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NCT ID: NCT06289686 Recruiting - Surgery Clinical Trials

MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Start date: March 2024
Phase: Phase 4
Study type: Interventional

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.

NCT ID: NCT06289309 Recruiting - Surgery Clinical Trials

NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury. The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique. A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each). The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy.

NCT ID: NCT06287151 Recruiting - Surgery Clinical Trials

Regional Anesthesia EMG Study

Start date: August 9, 2023
Phase: N/A
Study type: Interventional

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies.

NCT ID: NCT06279377 Recruiting - Surgery Clinical Trials

Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery

Start date: May 5, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effects of the stabilization exercise program applied after cervical laminoplasty surgery compared to standard exercise on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level). The main question[s] it aims to answer are: - Does the exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)? - Does the stabilization exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)? Patients will start their first exercise session on the day they will be discharged from the hospital. Patients in both exercise groups will be provided with cervical normal joint movement (ROM), posture and patient education on the day of discharge. They will be asked to do posture exercises and neck exercises under the guidance of a physiotherapist. Patients in the stabilization exercise group (experiment) will undergo stabilization exercises under the supervision of a physiotherapist, in addition to the practices in the standard exercise group. Both groups will do a warm-up program before exercise and a cool-down program afterwards. Patients will be asked to do the exercises face to face with a physiotherapist 3 days a week. The first evaluations will be made on the day they come to the outpatient clinic for examination before surgery. Post-surgical evaluations will be made routinely after the exercise program is completed, when they are called by the physician for a check-up (6th week). Researchers will compare the standard exercise group with the stabilization exercise group to see if pain, dysfunction, normal joint movement, proprioception, balance, muscular endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level) are different.

NCT ID: NCT06277180 Recruiting - Surgery Clinical Trials

68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.

NCT ID: NCT06260618 Recruiting - Surgery Clinical Trials

Effect of Chitodex Gel in Tympanoplasty Surgery

Start date: November 20, 2021
Phase: N/A
Study type: Interventional

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP).

NCT ID: NCT06243848 Recruiting - Surgery Clinical Trials

Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel Syndrome

Start date: January 25, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.

NCT ID: NCT06213454 Recruiting - Surgery Clinical Trials

Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery

Start date: March 26, 2024
Phase: Phase 4
Study type: Interventional

This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.

NCT ID: NCT06205875 Recruiting - Surgery Clinical Trials

High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.

Start date: February 21, 2024
Phase: N/A
Study type: Interventional

This study aims to compare the efficacy and quality of pain relief provided by the high-dose serratus anterior plane (SAP) block with the standard SAP block in preventing and treating acute postoperative pain after total endoscopic aortic or mitral valve surgery.

NCT ID: NCT06189287 Recruiting - Surgery Clinical Trials

Ethics and Research in Anaesthesia

Anesth_ethic
Start date: March 1, 2023
Phase:
Study type: Observational

Under the impetus of governing bodies, learned societies, hospital management, CPPs, etc., clinical research has developed and structured considerably, in order to provide the medical community and patients with the most appropriate care, and to formulate recommendations. In anesthesia, clinical research evaluates drugs, medical devices or care pathways. However, the general public's perception of this research in our specialty remains confidential. Several studies carried out in oncology have shown limited interest in research on the part of the general public and patients, and more often than not a lack of awareness of ethical laws and the role of french ethics committee (CPP). By means of an anonymous questionnaire handed out at the anesthesia consultation, the investigators would like to assess patients' level of knowledge of clinical research in anesthesia, and find out how they feel about the possibility of being included in a trial.