Back to results

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis (PIKOA)

Primary Purpose

Knee Osteoarthritis

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PRP injection

Placebo injection

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Platelet rich plasma, PRP, Placebo controlled trial

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 40 and 79
Symptomatic knee OA according to ACR criteria evolving for more than 3 months
Predominantly femoro-tibial pain
KL 2 or 3 on femorotibial compartment on X-rays of less than 6 months
ENS ≥ 4/10 (with or without usual analgesic treatments)
Failures or contraindications to conventional treatments (analgesics, NSAIDs)
Patient able to understand the requirements of the trial and having signed a free and informed consent before entering the study
Patient able to read and understand written instructions
Patient able to complete the self-questionnaires
Use of effective contraception in premenopausal women

Exclusion Criteria:

Other pathologies of the lower limbs interfering with the evaluation of knee osteoarthritis (symptomatic hip OA, Lumbar pain…)
Symptomatic contralateral knee OA with NRS ≥ 4/10
Predominant patellofemoral symptoms
Radiographic knee OA stage 1 or 4 of KL
Predominant radiographic patellofemoral OA
History of target knee surgery with material
History of inflammatory or microcrystalline rheumatism
History of fibromyalgia
Morbid obesity (BMI> 40kgs / m2)
Inflammatory flare (KOFUS score ≥ 7)
Use of opioids in the month prior to inclusion
Patient refusing to stop NSAIDs during the study and conventional analgesics 48 hours
History of infection of the target knee
Presence of chondrocalcinosis on the frontal x-ray
Previous PRP injection
Injection of HA or CS into the target knee during the last 3 months
History of hemostasis disorders or taking a curative dose of anticoagulant
Treatment with antiplatelet agents [Acetylsalicylic acid (Aspegic, Kardegic, Duoplavin, Resitune, Asasantine), Clopidogrel (Plavix, Duoplavin), Dipyridamole (Persantine, Cleridium, Asasantine)]
Haematological disease in progress or in remission for less than 5 years (malignant hemopathies, myelodysplasia, autoimmune thrombocytopenia)
Thrombocytopenia (<150,000 platelets)
Patient undergoing treatment with chemotherapy or immunosuppressive drugs
Infection at the time of inclusion (bacterial infection and / or presence of fever and / or taking antibiotics)
Participation in a clinical trial on knee osteoarthritis during the last year
Participation in any clinical trial completed less than 3 months ago
Patient whose mental state does not allow him to understand the nature, objectives and possible consequences of the study
Patient under legal protection (curatorship or guardianship)
Pregnant woman or planning to become pregnant during the study or breastfeeding

Sites / Locations

Florent Eymard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRP group

Placebo group

Arm Description

PRP will be prepared with The Regenkit BCT kit provided by the RegenLab laboratory. This is a 2B medical device with the CE mark. 5mL will be injected in knee under ultrasound guidance. The PRP extracted using this kit is poor in leukocytes, has a platelet concentration multiplied by 1.6 on average compared to circulating blood and is not activated (P2Bbeta according to the PAW classification; 3B according to the Mishra's classification).

5 mL of NaCl will be injected in knee under ultrasound guidance.

Outcomes

Primary Outcome Measures

Change in global pain intensity in the target knee over the past 48 hours as assessed by Numeric Rating Scale (NRS) between week 0 and week 14

Secondary Outcome Measures

Intensity of global pain in the target knee over the last 48 hours evaluated by NRS between week 0 and week 26

WOMAC score

The WOMAC score is a composite score widely used in international studies on knee osteoarthritis. This is a self-administered questionnaire comprising 3 sub-scores assessing pain (5 items), function (17 items) and stiffness (2 items). Each item is measured on a graduated scale from 0 to 100 (100 corresponding to the most severe symptoms). An average out of 100 will be calculated for each sub score and then for the total WOMAC score. The WOMAC score will be calculated before the first injection (W0) and at W8 and W14.

