An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2 mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis (Knee)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. (FDA regulated - HCT/P regulation) Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 30 days, 90 days, 180 days and 365 days. Patient will receive a phone call 24 hours after the injection to monitor any immediate potential adverse events.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Assistants not part of the study used a randomizer generating software to randomly assign a patient a dose. The randomly assigned dose was put in a sealed envelope labeled with the corresponding number and was recorded. Prior to the injection, a medical assistant not involved in the study retrieves the envelope to determine the dose, prepares the injection, then seals the syringe in black tape before giving it to the research staff who then performs the injection.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 80 years
- Gender
- Both males and females
Description
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL). 90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in tr...
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL). 90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms. It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.
Tracking Information
- NCT #
- NCT04612023
- Collaborators
- Not Provided
- Investigators
- Study Chair: Nikil Chari Research Assistant Study Chair: Jacob Barnhart Research Assistant
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