Plain English Summary
Background and study aims
Osteoarthritis (OA) is a condition that causes joints to become painful and stiff that results from the breakdown of joint cartilage and underlying bone. Platelet-rich plasma (PRP) injections bathe troubled cells in a concentrated mixture of platelets from patients own blood. Although it is not exactly clear how PRP works, laboratory studies have shown that it can potentially speed up the healing process in some injuries. Triamcinolone acetonide is a synthetic corticosteroid used topically to treat various skin conditions, to relieve the discomfort of mouth sores, and intra-articularly (in the joints) to treat various joint conditions. The aim of this study was to compare intra-articular injections of autologous PRP with intra-articular injections of corticosteroid to relieve the pain caused by OA.
Who can participate?
Patients older than 55 years with a history of chronic pain, swelling and/or reduced range of motion in the knee joint, confirmed to be OA.
What does the study involve?
Patients who met inclusion criteria were divided into two groups by random selection. Patients randomized to group 1 (platelet-rich plasma - PRP) received one intra-articular injection of autologous PRP. Patients randomized to group 2 (corticosteroid - CS) received an intra-articular injection of triamcinolone acetonide.
What are the possible benefits and risks of participating?
Patients may experience an improvement or no improvement in symptoms.
Where is the study run from?
ORTO Klinika LTD, Latvia
When is the study starting and how long is it expected to run for?
April 2016 to May 2017
Who is funding the study?
ORTO KLĪNIKA, Latvia
Who is the main contact?
Dr Andrej Elksnin-Finogejev
andrejs.finogejevs@orto.lv
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andrej Elksnin-Finogejev
ORCID ID
Contact details
Bukultu iela 1a
Riga
LV-1005
Latvia
+371 67016720
andrejs.finogejevs@orto.lv
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
GO-CS
Study information
Scientific title
Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a one-year follow up
Acronym
PRP
Study hypothesis
We hypothesized that intraarticular injection of PRP reduces pain in a very-short term follow up (one week) similar to triamcinolone acetonide and leads to an equal or more effective analgesic and lasting functional recovery (one year)
Ethics approval
1. Approved 10/02/2016, Rigas Stradins University (RSU) Êtikas Komitejas (Prof Olafs Brüvers, Riga, Dzirciema 16, LV-1007, Latvia; +37167409101), ref: E-9(2)
2. Approved 15/04/2016, Rīgas Austrumu klīniskās universitātes slimnīcas atbalsta fonda Medicīnisko un biomedicīnisko pētījumu ētikas komiteja (Rīga, Hipokrāta iela 2, LV1038, Latvia; +37 20281174; etika@aslimnica.lv), ref: 57/2016
Study design
Single-centre prospective randomized controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Knee osteoarthritis
Intervention
Patients suffering knee pain were redirected to the one physician of the clinical team involved in the trial who evaluated suitability.
Patients who met inclusion criteria were divided into two groups of 20 patients each by random selection. Patients randomized to group 1 (platelet-rich plasma - PRP) received one intra-articular injection of autologous PRP. Patients randomized to group 2 (corticosteroid - CS) received an intra-articular injection of corticosteroid. The randomization of patients was done using a randomization software list.
Pain VAS score at 1 year (change from baseline - V1) was considered the primary outcome variable. Secondary outcomes were International Knee Documentation Committee (IKDC 2000 form) scale and Knee Society Score (KSS) at any time point from: one week (V2), 5 weeks (V3), 15 weeks (V4) and 30 weeks (V5). VAS scores at short-term (1 week) was considered a secondary outcome.
The first assessment was performed at 1 week after the infiltration (V1) to evaluate if PRP clinical improvement was similar or superior to corticosteroid. Patients in the corticosteroid group received intraarticular 1 mL of 40 mg/mL of triamcinolone acetonide (Kenalog®) and 5 mL of 2 % of lidocaine, which was mixed in one syringe. A complete evacuation of intra-articular fluid, if present, was performed before PRP and CS were injected intraarticular. The injecting physician neither the patient was blinded to treatment. All the baseline and follow-up visits were performed by the blinded evaluator who was blinded to the treatment throughout the study. The intra-articular knee injection was performed under sterile conditions without any local or general anesthesia with a 20-G x 2.75 70 mm needle using an anterolateral approach. Echographic control (Philips Affinity 70) allowed a proper needle position by direct visualization of the liquid PRP/CS injected. After manipulation aseptic bandage was used with local cool compression for 15 minutes. Nonsteroidal anti-inflammatory drugs were prohibited for 10 days following the injection.
Intervention type
Drug
Phase
Phase I
Drug names
Platelet-rich plasma, triamcinolone acetonide - Kenalog®
Primary outcome measure
Pain VAS score at 1 year (change from baseline)
Secondary outcome measures
1. International Knee Documentation Committee (IKDC 2000 form) scale and Knee Society Score (KSS) at any time point: one week (V2), 5 weeks (V3), 15 weeks (V4) and 30 weeks (V5).
2. VAS scores at short-term (1 week)
Overall trial start date
01/11/2015
Overall trial end date
30/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients older than 55 years with a history of chronic pain, swelling and/or reduced range of motion in the knee joint
2. Clinical and radiological confirmation of OA of the knee (Kellgren – Lawrence KL grades II-III) was verified by assessing X-Ray images in anteroposterior and lateral projections
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Posttraumatic knee
2. Pregnancy, breastfeeding
3. Oncological diseases
4. Endocrine diseases (gout, diabetes)
5. Autoimmune diseases (rheumatoid arthritis)
6. Acute/chronic infectious disease, blood clotting disorders (thrombocytopenia, coagulopathy)
7. Previous interventions on the knee joint (i.e. punctures, blockades, arthroscopy)
8. Received consistent hormonal therapy or non-steroidal anti-inflammatory drugs (NSAIDs) within 10 days prior to the intervention
Recruitment start date
01/04/2016
Recruitment end date
30/05/2017
Locations
Countries of recruitment
Latvia
Trial participating centre
ORTO Klinika LTD
Bukultu iela 1a
Riga
LV-1005
Latvia
Sponsor information
Organisation
ORTO KLĪNIKA
Sponsor details
Bukultu iela 1
Rīga
LV-1005
Latvia
+371 67016720
office@orto.lv
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
ORTO KLĪNIKA
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published in Journal of Orthopaedic Surgery and Research
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
30/09/2019
Participant level data
Other
Basic results (scientific)
Publication list