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Study Comparing a New Bioactive Leg Sleeve to a Placebo Sleeve for Reducing Pain and Improving Recovery After Meniscus Surgery
Led by Northwell Health · Updated on 2024-01-18
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new bioactive leg sleeve called the Reparel Sleeve, comparing it to a placebo sleeve that looks and feels similar. This study aims to see if the Reparel Sleeve can reduce pain and improve patient-reported outcomes after partial arthroscopic meniscectomy or meniscus repair. The study will include about 100 patients and will assess pain, satisfaction, physical therapy time, and motor function over time. Participants will be randomly assigned to wear either the Reparel Sleeve, made from fabric embedded with a special nano-sized material designed to reflect energy and promote healing, or a generic black placebo sleeve without this technology. Both sleeves come in various sizes and have similar compression and feel. The study is blinded, meaning neither participants nor researchers know who is receiving which sleeve. Participants will complete questionnaires before surgery and at several time points afterward, including 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Researchers will track pain using a visual scale, patient satisfaction, range of motion, and other outcome measures. The study will monitor progress and safety throughout the two-year follow-up period to evaluate the sleeves effects on healing and pain control.
CONDITIONS
Brief Title
Novel Bioactive Sleeve on Pain and PROMs
Research Team
N
Nadia Baichoo, MA
S
Summer Koepplin
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