Rotator cuff tears in the shoulder are common, often cause pain and disability, often fail to heal with surgery, and both tears and failure of healing are associated with estradiol deficiency. In this study, women who have gone through menopause 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, and function when given with rotator cuff repair.

开始日期2025-04-01

申办/合作机构

University of Utah

NCT05906004 / Not yet recruitingN/A

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

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).

开始日期2024-11-01

申办/合作机构

Xiros Ltd.

NCT06635395 / Not yet recruitingN/AIIT

Translation and Cross-Cultural Adaptation of the Baltimore Orthopedic Subscapularis Score Into Turkish

The aim of this study is to adapt the Baltimore Orthopedic Subscapularis Score (BOSS) to Turkish society and to make its validity and reliability in Turkish. The BOSS was developed by Hameker et al to differentiate subscapularis tears from other rotator cuff muscle tears in patients with rotator cuff injuries. The BOSS has 5 questions. This study will be conducted with patients with rotator cuff injuries. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 25 participants will be included in the study. In order to evaluate the validity of the BOSS, the Western Ontario Rotator Cuff Disability Index (WORC), which can evaluate the functionality of the shoulder in patients with rotator cuff injury and has been validated in Turkish, and the SF-12 which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

开始日期2024-11-01

申办/合作机构

Medeniyet University

100 项与肩袖损伤相关的临床结果

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100 项与肩袖损伤相关的转化医学

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0 项与肩袖损伤相关的专利（医药）

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项与肩袖损伤相关的文献（医药）

2025-03-01·Medical Gas Research

Hyperbaric oxygen treatment promotes tendon–bone interface healing in a rabbit model of rotator cuff tears

Article

作者: Xiao, Meiling ; Li, Hongqiu ; Liang, A ; Yang, Feng ; Zhao, Zhonghai

Due to the high-intensity pressure that the shoulder cuff endures, it is prone to traumas and tears. The main critical function of the shoulder cuff muscles is to effectively facilitate shoulder movement and securely maintain the humeral head in the precise center of the joint cavity to prevent superior migration during abduction processes. Shoulder cuff injuries typically involve the muscle–tendon–bone interface, but existing repair techniques do not always guarantee complete and secure healing, leading to retears. Hyperbaric oxygen therapy, as an auxiliary treatment, can significantly promote the muscle–tendon–bone healing process. To explore the impact of hyperbaric oxygen therapy on the bone–tendon interface healing process in a rabbit model specifically designed for shoulder cuff tears, an experiment was conducted on New Zealand white rabbits by performing a full-thickness tear of the supraspinatus tendon in the left shoulder, followed by 2 hours per day of 100% oxygen treatment at 2 absolute atmospheres for 5 days. The results indicate that hyperbaric oxygen therapy significantly enhances vascularization at the interface between the shoulder cuff and tendon–bone, promotes collagen fiber regeneration in the tendon, improves the tensile strength of the tendon–bone complex, and does not have a significant effect on biomechanical stability. This suggests that hyperbaric oxygen therapy has a significant positive impact on the histological and biomechanical healing of shoulder cuff tears in rabbits, expediting the healing process of the tendon–bone interface.

2024-11-01·Arthroscopy: The Journal of Arthroscopic & Related Surgery

Atelocollagen Injection During Arthroscopic Rotator Cuff Repair for Small- to Medium-Sized Subacute or Chronic Rotator Cuff Tears Enhances Radiographic Tendon Integrity: A Propensity Score–Matched Comparative Study

Article

作者: Park, Jong Hun ; Kim, Hyun Gon ; Kim, Su Cheol ; Kim, Dae Yeung ; Lee, Sang Min ; Yoo, Jae Chul ; Kim, Jae Soo

PURPOSETo evaluate the clinical and structural outcomes of using injectable atelocollagen during arthroscopic rotator cuff repair (ARCR) for small- to medium-sized rotator cuff tears.METHODSThis retrospective study reviewed patients with small- to medium-sized full-thickness tears who underwent ARCR from 2016 to 2022 with a minimum 1-year follow-up. Propensity score (PS) matching was used to reduce bias. Tendon integrity was evaluated using magnetic resonance imaging (MRI) at postoperative 6 months. Clinical and structural outcomes were compared between the 2 groups.RESULTSAfter PS matching, this study included 181 pairs of patients comparing ARCR with atelocollagen injection and without atelocollagen injection. Range of motion, muscle strength, and functional outcomes were significantly improved in both the atelocollagen group and the control group. Forward elevation and external rotation were significantly worse in the atelocollagen group compared with the control group at 2, 6, and 12 months postoperatively and at the final follow-up. In total, 125 patients (69.1%) in the atelocollagen group and 130 patients (71.8%) in the control group exceeded the minimal clinically important difference in the American Shoulder and Elbow Surgeons score without a significant difference between the 2 groups (P = .509). The mean value of Sugaya grade on postoperative MRI evaluation was 2.03 ± 0.81 for the atelocollagen group and 2.24 ± 0.97 for the control group, with a significant difference between the 2 groups (P = .027). Tendon healing failure was observed in 12 patients (6.6%) in the atelocollagen group and 19 patients (10.5%) in the control group, with no statistical difference between the 2 groups (P = .189).CONCLUSIONSAtelocollagen injection during ARCR for small- to medium-sized subacute or chronic rotator cuff tears did not show a benefit in clinical outcomes. However, postoperative MRI showed significantly lower Sugaya grade compared with the control group, with no significant difference in retear rate.LEVEL OF EVIDENCELevel III, retrospective case-control study.

2024-11-01·Arthroscopy: The Journal of Arthroscopic & Related Surgery

Editorial Commentary: Collagen Bridging of Massive Rotator Cuff Tears Using Fascia Lata Autograft Could Provide a Lasting Solution

作者: Jeon, In-Ho ; Kholinne, Erica

Shoulder rotator cuff tears are ideally primarily repaired, but large and massive, chronic, and/or retracted tears result in challenges. In response, innovative solutions include superior capsular reconstruction, tendon transfer, subacromial balloon spacer placement, tuberoplasty, partial repair, and marginal convergence. A recent innovation is to use collagen tissue to bridge repair of compromised tendon. Recent research using fascia lata autograft for supraspinatus tendon reconstruction in a rat model has shown positive outcomes with structural similarity to the normal muscle-tendon interface, decreased fatty infiltration, and increased type I and III collagen, suggesting enhanced mechanical strength. In human subjects, the advantages of autograft outweigh harvest-site morbidity, noting that Dacron, Teflon, and xenograft show poor results. Ideally, a graft might be composed of a degradable scaffold, possess mechanical strength, and amalgamate stem cells, growth factors, and matrix proteins to facilitate host-tissue integration.

项与肩袖损伤相关的新闻（医药）

2024-10-25

·PRNewswire

Regenerative Orthopedics & Sports Medicine Announces Major Partnership for Groundbreaking Stem Cell Research

WASHINGTON, Oct. 25, 2024 /PRNewswire/ -- Regenerative Orthopedics & Sports Medicine (ROSM) is proud to announce a significant partnership with Orthobiologics Research Initiative Inc. (ORI), which has been awarded a prestigious grant from the Maryland Stem Cell Research Fund. This grant will support innovative, non-surgical orthopedic research, aimed at advancing treatments for partial-thickness rotator cuff tears using cutting-edge orthobiologic procedures. The two-year randomized, placebo-controlled trial, set to conclude in December 2026, will explore the efficacy of microfat stem cells in treating rotator cuff injuries—an issue that affects over 2 million Americans annually. With a focus on non-invasive solutions, this research could revolutionize how rotator cuff injuries are treated, potentially reducing the need for surgical intervention. As part of this initiative, ROSM will serve as a key physician partner, bringing their expertise in regenerative medicine to the forefront of this critical research. Importantly, the trial will prioritize Maryland-based enrollment, offering care to underinsured and underserved populations, ensuring equitable access to these pioneering treatments. "We are thrilled to be part of this groundbreaking research," said CEO John Ferrell, MD. "This partnership represents a significant step forward in orthopedic care, and we are excited about the potential impact it could have on patients struggling with rotator cuff injuries." To further advance this important work, the research team is seeking additional donor funds, with a goal of raising $360,000 to drive the study to completion. Public support is essential to ensure that this promising treatment option is fully explored and accessible to those who need it most. Please visit theaestheticsociety.org if you would like to donate and contribute to this transformative research. For more information on how to contribute to this initiative, please visit rosm.org. About Regenerative Orthopedics & Sports Medicine (ROSM) ROSM is a leading provider of regenerative medicine and orthopedic treatments, offering advanced, non-surgical options to treat musculoskeletal conditions. With a commitment to patient-centered care, ROSM physicians are dedicated to improving the quality of life for patients through innovative and effective treatments. Media Contact: Kaitly Lee (443) 505-7150 [email protected] SOURCE Regenerative Orthopedics & Sports Medicine WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

细胞疗法

2024-10-24

·PRNewswire

Inovedis Announces First Patients Treated with the SINEFIX™ Rotator Cuff Repair System in the U.S.

