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

The Ohio State University

Status and phase: Withdrawn; Early Phase 1

Conditions: Pes Anserinus Bursitis; Status-Post Total Knee Arthroplasty; Knee Pain Chronic

Treatments: Biological: Ultrasound-guided platelet rich plasma injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03225092

2017H0153

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PRP Injection

Experimental group

Description:

Ultrasound-guided platelet rich plasma injection

Treatment:

Biological: Ultrasound-guided platelet rich plasma injection