Condition category
Musculoskeletal Diseases
Date applied
30/08/2019
Date assigned
16/09/2019
Last edited
05/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://orto.lv/en

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

Publication citations

Additional files

Editorial Notes

02/09/2019: Trial’s existence confirmed by Rigas Stradins University (RSU) Êtikas Komitejas.