Status:
RECRUITING
Novel Bioactive Sleeve on Pain and PROMs
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Reparel
Conditions:
Meniscus Tear
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
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 mo...
Detailed 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/c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06041321
Start Date
December 6 2023
End Date
October 1 2027
Last Update
January 18 2024
Active Locations (1)
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1
Orlin and Cohen Orthopedics
Woodbury, New York, United States, 11797