a history of gestational diabetes (GDM) have a 7-fold greater risk of developing type 2 diabetes. This pilot study explored the feasibility of a sleep extension intervention in women with a history of GDM and short sleep, and the effects on glucose metabolism. Methods Women age 18–45 years with a history of GDM (at least 1 year postpartum) and actigraphy confirmed short sleep duration (<7h/night) on weekdays were randomized at a ratio of 1 control (healthy living information) to 2 cases (6 weeks of “Sleep Extend” intervention: use of a Fitbit, weekly digital content, interactive tools, and coach delivered feedback in order to increase sleep duration). An oral glucose tolerance test (OGTT), 7-day actigraphy recording and questionnaires were obtained at baseline and 6 weeks (at the end of the intervention). Results Twelve women (mean (SD) age 40.3 (4.5) years) participated (n=8 Sleep Extend, n=4 control). Compared to baseline, nightly sleep duration increased in Sleep Extend group (+30.6 (48.8) minutes) but decreased in the control group (-6.8 (22.9) minutes). Both fasting and 2-h glucose levels from OGTT increased in both groups but were greater in the control group (Sleep extend vs. healthy living: fasting glucose +2.1 (9.8) vs. +12.8 (7.3) mg/dL; 2-h glucose +8.2 (21.9) vs. +20.0 (19.4) mg/dL). Self-reported sleep quality improved in both groups. When compared controls, Sleep Extend participants reported improved fatigue symptoms (Promis fatigue score change -5.1 (9.3) vs. 7.0 (1.0), p=0.008), and self-reported physical activity tended to increase (+1614 (3659) vs. -2900 (3922) MET-minutes/week). Combining all participants, an increase in sleep duration correlated with a decrease in fatigue (r= -.62, p=0.04) and anxiety symptoms (r= -.69, p=0.02). Conclusion Sleep extension through coaching and use of remote monitoring is feasible in women with a history of GDM. It appears to decrease fatigue and may improve glucose metabolism and physical activity. Support (if any) NIDDK P30 DK092949

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