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Rotator Cuff Injuries clinical trials

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NCT ID: NCT06139666 Enrolling by invitation - Postoperative Pain Clinical Trials

The Effect of Liposomal Bupivacaine Nerve Block (Exparel) in Rotator Cuff Surgery

Start date: July 11, 2019
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone. The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone. Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.

NCT ID: NCT05974423 Enrolling by invitation - Opioid Use Clinical Trials

Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair

Start date: December 16, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if patients age 15 to 30 years old being treated for shoulder labrum repair and SLAP lesions have significant differences in pain levels postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen compared to oxycodone. Participants will be randomly placed into either the control arm and receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the experimental arm of the study. receiving only a prescription for the non-narcotic medications. Every patient will receive a preoperative Exparel nerve block as is the standard of care for this procedure. Both groups will fill out a pain journal for 14 days following surgery and complete a pill count at the first postoperative visit to validate the amount of pain medication documented in the pain journal.

NCT ID: NCT05779033 Enrolling by invitation - Clinical trials for Shoulder Impingement Syndrome

Ultrasound Versus Kinesiotaping in Shoulder Impingement Syndrome

US-SIS-KT
Start date: April 9, 2023
Phase: N/A
Study type: Interventional

studying the effect of ultrasound and kinesiotaping in shoulder impingement syndrome in reliefing pain and increase range of motion in subjects with shoulder impingement syndrome .

NCT ID: NCT05584553 Enrolling by invitation - Clinical trials for Biceps Tendon Disorder

PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder

Start date: December 2, 2022
Phase:
Study type: Observational

The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm and the JuggerLoc Soft Tissue Systems when used for soft tissue to bone fixation in the shoulder. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the shoulder. The secondary objective is the assessment of safety and clinical benefits. Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to device, instrumentation and/or procedure will be specified. Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs) at the longest follow-up after surgery (minimum one year).

NCT ID: NCT05566470 Enrolling by invitation - Rotator Cuff Tears Clinical Trials

Central Neuromuscular Dysfunction, Functionality, Psychological Status and Rotator Cuff Surgery

Start date: August 17, 2022
Phase:
Study type: Observational [Patient Registry]

Considering the fact that The problems experienced by the patients are not only physiological but also psychological and social. Unfortunately, there is no sufficient study focus on all these concepts. Generally, studies focus on only physiological dimensions such as functional level, muscle strength and pain. The aim of this study, in addition to assessment methods commonly used for functional level, muscle strength and pain, is to evaluate central neuromuscular function on individuals who have undergone rotator cuff tear surgery with transcranial magnetic stimulation. Furthermore, psychological resilience, which is considered as a positive psychological trait, will also be evaluated. Until now, only one study has evaluated the role of psychological resilience in the postoperative process of rotator cuff surgery. This study has shown that the correlation between functionality and psychological resilience. As a result of our study, the influence of resiliency on postoperative outcomes following rotator cuff surgery will be determined and central neuromuscular function, shoulder functional level, and psychological resilience changes will be revealed in physiological and psychological concepts. Furthermore, this study may show that psychological resilience has a potential role on predicting functional level and pain. It is planned that the results obtained will guide the postoperative rehabilitation of rotator cuff surgery for further studies on multidimensional perspectives.

NCT ID: NCT05500066 Enrolling by invitation - Clinical trials for Rheumatoid Arthritis

AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

REVIVE
Start date: January 11, 2023
Phase:
Study type: Observational

This is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available AEQUALIS FLEX REVIVE shoulder system in both the anatomic and reversed configurations. The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.

NCT ID: NCT05400798 Enrolling by invitation - Clinical trials for Partial Thickness Rotator Cuff Tear

A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This is a longitudinal follow-up study of the RC-002 study, in which up to 246 subjects assigned to two randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio and will be followed up for 6 months. The goal of the RC-004 study is to enroll all patients that were enrolled and treated in RC-002 and follow for 3 years.

NCT ID: NCT05266339 Enrolling by invitation - Surgery Clinical Trials

Cross-education in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial

Start date: May 9, 2022
Phase: N/A
Study type: Interventional

This randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair.

NCT ID: NCT04793022 Enrolling by invitation - Anesthesia Clinical Trials

Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries

TIVA
Start date: February 2, 2021
Phase: Phase 4
Study type: Interventional

This study is comparing total intravenous anesthesia with propofol with a regional nerve block against general anesthesia with a regional nerve block on the primary endpoint of time to meet discharge criteria.

NCT ID: NCT04673344 Enrolling by invitation - Rotator Cuff Tears Clinical Trials

Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

Start date: December 30, 2020
Phase: N/A
Study type: Interventional

Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged <40 years and in 54% of patients aged >60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery. Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed. The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.