MINNEAPOLIS, Oct. 24, 2024 /PRNewswire/ -- Inovedis Inc., a cutting-edge medical technology start-up, has announced a major milestone in soft tissue repair with the first U.S. patients receiving treatment using their revolutionary SINEFIX™ Rotator Cuff Repair System. This breakthrough system aims to transform the approach to rotator cuff surgery by addressing not just biomechanical fixation, but the critical role of blood flow in tendon-to-bone healing. Rotator cuff repairs have historically been plagued by high failure rates despite advancements in surgical techniques. Many traditional methods focus on strengthening the fixation of the tendon to the bone, but new findings suggest that overemphasis on fixation might actually hinder the healing process. The key lies in minimizing tension and evenly distributing pressure over the largest possible contact surface between tendon and bone, promoting better circulation and biological healing. "Rotator cuff surgery requires biomechanical stability, but excessive tension can compromise blood flow and slow healing," explained Dr. Brian Cohen, an orthopedic surgeon involved in the U.S. launch of SINEFIX™. "Despite improved fixation methods, retear rates remain high. The SINEFIX™ implant controls compression without straining the tendon, preserving blood flow and potentially setting a new standard in rotator cuff repair." The SINEFIX™ system, designed for tendon ruptures up to 2 cm, features a simplified two-step process using a PEEK plate and two PEEK anchors, equipped with additional teeth to prevent tendon slippage. This design keeps the tendon vital by maintaining blood circulation, which is essential for biological healing. The system eliminates the need for complex suture management, making it a more accessible technique for surgeons and improving patient outcomes. "Rotator cuff repair surgeries are among the most common soft tissue procedures, with over half a million performed each year in the U.S. alone," said Dr. Stefan Welte, co-founder of Inovedis and inventor of the SINEFIX™ system. "Unfortunately, traditional methods using suture anchors have not yielded significant improvements in patient recovery. Our vision is to revolutionize biomechanical fixation and enhance biological healing. The success of these first cases in the U.S. brings us closer to that goal." Tom Anstead, CEO of Inovedis Inc., emphasized the importance of the technology in reducing surgery time and cost while enhancing patient care. "The simplicity of SINEFIX™'s surgical technique, which eliminates the need for knot tying, is a critical step toward making this groundbreaking technology available to surgeons worldwide. Our first successful cases in the U.S. mark a significant achievement for our team." As Inovedis continues to pioneer advancements in orthopedic repair, the introduction of SINEFIX™ represents a potential turning point in the treatment of rotator cuff injuries, offering new hope for improved recovery and long-term healing. ABOUT INOVEDIS Inovedis is a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions. Since its founding in 2019, Inovedis has been developing SINEFIX™ to simplify rotator cuff tear surgery and improve patient outcomes. SINEFIX received FDA clearance in 2023. SINEFIX is not approved for sale outside the U.S. To learn more, visit our website and follow us on LinkedIn. MEDIA CONTACT: Ronda Taylor [email protected] SOURCE Inovedis Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2024-09-24

