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Fractures, Bone clinical trials

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NCT ID: NCT04707183 Not yet recruiting - Rib Fractures Clinical Trials

Comparison of Continuous Intravenous Lidocaine Infusion Versus ESP Block for Rib Fracture Analgesia

Rib Fract ESP
Start date: March 2024
Phase: Phase 2
Study type: Interventional

Recently in 2016, a new interfascial plane nerve block was developed for thoracic analgesia known as the erector spinae plane block (ESPB). Since its development for thoracic neuropathic pain, the ESPB has been shown to be effective in pain control in multiple procedures including thoracotomies. However, there have been a few published case reports of using ESPB for analgesia in rib fracture management and only one retrospective study which demonstrated improved NRS pain scores and increased incentive spirometry volumes (ICV) post-ESPB compared to pre-ESPB values. The goal of this study is to compare the effectiveness of ESPB as an alternative method to the current standard of care at Stanford Health Care (SHC) for pain management in traumatic rib fractures. At the investigator's institution, the current standard of care is intravenous (IV) and enteral multimodal analgesia that consists primarily of opioids and a continuous IV lidocaine infusion. Although IV lidocaine has shown some benefit in improving post-surgical pain scores, evidence for its use in MRF is lacking. The purpose of this study is to perform a randomized clinical trial comparing outcomes in pain control and incentive spirometry volumes between continuous ESPB catheters and IV lidocaine infusions in adult patients with acute traumatic rib fractures. The investigators want to determine if ESPB can provide improved pain control in patients admitted for traumatic rib fractures compared to IV Lidocaine. The aim is to evaluate the clinical effectiveness of ESPB on OME consumption, pain scores, incentive spirometry volumes, cough strength, respiratory complications, inflammatory biomarkers and hospital LOS. Findings from this study can help improve analgesia, quality of care, and patient satisfaction at Stanford Healthcare and for other acute pain and trauma surgery providers. The aim of this study involves pain management for patients with acute traumatic rib fractures and therefore must involve human subjects.

NCT ID: NCT04687592 Not yet recruiting - Clinical trials for Femoral Neck Fractures

Vertical Femoral Neck Fractures in Young Adult Patients

Start date: June 2021
Phase:
Study type: Observational

Does the current techniques of internal fixation of vertical neck fracture in young adult patients give a satisfactory radiological and functional outcome at one year follow up?

NCT ID: NCT04681846 Not yet recruiting - Fracture Non Union Clinical Trials

Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults

Start date: March 2021
Phase:
Study type: Observational

Assessment of the efficacy of the multistage technique in the eradication of infection and achieving the union of traumatic infected femoral un-united shaft fractures in adult patients for one year follow up.

NCT ID: NCT04648488 Not yet recruiting - Elbow Fracture Clinical Trials

Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The purpose with the study is to evalute if early mobilsation after surgery in patients vid elbow frakture-dislocation may lead to better armfunction and reduce common complications as stiffnes in the elbow. After surgery patients will be randomised to either early mobilisation (exercise treatment 3 Days after surgery) or ordinary treatment (plaster and exercise treatment 3 weeks after surgery).

NCT ID: NCT04642209 Not yet recruiting - Anesthesia Clinical Trials

Aggregometry in Elderlies With Hip Fracture and Receiving Clopidogrel

Start date: December 1, 2020
Phase:
Study type: Observational

In elderly patients, hip fracture should be surgically treated within 48 hours from admission, since its deferral worsens the mortality. However, sometimes patients are affected by cardiovascular or cerebral comorbidities, deeming necessary the use of antiplatelets and/or anticoagulant therapies. Clopidogrel is a second-generation thienopyridine antiplatelet drug which exerts its effect by the inhibition of the platelet's purinergic receptor P2Y12 preventing adenosine diphosphate (ADP) from stimulating it. Guidelines recommend to withhold clopidogrel for 5 days before the possibility to perform neuraxial anesthesia, which is frequently the optimal perioperative management of a fragile patient. It should be mentioned however that around 30% of patients are resistant to clopidogrel and they show a normal platelet reactivity despite the antiplatelet therapy. Therefore, in principle, these patients do not require to defer surgery. We have therefore hypothesized that some patients taking clopidogrel might anticipate surgery before 5 days and within 48 hours, following a protocol based on the assessment of coagulation and platelet aggregation through thromboelastography (TEG) in combination with an ADP Platelet Mapping assay kit. After hospital admission for femur fracture, eligible patients would be evaluated by the anesthesiologist and the orthopedic physicians for anesthesia and surgery. Immediately a sample of blood should be collected for TEG with ADP Platelet Mapping test. If both MA-ADP and platelets aggregation (%) will be within normal values, the patient could be considered as candidate for immediate surgery (within 48 hours) with neuraxial anesthesia and ultrasound-guided antalgic femoral nerve block. If MA-ADP and/or platelets aggregation (%) are lower, risk for mortality should be assessed. If the patient would be considered at high risk for mortality, he/she would undergo to general anesthesia and peripheral antalgic block to not postpone surgery. Otherwise, surgery would be postponed until the normalization of both MA-ADP and platelet aggregation.

