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Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03225092
Recruitment Status : Withdrawn (Unable to recruit enough study participants)
First Posted : July 21, 2017
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Baria, Ohio State University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Observational pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Person has had a total knee arthroplasty (total knee replacement)
  2. Has experienced persistent medial knee pain beyond six months after surgery
  3. Has the presumed diagnosis of pes anserine bursitis
  4. No pain relief with conventional treatments such as arch supports (if one is flatfooted), NSAID's, and at least two local steroid injections

Exclusion Criteria:

  1. Person has had a prior knee surgical procedure other than the total knee arthroplasty or an arthroscopic debridement procedure
  2. Evidence of knee instability, prosthetic loosening, knee infection, radiculopathy, or hip or back pain
  3. Personal history of chronic narcotic or recreational drug use, smoking, psychiatric disorders, or a total hip arthroplasty on the same side of the knee arthroplasty
  4. Body mass index (BMI) of greater than 35

Information from the National Library of Medicine

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


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43202
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Michael Baria, MD, MBA The Ohio State University Wexner Medical Center
Publications:
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Responsible Party: Michael Baria, Sports Medicine Physician, Ohio State University
ClinicalTrials.gov Identifier: NCT03225092    
Other Study ID Numbers: 2017H0153
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Baria, Ohio State University:
Chronic Knee Pain
Status-Post Total Knee Arthroplasty
Platelet Rich Plasma
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases