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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying patients with rotator cuff injuries who are undergoing arthroscopic rotator cuff repair surgery. This study collects real-world data on the outcomes of using the REGENETEN Bioinductive Implant System, a medical device designed to manage and protect rotator cuff tendon injuries where there has been no significant loss of tendon tissue. The registry involves multiple centers across the United Kingdom, Europe, and Australia and plans to enroll up to 400 patients. Participants will receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant as part of their standard medical care. The implant is intended to support tendon healing in either partial or full thickness tendon tears. This is a prospective, single-arm study without a comparison group, focusing on collecting data after surgery. Patients will be followed and evaluated at multiple time points up to two years after surgery. Assessments include quality of life, arm and shoulder function, shoulder pain levels, and overall shoulder evaluation using several validated scoring systems. Data will be collected at baseline before surgery and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery to monitor recovery and outcomes over time.

Age: 18Years +All Genders
19 locations
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Actively Recruiting

Researchers are collecting real-world data to observe the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease. This study includes both prospective and retrospective groups to better understand how this motion preservation disc performs in everyday clinical settings. The focus is on patients who have had or will have the Synergy Disc implanted to treat cervical disc degeneration. Participants will receive the Synergy Cervical Disc System, which is designed to preserve motion after disc surgery. Eligible patients have undergone or are scheduled for disc reconstruction from C3 to C7 levels following one or more discectomies. The trial includes patients with symptoms caused by nerve root or spinal cord compression due to herniated discs or bone growths, confirmed by patient history and imaging. All patients will have previously tried at least 6 weeks of conservative treatment without adequate relief. During the study, participants will be monitored for up to 12 months. Researchers will assess neck function using the Neck Disability Index and track any adverse events related to the device or procedures. The study gathers information from medical records and patient reports to evaluate safety and performance over time, enhancing understanding of this treatment in routine practice.

Age: 21Years +All Genders
1 location