Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
EARLY_PHASE1
100 participants
INTERVENTIONAL
2023-10-15
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cannabidiol for Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
NCT06234631
Cannabidiol for Bilateral Total Knee Arthroplasty
NCT04749628
A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
NCT04585230
Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following TKA: A Pilot RCT
NCT03825965
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
NCT03858231
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care
Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days
No interventions assigned to this group
Cannabidiol Oil 100 mg/day
CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively
Cannabidiol Oil
Subjects will self administer CBD sublingually
Cannabidiol Oil 200 mg/day
CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.
Cannabidiol Oil
Subjects will self administer CBD sublingually
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cannabidiol Oil
Subjects will self administer CBD sublingually
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
* able to complete surveys and follow-up visits
Exclusion Criteria
* history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, \*pregnancy.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Foundation for Orthopaedic Research and Education
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute
Tampa, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
USF006030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.