A new clinical study led by Samsung Medical Center is currently recruiting participants to investigate the impact of digital therapeutics on shoulder function recovery following rotator cuff repair surgery. The trial, registered on ClinicalTrials.gov and scheduled to begin soon, holds significant potential for advancing postoperative care practices.
How does the trial assess efficacy and safety?
The trial aims to evaluate the performance and safety of digital therapeutics in improving shoulder mobility, strength, and pain management post-surgery. Participants will undergo monitored rehabilitation over the study period, with outcomes compared to traditional postoperative care methods. The research adheres to rigorous medical device development standards, focusing on patient safety and efficacy of interventions.
What interventions are being studied?
Samsung Medical Center’s study splits participants into two groups. One will utilize digital therapeutics, including technology-enabled recovery tools aimed at guiding and monitoring rehabilitation. The other group will receive standard care practices currently in use for rotator cuff tear arthropathy surgeries.
Digital therapeutics focus on augmented engagement and personalized therapy protocols, leveraging innovative medical devices to document and enhance progress.
Who qualifies for participation?
Eligible candidates include individuals recovering from rotator cuff tear arthropathy surgery. Participants must meet specific inclusion criteria set forth by the study team to ensure data validity and patient safety. Active recruitment is ongoing, and interested individuals can find further details through the provided ClinicalTrials.gov link.
Frequently Asked Questions
- What is the study duration?
The study duration will depend on patient recovery timelines and therapy completion. - Is the trial limited to specific locations?
Samsung Medical Center, based in South Korea, is overseeing the trial. Geographic limitations may apply. - Are the interventions FDA-approved?
Digital therapeutics in this trial align with regulatory standards but may still be in pre-approval stages. - How can people apply?
Application involves contacting the study organizers directly via the ClinicalTrials.gov record.
Summary and implications
The Samsung Medical Center’s clinical trial represents a significant step in advancing digital therapeutics for shoulder function improvement after rotator cuff repair. By evaluating methodologies that merge technology with rehabilitation science, the study seeks to provide evidence-based solutions for postoperative care.
Quality and regulatory teams, as well as other clinical professionals, should consider monitoring the progress and findings of this research. Successful outcomes may inform future standards of care and device use.
Disclaimer
This article is for informational purposes only and does not constitute legal, medical, or regulatory advice. Readers should consult qualified professionals before making any healthcare, policy, or device-related decisions.
Full announcement details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07255534?term=medical+device