·美通社

史赛克InSpace球囊喜获C码巨大不可修复肩袖撕裂的革命性疗法

上海 2024年9月24日 /美通社/ -- 继在中国获批上市之后，史赛克公司研发生产的可吸收植入式球囊InSpace System（以下简称：InSpace可吸收植入式球囊）又迎来重大突破。 9月20日，经过国家医保局的严格审核，该产品获得了医保医用耗材编码（简称C码），为下一步获得各省挂网采购资格奠定了基础。 lnSpace可吸收植入式球囊是关节镜治疗巨大不可修复肩袖撕裂的突破性解决方案，该解决方案高效且能持续改善患者的病情，国械注进20243130400 今年7月，国家药品监督管理局医疗器械技术审评中心批准了InSpace可吸收植入式球囊在中国的上市申请，用于治疗因外伤或退化引起的巨大、不可修复的全层撕裂的肩袖肌腱。作为截止到2024年全球唯一一款已获批上市的肩关节植入式球囊，该产品可通过微创手术的方式在肩峰下植入，以恢复肩关节平衡，减轻疼痛，增加活动度。InSpace可吸收植入式球囊在华获批标志着巨大不可修复肩袖撕裂的治疗进入微创手术时代。 “我们很高兴能在中国推出InSpace可吸收植入式球囊，” 史赛克中国总经理张绍斌先生表示，“这标志着我们致力于为中国患者提供创新医疗解决方案的又一里程碑。未来，史赛克将持续加速全球创新引进，改善中国患者生活质量，助推‘健康中国2030’战略落地。” 老龄化社会肩袖损伤发病率逐年增加，个人、家庭和社会负担严重肩袖损伤是一种临床常见的肩关节疾病，是指肩关节周围的肌肉、肌腱或韧带损伤。该疾病最常见的起因是肌腱组织随时间逐渐磨损，如果没能得到及时干预，肩袖损伤往往会发展成巨大肩袖撕裂。因此该病症在老年人中较为多发，是肩关节疼痛和功能障碍的最常见原因。 [1] 在全球范围内，以往的解剖学研究和流行病学研究发现，50岁人群中肩袖撕裂的发病率为13%，60岁人群中的发病率为20%，70岁人群中的发病率为31%。随着全球人口老龄化程度的不断进展，肩袖疾病今后必将逐渐成为重要的社会健康问题。 [2] 肩袖撕裂会导致肩关节无力、疼痛，很多日常活动无法完成，如梳头或穿衣动作，在夜间肩关节甚至会疼痛致难以入睡。目前针对巨大不可修复肩袖撕裂的治疗方案主要包括上关节囊重建和反肩置换等，存在创伤大、手术难度高、手术费用高等问题。肩袖损伤疾病负担较重，给社会造成了严重的经济负担。 [3] 前瞻科技推动全球医疗创新，肩袖损伤的手术治疗进入微创时代 InSpace可吸收植入式球囊由植入物和展开器组成，通过关节镜微创操作快速植入，术后即刻恢复肩峰下间隙，帮助恢复肩关节平衡、活动范围及功能，减轻疼痛。随着时间的推移，植入物会在体内发生生物降解。之后经过再教育的肩部肌肉组织能够维持生物学功能，最终可帮助患者日渐回归日常生活功能与活动。与现有的手术方案相比，InSpace可吸收植入式球囊易于使用，植入手术简单直观且易于学习，手术操作时间相对较短，平均需要大约40分钟，并且可以作为日间手术/门诊手术完成。此外，InSpace可吸收植入式球囊还可以通过微创手术完美实现肩袖损伤的微创治疗，具有缩短手术时间、简化操作、降低手术难度、降低病人感染机会、缩短恢复时间、节约医疗费用等多项优势。史赛克InSpace可吸收植入式球囊已获得多个国家和地区的监管批准，并在全球范围内广泛应用。截至目前累计治愈患者41,000例以上。该产品的安全性和有效性已在多项临床研究中得到验证，相关的研究成果已经在全球范围内的顶级学术期刊上发表超过30篇。 [4] 目前治疗不可修复性巨大肩袖撕裂对外科医生而言仍是一项挑战，患者可能需要经历漫长而艰难的康复过程。研究结果表明，InSpace可吸收植入式球囊是一个"游戏规则改变者"。它提供了一种更短、侵入性更小的选择，可以使肩部功能和症状得到持续改善，具有十分显著的临床意义。共赢健康把握中国发展机遇，加速全球创新引进 2021年6月，在海南博鳌乐城国际医疗旅游先行区内成功完成了国内首例治疗巨大肩袖撕裂的可吸收肩关节球囊植入手术。一名58岁巨大肩袖撕裂女性患者，左肩剧烈疼痛多年，基本生活功能逐渐丧失。得益于乐城先行区的先行先试政策，该患者找到了治疗病痛的"良方"。 [5] 史赛克中国加速创新引进的战略布局，使得以InSpace可吸收植入式球囊为代表的全球领先创新器械，得以在美欧主要市场上市当年即通过扩大开放的先行先试政策落户中国海南。今天，InSpace可吸收植入式球囊又成功在中国市场获批上市，为广大外科医生和肩部损伤患者带来新的治疗选择。 [1] 中华医学会运动医疗分会，《勿让"肩周炎"成为肩痛的替罪羊》，2019-10-18 [2] "指南解读 | AAOS肩袖损伤的处理临床实践指南（2019年）"，中华肩肘外科电子杂志，2021年5月 [3] 中华医学会运动医疗分会，《勿让"肩周炎"成为肩痛的替罪羊》，2019-10-18 [4] Elevate Motion – InSpace_Brochure_1000903813RevB，2023 [5] "乐城完成中国内地首例InSpace可吸收肩关节球囊植入手术"，乐城先行区管理局发布，2021年6月20日关于史赛克中国史赛克是全球领先的医疗科技公司，坚守以临床需求为导向的创新理念，开展覆盖患者诊疗全流程的医疗科技创新。作为全球战略布局的重要组成部分，史赛克立足中国市场，加速创新引进，深化本土协作，开展并持续优化本土运营。围绕骨科、医疗设备、神经介入以及医用床和急救设备等领域，史赛克不断为中国医生和患者带去创新的产品和解决方案，并积极推动提升优质医疗资源的可及性和可负担性。史赛克中国，使命所向，为健康未来。