scholarly journals Anatomic Repair vs Closed Reduction of the Syndesmosis

2021 ◽  
pp. 107110072199000
Author(s):  
Al-Walid Hamam ◽  
Moaz Bin Yunus Chohan ◽  
Christina Tieszer ◽  
Abdel-Rahman Lawendy ◽  
Christopher Del Balso ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Closed Reduction ◽  
Functional Outcomes ◽  
Open Reduction ◽  
Screw Fixation ◽  
Secondary Outcome ◽  
Level Of Evidence ◽  
Significant Difference

Background: The goal of the study was to compare radiographic and functional outcomes between conventional closed syndesmotic reduction and screw fixation with open reduction, direct repair of the anterior inferior tibiofibular ligament (AiTFL) and screw fixation. We hypothesized that open reduction with restoration of the AiTFL would provide an improved reduction with better radiographic and functional outcomes. Methods: Fifty consecutive patients with OTA 44-C ankle fractures were enrolled. Treatment was nonrandomized and based on surgeon preference. Patients were treated with either open reduction, suture-anchor AiTFL repair, and screw fixation (ART group), or conventional closed reduction of the syndesmosis followed by screw fixation (CR group). The primary outcome measure was anteroposterior (AP) displacement of the fibula on CT scan at 3 months postoperatively. Secondary outcome measures included the Maryland Foot Score, the American Orthopaedic Foot & Ankle Society (AOFAS) Ankle Hindfoot Score, and the Foot and Ankle Outcome Score (FAOS). Results: Mean AP difference between injured and noninjured ankles was decreased in the ART group compared with the CR group (0.7 ± 0.3 mm vs 1.5 ± 0.3 mm, P = .008). No differences were observed between groups in overall scores for secondary outcome measures. The ART group displayed a significant difference in Maryland Foot Shoe subscore at 12 months (ART = 9.5 vs CR = 8.3, P = .03) and FAOS Quality of Life subscore at 12 months (64.1 compared to 38.3, P = .04). Conclusions: Open anatomic syndesmotic repair resulted in improved radiographic outcomes compared with closed reduction. Cosmesis was worse at 6 weeks compared to the CR group; however, quality of life and shoewear were improved in the ART group at 1 year postoperatively. Level of Evidence: Level II, prospective comparative study.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

2019 ◽  
Vol 35 (5) ◽  
pp. 305-315 ◽  
Author(s):  
Sandip Nandhra ◽  
Tom Wallace ◽  
Joseph El-Sheikha ◽  
Daniel Carradice ◽  
Ian Chetter
Keyword(s):  
Quality Of Life ◽  
General Anaesthesia ◽  
Saphenous Vein ◽  
Primary Outcome ◽  
Great Saphenous Vein ◽  
Bodily Pain ◽  
Secondary Outcome ◽  
Surgical Ligation ◽  
Significant Difference

Introduction Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. Methods Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. Results A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20–54) mm vs. (GA alone) 56 (24–70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6–17.9) vs. 4.3 (IQR 2.7–7.9) P = 0.004). Conclusion The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39

A Prospective Randomized Controlled Study of Fixation of Long Oblique and Spiral Shaft Fractures of the Proximal Phalanx: Closed Reduction and Percutaneous Kirschner Wiring Versus Open Reduction and Lag Screw Fixation

2003 ◽  
Vol 28 (1) ◽  
pp. 5-9 ◽  
Author(s):  
T. C. HORTON ◽  
M. HATTON ◽  
T. R. C. DAVIS
Keyword(s):  
Grip Strength ◽  
Closed Reduction ◽  
Open Reduction ◽  
Screw Fixation ◽  
Kirschner Wire ◽  
Proximal Phalanx ◽  
Controlled Study ◽  
X Rays ◽  
Lag Screw ◽  
Significant Difference

Patients with an isolated spiral or long oblique fracture of the proximal phalanx were randomized into two groups. One was treated by closed reduction and Kirschner wire fixation and the second treated by open reduction and lag screw fixation. An independent observer assessed function, pain, movement, grip strength and intrinsic muscle function. X-rays were assessed for malunion. Thirty-two patients were entered the study and 15 in the Kirschner wire and 13 in the lag screw group were reviewed at a mean follow-up of 40 months. There was no significant difference in the functional recovery rates or in the pain scores for the two groups. X-rays showed similar rates of malunion and there were no statistically significant differences in range of movement or grip strength.

