A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis… (NCT06000410) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
United States594 participantsStarted 2023-09-06
Plain-language summary
This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males or females 18 years of age or older
* Diagnosis of OA of the index knee by a combination of clinical and radiographic findings.
* OA of the index knee with Kellgren and Lawrence radiographic classification (Grades 2-4 inclusive),
* Patients who have failed to adequately respond for at least 6 months to at least two osteoarthritis therapies within the last 12 months
* Overall index knee pain score above minimum required WOMAC Pain scale.
* Body mass index \< 40 kg/m2
* Using birth control, sterile or post-menopausal.
* Able to understand and provide written informed consent
Exclusion Criteria:
* Kellgren and Lawrence radiographic grade 1 OA of the knee
* Use of pain medication less than 5 days before the baseline visit
* Regular use of anticoagulants
* Symptoms that could indicate meniscal displacement or an IA loose body.
* Corticosteroid injection into the index knee within 3 months prior to screening.
* Viscosupplement or any other autologous or allogeneic product into the index knee within 6 months prior to screening.
* Patients with known hypersensitivity reactions to ASA or any of its constituents.
* Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study
* Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study
* Acute index knee trauma within 3 months prior to screening
* Knee effusion requiring aspiration of the index or…
What they're measuring
1
The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients