Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03225092|
Recruitment Status : Withdrawn (Unable to recruit enough study participants)
First Posted : July 21, 2017
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Pain Chronic Pes Anserinus Bursitis Status-Post Total Knee Arthroplasty||Biological: Ultrasound-guided platelet rich plasma injection||Early Phase 1|
This study aims to investigate the efficacy of platelet-rich plasma (PRP) injections for the treatment of persistent medial knee pain after total knee arthroplasty (TKA). The investigators hypothesize that PRP injections will provide meaningful pain relief and improved functionality for patients suffering from post-TKA residual pain. The incidence of residual pain after TKA ranges between 10-34%. Many of these patients can be effectively managed by physical therapy, orthotics, and pes anserine bursa corticosteroid injections. However, there remain a number of refractory cases that are frustrating for both the patient and physician. With the advent of interventional pain management, advanced interventions for this clinical problem have focused on selective nerve blocks and ablations targeting the infrapatellar branch of the saphenous nerve. More recently, attention has been paid to the role of patient biology and inflammatory mediators in the development of post-arthroplasty pain (including IL-6 and CRP). If individual patient biology is the foundation of post-TKA pain, then biologic interventions aimed at restoring the balance of these mediators (such as PRP), rather than ablative procedures, seems preferable. Furthermore, while intra-operative PRP has been studied for its effects on wound healing, blood loss, and post-operative pain control, no study has investigated its utility in treating residual medial knee pain after TKA.
All injections will be performed by the same board-certified sports medicine and musculoskeletal ultrasound physician. There will be no activity restrictions following the procedure.
Descriptive statistics will be used to report mean changes in outcome scores. Data will be analyzed with a 2-sample t-test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Observational pilot study|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Platelet-rich Plasma Injections for the Treatment of Persistent Medial Knee Pain After Total Knee Arthroplasty|
|Estimated Study Start Date :||July 18, 2017|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: PRP Injection
Ultrasound-guided platelet rich plasma injection
Biological: Ultrasound-guided platelet rich plasma injection
Each participant will receive a single injection into the pes anserine bursa (using the Arthrex Angel system with a setting of 180cc of peripheral blood and 1% hematocrit concentration) under sterile technique
- Knee Society Score [ Time Frame: Change from baseline to 6 months is primary outcome. Additional outcomes will be collected at 1 and 3 months after procedure. ]Knee Society Scores, a score measurement created by The Knee Society, will be collected as below.
- The Hospital for Special Surgery (HSS) Knee Score [ Time Frame: Recorded as a baseline and then at 1, 3, and 6 months post intervention ]Knee Scores, a score measurement created by The Hospital for Special Surgery, will be collected as below.
- Visual Analog Scale (VAS) for Pain [ Time Frame: Recorded as a baseline and then at 1, 3, and 6 months post intervention ]A patient-reported measurement where the subjects will rate their knee pain level by placing a mark along a 100 millimeter line (with each millimeter corresponding to a number, from 0 to 100, 0 meaning no pain at all and 100 meaning the worst pain possible).
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): NCT03225092
|United States, Ohio|
|The Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43202|
|Principal Investigator:||Michael Baria, MD, MBA||The Ohio State University Wexner Medical Center|