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Showing 1-13 of 13 trials
NCT07464977
Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle implies a medialization and distalization of the center of rotation (COR). Deficiencies in internal and external rotation constitute frequently encountered functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs demonstrated increased external rotation through an alteration of the deltoid's lever arm. The aim of the study is to investigate the impact of lateralization on functional outcome and deltoid EMG activity in comparison to a standard implantation technique.
NCT06505135
Treatment of rotator cuff tears with micro-fragmented adipose tissue is a minimal-invasive procedure with the potential to shorten and ease recovery, accelerate return to daily activity and work of thus with a potential capacity to improve the functional result compared to conventional surgery alone. The study will provide evidence whether the addition of micro-fragmented adipose tissue therapy can augment conventional rotator cuff tear treatment. The study will also reveal whether this treatment can be feasible for standard care of patients with rotator cuff tear as it will be simple to standardize. Moreover, besides providing a novel treatment for patients with rotator cuff tears, the project will based on data from muscle biopsies and scanning modalities, generate new knowledge, preparing for precision regenerative medicine in shoulder disease.
NCT07255534
1. Importance of Rehabilitation After Rotator Cuff Repair Rotator cuff tears are among the most common shoulder conditions in Korea. They can occur naturally with aging or result from trauma or overuse. When conservative treatments like medication or injections fail to relieve pain and restore function, rotator cuff repair surgery is necessary. Postoperative rehabilitation exercises are crucial for recovering shoulder function, reducing pain, and returning to daily activities. Many studies have emphasized the importance of staged rehabilitation and patient education after surgery, showing that active patient participation directly affects recovery. However, some patients rely on unverified internet sources (such as YouTube or online forums) or face limitations such as time, geographical constraints, or cost even when receiving face-to-face therapy. 2. Advantages of Digital Therapeutics Digital therapeutic devices have emerged as a promising solution to these challenges. These smartphone applications deliver exercise and educational content tailored to postoperative rehabilitation, aiming to improve the disease state. They offer anytime, anywhere access without time or location restrictions and provide evidence-based, systematic, and personalized rehabilitation programs. Comprehensive educational materials enhance patient understanding and promote self-management skills, potentially increasing rehabilitation adherence. 3. Recent Research Findings Digital rehabilitation programs for patients after rotator cuff repair have demonstrated effectiveness. Programs that provide real-time exercise feedback using mobile apps and sensors have shown similar or superior outcomes compared to traditional physical therapy. Augmented reality (AR)-based rehab systems are more effective in improving shoulder function than conventional methods, and digital apps offering customized exercise videos significantly enhance physical function and confidence. Notably, patients using digital rehabilitation programs for 1 to 6 months exhibited improved adherence to therapeutic exercises, facilitating consistent home-based rehabilitation. 4. Purpose of This Clinical Trial While previous studies have confirmed the efficacy and safety of digital therapeutic devices after rotator cuff surgery, most are limited to generic exercise programs. This clinical trial aims to evaluate the effectiveness and safety of a clinical trial digital therapeutic device not yet approved domestically, providing disease-specific exercise programs.
NCT03547947
This is a post-marketing surveillance on Medacta Shoulder System
NCT01405781
The objective of this study is twofold: First, to determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function, Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically examine and perform a radiographic analysis of patients at a minimum of 6 months after reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator cuff repair.
NCT02588027
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
NCT03111147
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
NCT06105398
Determining the factors affecting hand function after upper limb injuries is very important for maintaining independence in daily living activities. The aim of this study is to determine the relationship between core stability and hand function in patients undergoing rotator cuff surgery and to compare the results with healthy patients of a similar age. The aim of this study is to determine the relationship between core stability and hand function in patients undergoing artroscopic cuff surgery.
NCT03425500
To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.
NCT01778777
The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.
NCT04645329
Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. However, there are no studies that determine the most appropriate period of immobilization. In fact, patients undergoing this type of surgery begin rehabilitation exercises within 24 hours of surgery without experiencing increased pain or requiring specific analgesic treatment. There is a demand in the elderly to limit immobilization time as much as possible, as some live alone and need to be self-sufficient and others have dependents. It would be good to know if it is really necessary to make an immobilization in these patients undergoing this type of surgery.
NCT02512536
Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen both in primary and secondary care. It is a painful condition, with significant disability. Specialist shoulder replacements have found acceptance within the trust, nationally and internationally although there are high complication rates. There is however a significant cost difference (fifty fold) between a reverse total shoulder replacement and a botox injection, and to date there have been no randomised control trials, or any registered, comparing the use of a botox injection for pain relief in cuff arthropathy versus no treatment. If there is a significant clinical difference in the pain outcomes between the two, this could result in significant savings to the NHS and the taxpayer as a whole. If high levels of pain relief could be predictably obtained using Botulinum A toxin injections then potentially patients could avoid the need for surgery.
NCT02052466
The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical scapular notching that develops following reverse total shoulder arthroplasty (TSA).