OMERACT-OARSI response

The OMERACT-OARSI response was developed by international scientific societies working on osteoarthritis in order to identify patients with a significant and clinically relevant response to a therapeutic strategy or to a given treatment. It is defined as either an improvement in the WOMAC pain score or the WOMAC score based on at least 50% and at least 20 points out of 100, or an improvement of at least 20% and at least 10 points out of 100 for 2 of the 3 following criteria: WOMAC pain score, WOMAC function score and overall assessment of symptoms by the patient (measured by graduated scale from 0 to 100). This response will be evaluated at W8 and W14.

EQ5D-5L score

The EQ5D-5L score is a composite quality of life score assessing 5 different areas (mobility, personal care, daily activities, pain, anxiety) and validated in osteoarthritis and chronic pain. Each item is measured on a scale of 1 (most favorable condition) to 5 (most unfavorable condition) depending on the severity of symptoms. The EQ5D-5L score will be calculated before the first injection (W0), at W8 and at W14.

Number of level 1 or 2 analgesics consumed

The consumption of analgesics will be evaluated at WO, W8, W14 and W26. The number and dose of level 1 or 2 analgesics consumed during the week preceding the visit will be noted (D-7 to D-2 before each assessment, patients not being authorized to take analgesics within 48 hours before the assessment). A notebook will be given to the patient so that he notes each analgesic taken with dosage and daily frequency.

drug dose of level 1 or 2 analgesics consumed

Evaluation of adverse events

Serum biomarker assay Coll2-1

Serum biomarker assay Coll2-1 NO₂

Serum biomarker assay PIIANP

Full Information

NCT ID

NCT05378815

First Posted

May 9, 2022

Last Updated

May 12, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT05378815

Brief Title

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

Acronym

PIKOA

Official Title

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

September 15, 2024 (Anticipated)

Study Completion Date

May 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Intro: Platelet rich plasma (PRP) is largely used in various musculoskeletal disorders such as chronic tendinopathies but also osteoarthritis (OA). Several therapeutic trials evaluating the effectiveness of intra-articular PRP injections in knee OA as well as meta-analyses have already been published. Most of them have compared PRP to Hyaluronic Acid (HA). Their design was very heterogeneous in terms of PRP characteristics and injection protocol. Moreover, the number of patients included was often very low. Only few studies have compared PRP to placebo (physiological serum) and presented the same methodological limitations (limited number of patients, heterogeneous protocols in terms of number and frequency of injections, characteristics of PRP, etc.). Given the insufficient level of evidence related to these limitations, PRP injections are not recommended in the treatment of symptomatic knee OA by the main scientific societies such as American College of Rheumatology (ACR), Osteoarthritis Research Society International (OARSI), American Academy of Orthopedic Surgeons (AAOS) and French Society of Rheumatology (SFR). Experts in the field agree on the need for a placebo-controlled trial with hihg methodological quality and simple design in order to conclude with a good level of evidence to the benefit or not of this new therapeutic weapon in symptomatic knee osteoarthritis of moderate radiographic severity.

Detailed Description

Hypothesis/Objective: The main objective of this trial is to assess the pain decrease over the last 48 hours assessed by simple numerical scale (NRS) at W14 after 3 weekly injections of PRP (W0, W1 and W2) compared to 3 injections of an equivalent volume of physiological serum in patients suffering from a knee osteoarthritis of moderate radiological severity [Kellgren and Lawrence (KL) 2 or 3]. The secondary objectives will aim to compare the decrease in the level of pain and functional assessed by NRS at W8, WOMAC scores at W8 and W14, by OMERACT-OARSI response at W8 and W14, in EQ5D-5L score at W8 and W14 between PRN and placebo group. We will also assess the decrease in the consumption of analgesics at W8 and W14 and the decrease in serum level of Coll2-1, Coll2-1 NO₂ and increase in PIIANP level at W8 and W14

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Knee osteoarthritis, Platelet rich plasma, PRP, Placebo controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised, double blinded, placebo-controlled trial comparing 3 intra-articular injections of PRP (Regenkit) and NaCl in patients with symptomatic knee osteoarthritis

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

In this trial, the patient, the investigator performing the intra-articular injection and the investigator assessing the outcomes will be blinded

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRP group

Arm Type

Experimental

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

5 mL of NaCl will be injected in knee under ultrasound guidance.

