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Rotator Cuff Tears clinical trials

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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: NCT06010264 Completed - Rotator Cuff Tears Clinical Trials

THE EFFECTS OF EARLY PERIOD KINESIOTAPE

Start date: July 6, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to the effects of kinesio tape application on pain, edema, range of motion and functionality . The main questions it aims to answer are: - Does kinesiotape application reduce pain and edema and improve quality of life in the early period in individuals undergoing arthroscopic rotator cuff repair? - Does kinesiotape application provide early restoration of functional activity level in individuals undergoing arthroscopic rotator cuff repair? Participants will receive kinesiotaping in addition to traditional physiotherapy programs. If there is a comparison group: Researchers will compare kinesiotape group, shamtape group and control group to see if kinesiotaping.

NCT ID: NCT05997381 Enrolling by invitation - Rotator Cuff Tears Clinical Trials

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

REinForce
Start date: January 5, 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.

NCT ID: NCT05988541 Recruiting - Rotator Cuff Tears Clinical Trials

Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

Start date: October 3, 2023
Phase: N/A
Study type: Interventional

The study gives an overview of surgically treated rotator cuff injury patients in Tartu University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair. First stage of the study describes the study population, etiology of the injury (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are in line with the preoperative imaging studies or not. Second stage of the study focuses on atraumatic tendon tears assessing structural integrity of the tendons 5 years after repair using ultrasound imaging. The main question is - does the findings correlate with clinical outcomes and patient satisfaction. Participants of the second phase of the study will be asked for an appointment to have their shoulders examined with ultrasonography and clinical outcomes are measured using the American Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and The Constant-Murley score (CMS).

NCT ID: NCT05959733 Recruiting - Rotator Cuff Tears Clinical Trials

Maximal Repair Versus Bridging Reconstruction With BioBrace®

Start date: December 7, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.

NCT ID: NCT05946343 Recruiting - Shoulder Pain Clinical Trials

Rotator Cuff Tear Severity and Scapular and Rotator Cuff Muscle Activation Patterns

Start date: July 15, 2023
Phase:
Study type: Observational

Rotator cuff tears are common musculoskeletal injuries that can lead to altered scapular and rotator cuff muscle activation patterns and reduced function. This study aims to investigate the relationship between rotator cuff tear severity and scapular and rotator cuff muscle activation patterns. The primary objective of this study is to determine whether a relationship exists between the severity of rotator cuff tears and the activation patterns of scapular and rotator cuff muscles. Secondary objectives include: 1. Identifying differences in muscle activation patterns between varying tear sizes. 2. Evaluating the potential of these activation patterns as an indicator for the severity of rotator cuff tears. 3. Assessing the influence of muscle activation patterns on the functional capacity of the affected shoulder.

NCT ID: NCT05933382 Completed - Rotator Cuff Tears Clinical Trials

Investigation of the Effects of Mulligan Mobilization and Corticosteroid Injection in Rotator Cuff Lesions

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

Chronic shoulder pain, predominantly caused by rotator cuff disorders represents one of the most frequently encountered musculoskeletal issues within the community. Rotator cuff tears are a crucial pathophysiological contributor to shoulder pain. Individuals afflicted with this condition frequently report nocturnal intensification of pain and movement-specific aggravation, especially during overhead activities. The condition is frequently correlated with functional impairment, with many patients noting a sensation of weakness. Conservative treatment of the rotator cuff tear consists of a wide range of procedures such as exercise therapy; and/or local anesthetic, ice/heat therapy, electrotherapy, various types of manual therapy and joint mobilization procedures. Corticosteroid injection approach is an alternative method to these applications The subacromial corticosteroid injection is an intervention technique that has been utilized for short-term relief over numerous years.Given the restricted self-repair capabilities of tendons the consideration of novel biological treatment strategies for tendinopathies has gained prominence in recent times. Nonetheless, there remains a lack of sufficient scientific evidence to substantiate their efficacy.Mulligan mobilization techniques are manual therapy techniques that aim to increase normal joint movement and reduce pain levels by correcting the biomechanical structure of joint surfaces to provide a pain-free range of motion. A review of the literature reveals no studies comparing the Mulligan mobilization technique and corticosteroid injections in rotator cuff tears. The aim of our study is to examine the effects of the Mulligan mobilization technique and corticosteroid injections on pain, range of motion, functionality and proprioception in individuals with rotator cuff tears.

NCT ID: NCT05925881 Recruiting - Rotator Cuff Tears Clinical Trials

Lower Trapezius Transfer vs Bridging Reconstruction

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears. The main questions it aims to answer are: - comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance - compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.

NCT ID: NCT05924360 Completed - Rotator Cuff Tears Clinical Trials

Impact of Mulligan and Maitland Techniques on Rotator Cuff Lesions

Start date: June 23, 2023
Phase: N/A
Study type: Interventional

The shoulder joint in the human body has a broader range of motion and opening compared to other joints, resulting in a multitude of potential problems. The rotator cuff lesion is one such issue. The rotator cuff is found in the subacromial space of the shoulder and results from the compression of the subacromial bursa and the long head of the M.biceps muscle between the humerus and the coracoacromial arch. Upon reviewing the literature, therapeutic exercise and electrotherapy modalities are the most preferred and studied areas. Alongside these, we also observe the usage of Mulligan and Maitland techniques for the treatment of rotator cuff lesions. The Mulligan technique was developed by Brian Mulligan in 1980, who lent his name to it. Also known as mobilization with movement, this technique is often applied to the body's distal joints. The Maitland mobilization technique is used to treat the relevant joint with specific methods, particularly focusing on pain and stiffness in the joint. The technique's application is graded from 1 to 4. Grade 1 is a small oscillation created without loading throughout the joint movement. Grade 2 is performed with a slightly more oscillation from the beginning of the movement. Grades 1 and 2 aim to restrict the pain stimulus going to the central nervous system by stimulating the mechanoreceptor in the joint, thereby reducing the sensation of pain. Grade 3 is applied at a larger amplitude until a limitation is felt from the middle of the joint movement. Lastly, grade 4 is applied to the limited small amplitude until tissue resistance is felt. Grades 3 and 4 are used to alleviate joint stiffness by applying shorter oscillation stimuli to a shorter tissue. The results of the use of Mulligan and Maitland techniques have been demonstrated in different studies in the literature. However, as far as we know, no study in the literature compares these two techniques in individuals with rotator cuff lesions. Based on this gap in the literature, the purpose of this study is to investigate the effects of the Mulligan technique and the Maitland method on pain, range of joint motion, functionality, joint position sense, and quality of life in individuals with a rotator cuff problem.

NCT ID: NCT05906004 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch

Start date: January 2024
Phase:
Study type: Observational [Patient Registry]

This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions. The medical device in this study is already on the market and is manufactured by Xiros Ltd. The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair. The study will collect data on patients who meet the entry criteria and have received the device. This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years. A minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).