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals Acupuncture for Comorbid Mild-Moderate Depression and Chronic Musculoskeletal Pain: Study Protocol for A Randomized Controlled Trial

2021 ◽  
Author(s):  
sheng Li ◽  
Jing Liu ◽  
Jianpeng Huang ◽  
Ding Luo ◽  
Qian Wu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Effective Treatment ◽  
Musculoskeletal Pain ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Chronic Musculoskeletal Pain ◽  
World Health ◽  
Secondary Outcome

Abstract Background: Depression and Chronic musculoskeletal pain (CMSP) are the leading causes of global years lived with disability diseases. Moreover, they often commonly coexist, which made a great difficult to diagnosis and treatment. A safe and effective treatment was urgently need. Previous studies showed that acupuncture was a cost-effective treatment for simple depression or CMSP. But limited evidence showed that acupuncture was effective for depression comorbid CMSP. Methods: This is a randomized, sham acupuncture-controlled trial with three arms: real acupuncture (RA), sham acupuncture (SA) and healthy control (HC). 48 depression combined CMSP participants and 12 healthy people will be recruited from GDTCM hospital and randomized 2:2:1 to RA, SA, HC group. The patients will receive RA or SA intervention for 8 weeks, and HC will not receive any intervention. Upon completion of the intervention, there is a 4 weeks follow-up. The primary outcome measures will be severity of depression and pain which assessed by Hamilton depression rating scale (HAMD-17) and brief pain inventory (BPI), respectively. The secondary outcome measures will be cognitive function, and quality of life which measured by Montreal cognitive assessment (MoCA), P300 and world health organization quality of life (WHOQOL-BREF). In addition, the correlation between brain derived neurotrophic factor (BDNF) and symptoms will also be determined. Discussion: The aim of this study is to evaluate the clinic efficacy and underlying mechanism of acupuncture on depression comorbid CMSP. This study will provide a convenient and cost-effectively means for future prevention and treatment of combined depression and CMSP.Trial registration: This study pre-registered at 2th Feb 2018, at Chinese Clinical Trail Registry (ChiCTR1800014754). The study is on the recruiting status.

scholarly journals Effectiveness of a peer-mediated educational intervention in improving general practitioner diagnostic assessment and management of dementia: a cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021125 ◽  
Author(s):  
Dimity Pond ◽  
Karen Mate ◽  
Nigel Stocks ◽  
Jane Gunn ◽  
Peter Disler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
General Practices ◽  
Randomised Controlled

ObjectiveTest effectiveness of an educational intervention for general practitioners (GPs) on quality of life and depression outcomes for patients.DesignDouble-blind, cluster randomised controlled trial.SettingGeneral practices in Australia between 2007 and 2010.ParticipantsGeneral practices were randomly allocated to the waitlist (n=37) or intervention (n=66) group, in a ratio of 1:2. A total of 2030 (1478 intervention; 552 waitlist) community-dwelling participants aged 75 years or older were recruited via 168 GPs (113 intervention; 55 waitlist).InterventionsA practice-based academic detailing intervention led by a peer educator that included: (1) training in use of the GP assessment of cognition dementia screening instrument; (2) training in diagnosis and management based on Royal Australian College of General Practitioners Dementia Guidelines; (3) addressing GPs’ barriers to dementia diagnosis; and (4) a business case outlining a cost-effective dementia assessment approach.Outcome measuresPrimary outcome measures were patient quality of life and depression; secondary outcome measures were: (1) sensitivity and specificity of GP identification of dementia; (2) referral to medical specialists and/or support services; (3) patient satisfaction with care; and (4) carer quality of life, depression and satisfaction with care.ResultsThe educational intervention had no significant effect on patient quality of life or depression scores after 12 months. There were however improvements in secondary outcome measures including sensitivity of GP judgement of dementia (p=0.002; OR 6.0, 95% CI 1.92 to 18.73), satisfaction with GP communication for all patients (p=0.024; mean difference 2.1, 95% CI 0.27 to 3.93) and for patients with dementia (p=0.007; mean difference 7.44, 95% CI 2.02 to 12.86) and enablement of carers (p=0.0185; mean difference 24.77, 95% CI 4.15 to 45.40).ConclusionPractice-based academic detailing did not improve patient quality of life or depression scores but did improve detection of dementia in primary care and patient satisfaction with GP communication.Trial registration numberACTRN12607000117415; Pre-results.

