Novel Bioactive Sleeve on Pain and PROMs
ConditionMeniscus Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Reparel Sleeve
- Placebo Sleeve
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Northwell Health
Lead sponsor
Reparel
Collaborator
Source ClinicalTrials.gov