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NCT07448584
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation). These devices will be evaluated at approximately 3, 6 and 12 months with 3 scoring criteria: Constant score, VAS pain score, and subjective shoulder value score (SSV). At the 6-month and 12-month post-operative visit, tendon healing, and the absence of recurrence of rupture or failure to heal in patients treated with lok™ anchors will also be analyzed. The Sugaya score on ultrasound imaging will be used for this assessment. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be assessed after the surgery and at each follow-up (1, 3, 6 and 12 months after the surgery).
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)
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).
NCT06648941
\- Introduction Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction, particularly among individuals engaged in repetitive overhead activities or advancing in age. The supraspinatus muscle, integral to shoulder function, initiates abduction and provides essential stability to the glenohumeral joint. When the supraspinatus tendon tears and retracts, surgical intervention is often necessary to restore function and alleviate symptoms. (1) Traditional surgical approaches for retracted rotator cuff tears typically involve reattaching the tendon to the greater tuberosity of the humerus. However, severe retraction can lead to challenges during repair, including increased tension on the repair site, potentially compromising healing and increasing the risk of re-tears. • Partial Repair with or without Augmentation: In cases of moderate retraction where complete tendon mobilization is challenging, a partial repair combined with augmentation techniques (e.g., patch augmentation, autografts, allografts) may be considered to optimize tendon-to-bone healing. • Tendon Transfer: For massive irreparable tears or poor tendon quality, tendon transfer procedures (e.g., transferring the teres minor or lower trapezius tendon) may be necessary to restore function and shoulder stability. (2) To address these challenges, medial release of the supraspinatus tendon from its attachment on the medial border of the scapula has emerged as a promising technique. Medial release involves detaching the supraspinatus tendon from its scapular attachment and mobilizing it medially. This technique aims to reduce tension at the repair site, allowing for better tendon apposition and potentially improving healing outcomes. Proponents suggest that medial release enhances biomechanical strength and reduces the risk of postoperative complications such as re-tears. However, the technique's optimal application, outcomes, and comparative effectiveness against traditional repair methods remain subjects of ongoing research and debate within the orthopedic community. (3) Given the complexity and variability of retracted rotator cuff tears, a systematic evaluation of medial release is crucial to clarify its efficacy, safety, and role in surgical management. This protocol outlines a comprehensive framework for evaluating medial release of the supraspinatus tendon in the repair of retracted rotator cuff tears. The study aims to provide evidence-based insights that can guide surgical decision-making, improve patient outcomes, and advance the field of shoulder surgery. Furthermore, medial release may enhance the biomechanical integrity of the repair. By optimizing tendon positioning and tension during repair, it could improve the mechanical strength of the repair construct. This aspect is crucial for achieving durable outcomes and preventing repair failure over time..
NCT01612845
The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.