NCT ID: NCT04618549 Not yet recruiting - Hip Fractures Clinical Trials

Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

In general, hip fractures in the elderly are associated with a high one year-mortality up to 36 %. Apart from choosing the proper treatment, optimizing the surgical technique itself offers options to improve the outcome. Early mobilization after hip hemi¬arthroplasty correlates with improved ambulation, reduced need for assisted transfers, and less use of extended care facilities after hospital discharge. Nowadays, in order to reduce soft tissue damage and gain quicker postoperative recovery and faster rehabilitation, various MIS techniques have been proposed. Two of these techniques are the mini posterior approach and the mini direct anterior approach. The direct anterior approach was developed as a true internervous and intermuscular surgical approach with proposed benefits of faster recovery, quicker return to function, and less pain. In theory, the direct anterior approach should cause less tissue damage than mini posterior approach, as it is performed through a plane between neurlogical tissue and intermuscular plane without muscle transection. The aim of this study is to evaluate the clinical and radiological outcomes of the direct anterior approach for bipolar head endoprosthetic hemiarthroplasty in patients with displaced femoral neck fractures in comparison with the mini posterior approach and the traditional lateral approach, for the treatment of the same fractures. The investigators hypothesized that patients undergoing the direct anterior approach would have better clinical and radiological results in comparison with the mini posterior and lateral approach.

NCT ID: NCT04605341 Not yet recruiting - Metacarpal Fracture Clinical Trials

Miniplate Versus k Wires in Management of Metacarpal Fracture

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

To compare between buried k wires and miniplate in management of metacarpal fracture.

NCT ID: NCT04572022 Not yet recruiting - Trauma Clinical Trials

Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice

Start date: December 2023
Phase: N/A
Study type: Interventional

Proximal humerus fracture patient's upper limb complete function restoration mainly depends on patient rehabilitation exercises. One time teaching in clinic is usually not sufficient for patients to learn their rehabilitation exercises. This leads to delayed patient recovery and dis-satisfaction to treatment provided by health care providers. Our aim is that mobile health technology might facilitate patient to easily access health related teaching information other than routine care to support patient in their self-health care management thus leading to proximal humerus fracture patient treatment outcome improvement. Hypothesis: Mobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales. Objectives: Primary objective: 1. To improve adult proximal humerus fracture patient's clinical and functional outcomes using validated outcome scoring scales resulting in timely recovery with the help of patient self-health care capacity using mobile health app. 2. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care. Secondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application. Methods: Study design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial. Total 60 subjects required with 30 in each arm in 24-month duration. Study procedures: 1. Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents/surgeon. 2. Patients of 18 to 58 years of age with trauma associated proximal humerus fractures, who or their attendants are willing to participate. Patients who requires special care, patient not willing to exercise at home without physiotherapist support or participate in survey questionnaire and patients who does not have facility of classic blue tooth connectivity will be excluded. 3. Written informed consent will be administered the study subjects as per GCP guideline. 4. Each eligible patient will be randomized into intervention or control group. 1. Intervention group: Classic Blue tooth technology will be utilized for interoperable solution of teaching video information sharing from doctor to patient. The end users will be enrolled trauma associated proximal humerus fracture patients whether treated surgically or conservatively. 2. Control group: Routine care will be provided to control group and as per routine. 5. The patient will be followed at 6 weeks, 3 and 6 months. Data will be collected on Case report form by assigned person. Clinical and functional outcomes will be assessed by assigned person using Quick DASH and Oxford shoulder score. 6. Researchers will be trained on data collection form prior to data collection. In case of lost to follow-up, patients will be contacted by telephone. 7. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes. 8. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes. 9. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious/Adverse event (SAE/AE), any patient who experience SAE/AE, will receive good clinical care at earliest and all relevant reporting bodies will be notified. 10. Data management will be carried out at the Department of Surgery. Subject data confidentiality will be maintained. After study completion, data will be archived and retained for maximum years. Statistical Consideration: Quantitative variables will be expressed as mean ± standard deviation and qualitative variables as frequencies (percentages). The efficacy on the basis of clinical and functional outcome and the AEs/SAEs will be assessed by intention to treat analysis. For group comparisons of clinical and functional categorical outcomes, chi-square test or Fisher Exact will be applied. p-values of less than 0.05 will be considered as statistically significant with a confidence interval of 95%. Patient and doctor satisfaction scores will be analyzed using regression analysis. For Assessment of outcomes, repeated measure ANOVA and generalized estimating equation will be used. Multiple regression will be used to assess the association between multiple covariates.

NCT ID: NCT04564326 Not yet recruiting - Hip Fractures Clinical Trials

PENG Block Versus Fascia Iliaca Block for Pre- and Post-Operative Analgesia in Elderly Patients With Hip Fracture

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Clinical controled trial to compare between pericapsular Nerve Group Block and Fascia Iliaca Block to find the best way to provide analgesia for elderly patients with hip fracture in the pre- and post-operative periods.

NCT ID: NCT04541758 Not yet recruiting - Clinical trials for Surgery--Complications

Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.