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NCT04944836
Shoulder tendon tears are a common cause of shoulder pain and disability and after surgery the repaired tendon often does not heal. In this pilot study, men with low sex hormone levels will be randomly assigned to receive sex hormone therapy or placebo pills while healing from tendon repair surgery in their shoulder. Sex hormone therapy increases sex hormone levels, and the investigators will test whether these increased sex hormone levels show promise in improving tendon healing and patient shoulder function and pain.
NCT06318403
Rotator cuff tears in the shoulder are common causes of pain and disability, often fail to heal with surgery, and tears, worse outcomes after surgery, and failure of healing are associated with estradiol deficiency. In this study, post-menopausal women will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, muscle volumes, and function when given with rotator cuff repair.
NCT05397652
Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized controlled study is to evaluate the effect of intravenously administered tranexamic acid (TXA) on intraoperative visual clarity, perioperative blood loss, procedure duration, and early postoperative outcomes in patients undergoing shoulder arthroscopy in the beach chair position, an area for which limited data are currently available in the literature. In both the experimental and control groups, hemoglobin levels are measured in the irrigation fluid and in patients' blood samples obtained before and after surgery. Additional outcomes include intraoperative visual clarity, duration of the procedure, postoperative shoulder swelling, postoperative pain intensity, and analgesic consumption.This study applies established scientific methods to determine whether there is a justified basis for the introduction of TXA into routine clinical practice for shoulder arthroscopy.
NCT05906004
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 3 years. A minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
NCT07192302
A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial)
NCT06735170
The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.
NCT06918041
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument SN). The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.
NCT06741527
The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).
NCT06353893
The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are: * How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS? * What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant? Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.
NCT01193647
This study will begin to evaluate the heritability of rotator cuff disease, and begin creation of a powerful resource for future genetic studies of rotator cuff disease.
NCT04340752
Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.
NCT05780229
The purpose of this study is: 1) to identify relevant treatment outcomes for people with massive rotator cuff tears of the shoulder joint, according to the experience of the affected people, to facilitate treatment shared decision-making during the specialist consultation in Spain; 2) to compare the effectiveness of conservative treatment, arthroscopic decompressive surgery and reverse prosthesis, in terms of patient's relevant outcomes and health-related quality of life.
NCT05566470
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.
NCT06733480
Participants are being invited to take part in this research study because you will be undergoing total shoulder replacement or rotator cuff repair and will be participating in physical therapy rehabilitation following the procedure. The purpose of this research is to investigate the effectiveness of Band Connect, a connected health platform, in enhancing compliance with home exercise programs among patients undergoing physical therapy. This study aims to evaluate the implications of increased compliance on improving patient engagement and increasing satisfaction for both patients and clinicians. Additionally, the study will analyze the economic implications of implementing Band Connect's hybrid care model on driving increased revenue per patient.
NCT04325789
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.
NCT06422390
Regenerative medicine, specifically orthobiologics is a hot topic in the community and in Sports Medicine. Riding the hype curve of a new treatment can be great when offering new procedures to patients. However, as the excitement regarding potential benefits of orthobiologics grows, it is valuable to grow the body of literature on their safety and efficacy in various musculoskeletal conditions. Furthering the body of data regarding which musculoskeletal conditions may benefit most from these treatments and which may not can help guide physicians on when to incorporate orthobiologics into clinical practice. More robust data can help physicians guide patients and patient expectations when discussing treatment options. Platelet rich plasma (PRP) in musculoskeletal medicine is most commonly used to treat tendinopathies and degenerative joint disease. The American Medical Society for Sports Medicine released a position statement in November of 2021 summarizing meta-analysis and systemic review data evaluating efficacy and major adverse events of PRP for tendinopathy and osteoarthritis1. At this time, the most robust data exists for lateral epicondylopathy as multiple randomized controlled trials demonstrate positive response to PRP. Gluteus medius tendinopathy and plantar fasciaopathy similarly have positive data. In Achilles tendinopathy, well designed RCTs have shown no difference between PRP and saline injections. These data should help guide physicians in responsible use and patient counseling. Data from Hurley et al. suggest PRP may augment rotator cuff repair with improved rates of healing and reduced overall pain. However, there are limited high quality studies on the efficacy of PRP alone in partial rotator cuff tear. Partial rotator cuff tear is a common musculoskeletal complaint that can be treated with conservative measures such as physical therapy and corticosteroid injection. It can also be treated with surgical intervention if those modalities provide incomplete or inadequate pain relief and functional restoration. This study aims to evaluate if PRP is an efficacious treatment modality for partial rotator cuff tear.
NCT06625723
Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.
NCT04552925
There are very few studies in the literature about conservative treatment of massive rotator cuff (RC) tears. Whether the treatment of massive RC tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. The aim of conservative treatment is to make the patient functionally independent and to reduce pain. In recent years, there are different opinions in the literature about the effectiveness of conservative treatment of massive RC tears. However, in recent biomechanical studies, it has been reported that the RC and the deltoid, which remain intact in massive RC tears, can function well together. The hypothesis of this study is that the deltoid-focused physiotherapy program, where strengthening exercises are performed with EMG biofeedback, will give more positive results in terms of range of motion (ROM), functional status, muscle strength, pain and patients satisfaction. aim of our study is to investigate the efficacy of electromyographic biofeedback (EMG-BF) device which was added to deltoid focused conservative treatment program in massive RC tears.
NCT06088667
Instrument-assisted soft tissue mobilization (IASTM) is a popular treatment method that can be used for myofascial restriction and fascial release. IASTM is used to reduce pain in the area where the pathology is located, increase range of motion (ROM), improve movement function and provide a mobilizing effect. When the literature was examined, no study was found examining the effectiveness of the IASTM technique, which is known to require less effort and stimulate healing compared to manual interventions, in the rehabilitation period after rotator cuff arthroscopic surgery. Therefore, our study aimed to examine the effects of instrument-assisted fascial mobilization given in addition to conventional rehabilitation on long-term pain, function, joint range of motion, fear of movement, and daily living activities in patients who have passed 4 weeks after rotator cuff arthroscopic surgery and are candidates for rehabilitation.
NCT04416932
The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. In addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. Our population would consist of patients that received total shoulder arthroplasty within the last 5 years.