Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty
Primary Purpose
Knee Pain Chronic, Pes Anserinus Bursitis, Status-Post Total Knee Arthroplasty
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-guided platelet rich plasma injection
Sponsored by
About this trial
This is an interventional treatment trial for Knee Pain Chronic focused on measuring Chronic Knee Pain, Status-Post Total Knee Arthroplasty, Platelet Rich Plasma
Eligibility Criteria
Inclusion Criteria:
- Person has had a total knee arthroplasty (total knee replacement)
- Has experienced persistent medial knee pain beyond six months after surgery
- Has the presumed diagnosis of pes anserine bursitis
- 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:
- Person has had a prior knee surgical procedure other than the total knee arthroplasty or an arthroscopic debridement procedure
- Evidence of knee instability, prosthetic loosening, knee infection, radiculopathy, or hip or back pain
- 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
- Body mass index (BMI) of greater than 35
Sites / Locations
- The Ohio State University Wexner Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRP Injection
Arm Description
Ultrasound-guided platelet rich plasma injection
Outcomes
Primary Outcome Measures
Knee Society Score
Knee Society Scores, a score measurement created by The Knee Society, will be collected as below.
Secondary Outcome Measures
The Hospital for Special Surgery (HSS) Knee Score
Knee Scores, a score measurement created by The Hospital for Special Surgery, will be collected as below.
Visual Analog Scale (VAS) for Pain
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03225092
Brief Title
Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty
Official Title
Efficacy of Platelet-rich Plasma Injections for the Treatment of Persistent Medial Knee Pain After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit enough study participants
Study Start Date
July 18, 2017 (Anticipated)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Chronic, Pes Anserinus Bursitis, Status-Post Total Knee Arthroplasty
Keywords
Chronic Knee Pain, Status-Post Total Knee Arthroplasty, Platelet Rich Plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Observational pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP Injection
Arm Type
Experimental
Arm Description
Ultrasound-guided platelet rich plasma injection
Intervention Type
Biological
Intervention Name(s)
Ultrasound-guided platelet rich plasma injection
Intervention Description
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 Measure Information:
Title
Knee Society Score
Description
Knee Society Scores, a score measurement created by The Knee Society, will be collected as below.
Time Frame
Change from baseline to 6 months is primary outcome. Additional outcomes will be collected at 1 and 3 months after procedure.
Secondary Outcome Measure Information:
Title
The Hospital for Special Surgery (HSS) Knee Score
Description
Knee Scores, a score measurement created by The Hospital for Special Surgery, will be collected as below.
Time Frame
Recorded as a baseline and then at 1, 3, and 6 months post intervention
Title
Visual Analog Scale (VAS) for Pain
Description
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).
Time Frame
Recorded as a baseline and then at 1, 3, and 6 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Person has had a total knee arthroplasty (total knee replacement)
Has experienced persistent medial knee pain beyond six months after surgery
Has the presumed diagnosis of pes anserine bursitis
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:
Person has had a prior knee surgical procedure other than the total knee arthroplasty or an arthroscopic debridement procedure
Evidence of knee instability, prosthetic loosening, knee infection, radiculopathy, or hip or back pain
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
Body mass index (BMI) of greater than 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Baria, MD, MBA
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22357571
Citation
Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
Results Reference
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PubMed Identifier
27817995
Citation
Shi SM, Meister DW, Graner KC, Ninomiya JT. Selective Denervation for Persistent Knee Pain After Total Knee Arthroplasty: A Report of 50 Cases. J Arthroplasty. 2017 Mar;32(3):968-973. doi: 10.1016/j.arth.2016.09.043. Epub 2016 Oct 8.
Results Reference
background
PubMed Identifier
27613710
Citation
Preston S, Petrera M, Kim C, Zywiel MG, Gandhi R. Towards an understanding of the painful total knee: what is the role of patient biology? Curr Rev Musculoskelet Med. 2016 Dec;9(4):388-395. doi: 10.1007/s12178-016-9363-6.
Results Reference
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Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty
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