Intervention Type

Procedure

Intervention Name(s)

PRP injection

Intervention Description

3 weekly intra-articular injections of 5mL PRP under ultrasound guidance

Intervention Type

Procedure

Intervention Name(s)

Placebo injection

Intervention Description

3 weekly intra-articular injections of 5mL NaCL under ultrasound guidance

Primary Outcome Measure Information:

Title

Change in global pain intensity in the target knee over the past 48 hours as assessed by Numeric Rating Scale (NRS) between week 0 and week 14

Time Frame

between week 0 and week 14

Secondary Outcome Measure Information:

Title

Intensity of global pain in the target knee over the last 48 hours evaluated by NRS between week 0 and week 26

Time Frame

between week 0 and week 26

Title

WOMAC score

Description

Time Frame

between week 0 and week 26

Title

OMERACT-OARSI response

Description

Time Frame

between week 0 and week 26

Title

EQ5D-5L score

Description

Time Frame

between week 0 and week 26

Title

Number of level 1 or 2 analgesics consumed

Description

Time Frame

between week 0 and week 26

Title

drug dose of level 1 or 2 analgesics consumed

Description

Time Frame

between week 0 and week 26

Title

Evaluation of adverse events

Time Frame

between week 0 and week 26

Title

Serum biomarker assay Coll2-1

Time Frame

between week 0 and week 14

Title

Serum biomarker assay Coll2-1 NO₂

Time Frame

between week 0 and week 14

Title

Serum biomarker assay PIIANP

Time Frame

between week 0 and week 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 40 and 79 Symptomatic knee OA according to ACR criteria evolving for more than 3 months Predominantly femoro-tibial pain KL 2 or 3 on femorotibial compartment on X-rays of less than 6 months ENS ≥ 4/10 (with or without usual analgesic treatments) Failures or contraindications to conventional treatments (analgesics, NSAIDs) Patient able to understand the requirements of the trial and having signed a free and informed consent before entering the study Patient able to read and understand written instructions Patient able to complete the self-questionnaires Use of effective contraception in premenopausal women Exclusion Criteria: Other pathologies of the lower limbs interfering with the evaluation of knee osteoarthritis (symptomatic hip OA, Lumbar pain…) Symptomatic contralateral knee OA with NRS ≥ 4/10 Predominant patellofemoral symptoms Radiographic knee OA stage 1 or 4 of KL Predominant radiographic patellofemoral OA History of target knee surgery with material History of inflammatory or microcrystalline rheumatism History of fibromyalgia Morbid obesity (BMI> 40kgs / m2) Inflammatory flare (KOFUS score ≥ 7) Use of opioids in the month prior to inclusion Patient refusing to stop NSAIDs during the study and conventional analgesics 48 hours History of infection of the target knee Presence of chondrocalcinosis on the frontal x-ray Previous PRP injection Injection of HA or CS into the target knee during the last 3 months History of hemostasis disorders or taking a curative dose of anticoagulant Treatment with antiplatelet agents [Acetylsalicylic acid (Aspegic, Kardegic, Duoplavin, Resitune, Asasantine), Clopidogrel (Plavix, Duoplavin), Dipyridamole (Persantine, Cleridium, Asasantine)] Haematological disease in progress or in remission for less than 5 years (malignant hemopathies, myelodysplasia, autoimmune thrombocytopenia) Thrombocytopenia (<150,000 platelets) Patient undergoing treatment with chemotherapy or immunosuppressive drugs Infection at the time of inclusion (bacterial infection and / or presence of fever and / or taking antibiotics) Participation in a clinical trial on knee osteoarthritis during the last year Participation in any clinical trial completed less than 3 months ago Patient whose mental state does not allow him to understand the nature, objectives and possible consequences of the study Patient under legal protection (curatorship or guardianship) Pregnant woman or planning to become pregnant during the study or breastfeeding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Florent Eymard, MD, PhD

Phone

01 49 81 27 02

Ext

+33

florent.eymard@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Lila Kaci

Phone

01 49 81 36 24

Ext

+33

lila.kaci@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florent Eymard, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Study Director

Facility Information:

Facility Name

Florent Eymard

City

Créteil

ZIP/Postal Code

94010

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florent Eymard, MD,PHD

Phone

0149812702

Ext

+33

florent.eymard@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

We'll reach out to this number within 24 hrs