Clinical trial NCT03225092: 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
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Knee Pain Chronic
Pes Anserinus Bursitis
Status-Post Total Knee Arthroplasty
Keywords: Chronic Knee Pain
Status-Post Total Knee Arthroplasty
Platelet Rich Plasma
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational pilot study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Knee Society Score
timeFrame: Change from baseline to 6 months is primary outcome. Additional outcomes will be collected at 1 and 3 months after procedure.
Secondary outcomes:
measure: The Hospital for Special Surgery (HSS) Knee Score
timeFrame: Recorded as a baseline and then at 1, 3, and 6 months post intervention
measure: Visual Analog Scale (VAS) for Pain
timeFrame: Recorded as a baseline and then at 1, 3, and 6 months post intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michael Baria, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.