Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03889925|
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2019
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: Hymovis Biological: Autologous conditioned plasma||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Participants will be blinded to the type of injection that they receive.|
|Official Title:||Effect of Different Injection Regimens of Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Autologous conditioned plasma group
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Biological: Autologous conditioned plasma
Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
Experimental: Autologous conditioned plasma with hyaluronic acid group
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
- Change in Western Ontario and McMaster University's Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections ]Patient reported outcome measure; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total score. Higher scores indicate worse pain, stiffness, and functional limitations.
- Change in International Knee Documentation Committee Subjective Knee Evaluation Form [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections ]Patient reported outcome measure; Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
- Change in Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections ]Patient reported outcome measure; Consists of 5 subscales; Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life. each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889925
|United States, Florida|
|Andrews Institute for Orthopaedics & Sports Medicine|
|Gulf Breeze, Florida, United States, 32561|