scholarly journals Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
N. A. C. van den Boom ◽  
G. A. N. L. Stollenwerck ◽  
S. M. A. A. Evers ◽  
M. Poeze
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Internal Fixation ◽  
Study Protocol ◽  
Functional Outcomes ◽  
Open Reduction ◽  
Controlled Trial ◽  
Optimal Treatment ◽  
Fracture Dislocation

Abstract Background The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. Methods Study design: A prospective multicenter RCT. Study population: All patients of 18 years and older with an acute (< 6 weeks) traumatic fracture dislocation in the Lisfranc midfoot joints, displaced on static radiographic evaluation or unstable with dynamic evaluation, weight bearing radiographs or fluoroscopic stress testing under anesthesia, and eligible for either one of the surgical procedures. In total, this study will include n = 112 patients with Lisfranc fracture dislocation. Interventions: Patients with Lisfranc fracture dislocation will be randomly allocated to treatment in “The Better to Fix or Fuse Study” (The BFF Study) with either PA or ORIF. Main study parameters/endpoints: Primary outcome parameter: the quality of life. Secondary outcomes: complications, functional outcomes, secondary surgical interventions and cost effectiveness. Nature and extent of the burden: PA is expected to have a better outcome, however both treatments are accepted for this injury with a similar low risk of complications. Follow up is standardized and therefore this study will not add extra burden to the patient. Discussion This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic. Trial registration Current controlled Trial: NCT04519242 with registration date: 08/13/2020. Retrospectively registered; Protocol date and version: Version 4 05/06/2020

scholarly journals Exercise for People in Early- or Mid-Stage Parkinson Disease: A 16-Month Randomized Controlled Trial

2012 ◽  
Vol 92 (11) ◽  
pp. 1395-1410 ◽  
Author(s):  
Margaret Schenkman ◽  
Deborah A. Hall ◽  
Anna E. Barón ◽  
Robert S. Schwartz ◽  
Pamela Mettler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Parkinson Disease ◽  
Outcome Measures ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Home Based ◽  
Walking Economy

BackgroundExercise confers short-term benefits for individuals with Parkinson disease (PD).ObjectiveThe purpose of the study was to compare short- and long-term responses among 2 supervised exercise programs and a home-based control exercise program.DesignThe 16-month randomized controlled exercise intervention investigated 3 exercise approaches: flexibility/balance/function exercise (FBF), supervised aerobic exercise (AE), and home-based exercise (control).SettingThis study was conducted in outpatient clinics.PatientsThe participants were 121 individuals with PD (Hoehn & Yahr stages 1–3).InterventionsThe FBF program (individualized spinal and extremity flexibility exercises followed by group balance/functional training) was supervised by a physical therapist. The AE program (using a treadmill, bike, or elliptical trainer) was supervised by an exercise trainer. Supervision was provided 3 days per week for 4 months, and then monthly (16 months total). The control group participants exercised at home using the National Parkinson Foundation Fitness Counts program, with 1 supervised, clinic-based group session per month.MeasurementsOutcomes, obtained by blinded assessors, were determined at 4, 10, and 16 months. The primary outcome measures were overall physical function (Continuous Scale—Physical Functional Performance [CS-PFP]), balance (Functional Reach Test [FRT]), and walking economy (oxygen uptake [mL/kg/min]). Secondary outcome measures were symptom severity (Unified Parkinson's Disease Rating Scale [UPDRS] activities of daily living [ADL] and motor subscales) and quality of life (39-item Parkinson's Disease Quality of Life Scale [PDQ-39]).ResultsOf the 121 participants, 86.8%, 82.6%, and 79.3% completed 4, 10, and 16 months, respectively, of the intervention. At 4 months, improvement in CS-PFP scores was greater in the FBF group than in the control group (mean difference=4.3, 95% confidence interval [CI]=1.2 to 7.3) and the AE group (mean difference=3.1, 95% CI=0.0 to 6.2). Balance was not different among groups at any time point. Walking economy improved in the AE group compared with the FBF group at 4 months (mean difference=−1.2, 95% CI=−1.9 to −0.5), 10 months (mean difference=−1.2, 95% CI=−1.9 to −0.5), and 16 months (mean difference=−1.7, 95% CI=−2.5 to −1.0). The only secondary outcome that showed significant differences was UPDRS ADL subscale scores: the FBF group performed better than the control group at 4 months (mean difference=−1.47, 95% CI=−2.79 to −0.15) and 16 months (mean difference=−1.95, 95% CI=−3.84 to −0.08).LimitationsAbsence of a non-exercise control group was a limitation of the study.ConclusionsFindings demonstrated overall functional benefits at 4 months in the FBF group and improved walking economy (up to 16 months) in the AE group.

Functional Outcomes and Quality of Life in Elderly Patients after Restorative Proctocolectomy for Ulcerative Colitis

Digestion ◽  
2019 ◽  
Vol 101 (6) ◽  
pp. 737-742 ◽  
Author(s):  
Tomohiro Minagawa ◽  
Hiroki Ikeuchi ◽  
Ryuichi Kuwahara ◽  
Yuki Horio ◽  
Hirofumi Sasaki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Elderly Patients ◽  
Functional Outcomes ◽  
The Elderly ◽  
First Year ◽  
Significant Difference ◽  
Fecal Soiling

<b><i>Background/Aim:</i></b> Ileal pouch anal anastomosis (IPAA) has become the surgical procedure of choice for patients with ulcerative colitis (UC). However, to date few studies have examined functional outcomes or quality of life (QOL) in elderly patients after pouch construction. <b><i>Methods:</i></b> In December 2017, we sent questionnaires to 224 patients aged 65 years and older at the time who underwent an IPAA at our hospital between June 1987 and May 2015 regarding issues related to QOL and functional outcomes. Responders aged 65–69 years old were defined as the elderly group (EG), while those 70 years old and over comprised the super-EG (SEG). <b><i>Results:</i></b> The response rate was 60.7% (136/224); 70 patients were classified as EG, and 66 were classified as SEG. The SEG were older at the time of the IPAA and during the follow-up period (<i>p</i> &#x3c; 0.01). The stool frequency per day was 8 times in both groups (<i>p</i> = 0.21). There was no significant difference between the EG and SEG with regard to daytime (53 vs. 56%, <i>p</i> = 0.73) or nighttime (65.7 vs. 53%, <i>p</i> = 0.16) soiling. There was also no difference in the exacerbation of daytime or nighttime soiling compared to the first year after the operation (daytime 5.7 vs. 12.1%, <i>p</i> = 0.23; nighttime 7.1 vs. 9.1%, <i>p</i> = 0.76). QOL was evaluated using the modified fecal incontinence QOL (mFIQL) scale, with no significant difference between the EG and SEG (27 vs. 31 points). Since both groups had mFIQL scores &#x3c;50, QOL was considered to be maintained. <b><i>Conclusion:</i></b> In our analysis of elderly patients in the long-term period following surgery for UC, some noted fecal soiling, though QOL was largely maintained, and there were no serious effects on daily life.

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