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Rotator Cuff Tears clinical trials

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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: NCT05896475 Recruiting - Rotator Cuff Tears Clinical Trials

Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.

Start date: June 2, 2023
Phase:
Study type: Observational [Patient Registry]

In this prospective study, subjects older than 55 years with a degenerative asymptomatic rotator cuff tears will be followed for a period of 2 years. After testing, a symptom registration form will be filled in every 3 months. The test moment consists of pain measurements (pain pressure thresholds and conditioned pain modulation), biomechanical measurements (strength (including hand grip strength), range of motion, ultrasound (while measuring electromyographic activity) and shear wave elastography) and psychosocial measurements (psychosocial questionnaires).

NCT ID: NCT05879003 Recruiting - Rotator Cuff Tears Clinical Trials

Neuromuscular Electrical Stimulation on Humeral Adductors in Subjects With Rotator Cuff Tear: an Observational Study

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

The teres major and pectoralis major are adductors and may play a compensatory role for deficit in rotator cuff function. The investigators aim to (1) determine the effects of neuromuscular electrical stimulation (NMES) on the two adductors for the outcomes in symptomatic rotator cuff tear subjects, and (2) evaluate the immediate effect of NMES on the co-contraction of the adductors.Thirty symptomatic rotator cuff tear subjects will have NMES on the two adductors. The investigators will measure the acromiohumeral distance by ultrasonography and scapular kinematics during arm elevation with a three-dimensional motion tracking system. Co-contractions will be calculated by surface electromyography.

NCT ID: NCT05868148 Recruiting - Rotator Cuff Tears Clinical Trials

Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

SiD
Start date: October 20, 2023
Phase:
Study type: Observational

The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are: - What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and - What is the rate of surgical revisions needed over a 10 year period Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes.

NCT ID: NCT05855759 Recruiting - Rotator Cuff Tears Clinical Trials

Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears

MODA
Start date: October 15, 2023
Phase: N/A
Study type: Interventional

The use of biologic acellular matrices for the surgical augmentation of rotator cuff lesions has greatly expanded inrecent years. The study team patented a method for removing cells from human dermis (Acellular Dermal Matrix), maintaining unaltered biological and structural integrity. Acellular Dermal Matrix has been succesfully used for rotator cuff surgical repair augmentation beside in a limited number of patients. The aim of the project is to demonstrate the therapeutical efficacy of this strategy in patients affected by rotator cuff massive tears. Acellular Dermal Matrix will be also combined with autologous orthobiologics.

NCT ID: NCT05807854 Recruiting - Rotator Cuff Tears Clinical Trials

RSA vs RCR for Massive RCTs

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

Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

NCT ID: NCT05800184 Recruiting - Shoulder Pain Clinical Trials

Finnish Imaging of Shoulder Trauma

FIMAGE-T
Start date: April 5, 2023
Phase:
Study type: Observational

The FIMAGE-Trauma study is an extension of the FIMAGE study and aims to answer the question if rotator cuff tears found on shoulder imaging after a shoulder injury are caused by the index trauma or are rather incidental findings. Eligible participants of the FIMAGE study will be invited to a follow up visit in the case of a shoulder injury or a sudden onset of significant shoulder symptoms (within a 2-year time frame). These findings will then be compared to the baseline data collected in the FIMAGE study (including the comparison of pre-injury and post-injury MRI:s)

NCT ID: NCT05690776 Recruiting - Rotator Cuff Tears Clinical Trials

PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband

Start date: June 17, 2022
Phase:
Study type: Observational

The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the Quattro® X Suture Anchor with BroadBand™ Tape and Instruments when used in rotator cuff repair. The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient. The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Constant & Murley and EQ-5D-5L) at 1 year post-operative. The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.

NCT ID: NCT05624164 Recruiting - Rotator Cuff Tears Clinical Trials

Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing

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

The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are: - [whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.] - [whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.

NCT ID: NCT05603728 Recruiting - Clinical trials for Rheumatoid Arthritis

Exactech Shoulder Post Market Clinical Follow-up Study

Start date: January 2010
Phase:
Study type: Observational

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.