Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT03225092
Status:
WITHDRAWN
Last Update Posted:
2020-04-17
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
Efficacy of Platelet-rich Plasma Injections for the Treatment of Persistent Medial Knee Pain After Total Knee Arthroplasty
Status:
WITHDRAWN
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit enough study participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the potential effects of platelet rich plasma for the treatment of persistent medial knee pain after total knee arthroplasty. All study participants will receive PRP injections and will be followed up to see if any benefit in regards to pain and/or function is achieved.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: