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Rotator Cuff Injuries clinical trials

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NCT ID: NCT06215417 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial

HDA v Regen
Start date: March 2024
Phase: Phase 4
Study type: Interventional

Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.

NCT ID: NCT06095050 Not yet recruiting - Shoulder Pain Clinical Trials

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

ELECTRC
Start date: December 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) > 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

NCT ID: NCT06071884 Not yet recruiting - Pain Clinical Trials

Bridge Device for Surgical Pain for Rotator Cuff Surgery

Start date: July 31, 2024
Phase: N/A
Study type: Interventional

The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation.

NCT ID: NCT06043791 Not yet recruiting - Clinical trials for Labral Tear, Glenoid

Applicability of 3T Shoulder MRI in Detection of Labral Pathology

Start date: April 2024
Phase: N/A
Study type: Interventional

The purpose of this observational study is to compare image quality between 3 Tesla magnet (3T) non-contrast MRI to the current standard of MR arthrogram (1.5T magnet) in detecting shoulder labral and cartilage pathology. An orthopedic surgeon on the research team will screen for patients with high probability of labral and/or cartilaginous pathology and the need for advanced imaging. The orthopedic surgeon's inclusion of patients will be based on a thorough clinical exam and obtained history. Patients included in the study will be imaged using both protocols - the current standard of MR arthrogram with a 1.5T magnet and non-contrast imaging with a 3T magnet. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.

NCT ID: NCT06032416 Not yet recruiting - Rotator Cuff Tears Clinical Trials

DenCT Shoulder Bone Quality Evaluation

Start date: April 2024
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.

NCT ID: NCT06023914 Not yet recruiting - Clinical trials for Subacromial Impingement Syndrome

Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength.

Start date: September 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Introduction: Shoulder disorders are a common musculoskeletal problem causing pain and functional loss in different populations. Tendinopathies are a group of pathologies commonly diagnosed in patients with shoulder pain. Weakness of the rotator cuff musculature has already been documented in other studies, evidence in the literature suggests that patients with tendinopathies demonstrate decreased muscle activation, this is caused by pain, changes in nervous system processing and apparently also by structural processes that occur in the tendon .Treatment often involves resistance, isometric exercises aimed at altering pain and restoring function. Some studies have been investigating the use of ENMS (neuromuscular electrical stimulation) in patients undergoing surgical procedures on the shoulder, other studies have also investigated its use in tendinopathies of the lower limbs, as an effective way to decrease inhibition. Objective: The main objective of this study will be to analyze the muscle strength of internal and external rotation of symptomatic shoulders compared to asymptomatic ones when exposed to neuromuscular electrostimulation, associating muscle strength with joint function. Methodology: This will be a cross-sectional study. An expected total of 48 subjects will be divided into two groups, n=24 with tendinopathy of the rotator cuff, confirmed by clinical diagnosis and nuclear magnetic resonance imaging, the other group being healthy individuals, with no history of shoulder pain. These individuals will be evaluated by a first evaluator who will perform the eligibility of the subjects and collect the initial information, the second evaluator will perform the isometric strength evaluation with a manual dynamometer. Two batteries of tests will be performed in both groups, a conventional assessment of isometric strength and the other subject will be submitted to neuromuscular electrostimulation. These strength values in Kgf were normalized for each individual, being divided by the body mass index (BMI) and multiplied by 100, as already performed in previous studies. Expected results: The initial hypothesis is that patients who present with the studied condition when submitted to the strength test with muscular electrostimulation will demonstrate greater isometric strength than when they were tested without the device.

NCT ID: NCT06016439 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

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

Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence. This is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group. The hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.

NCT ID: NCT06002009 Not yet recruiting - Orthopedic Disorder Clinical Trials

SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function

SSCuFF
Start date: September 2023
Phase:
Study type: Observational

The primary objective of the study is to determine in adult patients with a rotator cuff tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular nerve. The secondary objectives are 1. To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired. 2. To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged. 3. To determine factors that are protective against SSN injury. 4. Can the patient data gathered be used to optimise operative procedures.

NCT ID: NCT05913050 Not yet recruiting - Clinical trials for Rotator Cuff Injuries

Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

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

The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.

NCT ID: NCT05909930 Not yet recruiting - Clinical trials for Rotator Cuff Injuries

Effectiveness of TheRApeutic ExercIse aNd EDucation on Patients With Massive Rotator Cuff Tears

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

The aim of this multicenter non-controlled study will be to evaluate the effectiveness of a physical therapy treatment based on resistance exercise and education for patients with massive rotator cuff tears.