View clinical trials related to Rotator Cuff Tears.
Filter by: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.
The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone. The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone. Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.
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.
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.
This is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available AEQUALIS FLEX REVIVE shoulder system in both the anatomic and reversed configurations. The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.
This randomized-controlled trial aims to investigate the efficacy of cross-education on function, pain, and range of motion, muscle strength and quality of life in patients who underwent arthroscopic rotator cuff repair.
This study is comparing total intravenous anesthesia with propofol with a regional nerve block against general anesthesia with a regional nerve block on the primary endpoint of time to meet discharge criteria.
Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged <40 years and in 54% of patients aged >60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery. Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed. The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.