Overview
A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.
Description
This is a blinded randomized prospective study comparing two postoperative leg sleeves. The novel bioactive sleeve (Reparel Leg Sleeve) will be compared to a regular black sleeve with a similar feel/compression. The main hypothesis for this study is that postoperative use of a novel bioactive sleeve after partial arthroscopic meniscectomy/meniscus repair will decrease pain and improve patient reported outcome scores faster and more reliably than the control non-bioactive sleeve. In order to test this hypothesis, approximately 100 patients scheduled for meniscectomy/meniscus repair will be randomized to one of the two arms in order to minimize bias. The following variables will be assessed: patient reported outcomes (VAS, KOOS JR, VR12, and KSS Satisfaction), physical therapy time, motor testing. Each patient will fill out a series of PROMs preoperatively, and post operatively at the 1-week, 2-week, 6-week, 3-month, 6-month, 1 year, and 2-year mark.
Eligibility
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, over the age of 18, undergoing a meniscectomy or meniscus repair
- In good general health as evidenced by medical history
- Under 45th percentile BMI
- Willing to adhere to the study intervention regimenregimen.
- Kellgren-Lawrence grade 2 or less
Exclusion Criteria:
- Febrile illness within 3 months
- BMI over 40
- Treatment with another investigational drug or other intervention within 6 months
- Kellgren-Lawrence grade 3 or more or 4
- History of autoimmune disease, circulatory disease, or vascular disorder