NCT04454164

Brief Summary

The research questions of this study are;

  1. 1.Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)?
  2. 2.What are the indications for PRP treatment?
  3. 3.Which patients are the most suitable for the PRP treatment method?
  4. 4.How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages affect the success of the PRP treatment?
  5. 5.Is there any advantage of multiple PRP doses?
  6. 6.What is the therapeutic effect of placebo?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for early_phase_1 knee-osteoarthritis

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

June 24, 2020

Last Update Submit

June 30, 2020

Conditions

Knee OsteoarthritisCartilage Degeneration

Keywords

platelet-rich plasmaplacebogrowth factorsosteoarthritis

Outcome Measures

Primary Outcomes (24)

  • VAS

    Visual Analogue scale (0-10 higher scores mean a worse outcome)

    Baseline VAS score

  • VAS

    Visual Analogue scale (0-10 higher scores mean a worse outcome)

    VAS score at 1st months

  • VAS

    Visual Analogue scale (0-10 higher scores mean a worse outcome)

    VAS score at 3th months

  • VAS

    Visual Analogue scale (0-10 higher scores mean a worse outcome)

    VAS score at 6th months

  • VAS

    Visual Analogue scale (0-10 higher scores mean a worse outcome)

    VAS score at 12th months

  • VAS

    Visual Analogue scale (0-10 higher scores mean a worse outcome)

    VAS score at 24th months

  • KOOS

    Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)

    Baseline KOOS score

  • KOOS

    Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)

    KOOS score at 1st months

  • KOOS

    Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)

    KOOS score at 3th months

  • KOOS

    Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)

    KOOS score at 6th months

  • KOOS

    Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)

    KOOS score at 12th months

  • KOOS

    Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)

    KOOS score at 24th months

  • WOMAC

    Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)

    Baseline WOMAC score

  • WOMAC

    Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)

    WOMAC score at 1st months

  • WOMAC

    Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)

    WOMAC score at 3th months

  • WOMAC

    Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)

    WOMAC score at 6th months

  • WOMAC

    Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)

    WOMAC score at 12th months

  • WOMAC

    Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)

    WOMAC score at 24th months

  • Kujala

    Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)

    Baseline Kujala score

  • Kujala

    Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)

    Kujala score at 1st months

  • Kujala

    Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)

    Kujala score at 3th months

  • Kujala

    Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)

    Kujala score at 6th months

  • Kujala

    Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)

    Kujala score at 12th months

  • Kujala

    Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)

    Kujala score at 24th months

Secondary Outcomes (7)

  • Knee movement

    1st, 3rd, 6th, 12th and 24th months

  • knee circumference

    1st, 3rd, 6th, 12th and 24th months

  • mechanical axis angle

    baseline

  • age

    baseline

  • stage

    baseline

  • +2 more secondary outcomes

Study Arms (4)

PRP group

EXPERIMENTAL

Intraarticular 5 ml single PRP injection

Biological: PRP

Saline group

PLACEBO COMPARATOR

Intraarticular 5 ml single saline injection

Drug: Saline

Multiple PRP group

EXPERIMENTAL

Intraarticular 3 dose of 5 ml PRP injection (0, 1, 3 month injection)

Biological: PRP

Multiple saline group

PLACEBO COMPARATOR

Intraarticular 3 dose of 5 ml saline injection (0, 1, 3 month injection)

Drug: Saline

Interventions

PRPBIOLOGICAL

platelet rich plasma

Also known as: platelet rich plasma
Multiple PRP groupPRP group
SalineDRUG

serum physiologic

Also known as: serum physiologic
Multiple saline groupSaline group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging
  • mean VAS pain score of \>4 of 10 (worst possible pain) over the course of 7 days during the previous month

You may not qualify if:

  • OA secondary to joint inflammatory diseases,
  • generalized OA,
  • metabolic diseases of the bone,
  • coexisting backache,
  • the presence of hematological disease (coagulopathy),
  • bilateral symptomatic lesions and advanced stages (grade 4) of OA,
  • patients who had received intra-articular injections within 3 months or arthroscopic lavage in the previous 1 year,
  • patients who were receiving immunosuppressive,
  • patients with current use of anticoagulant medications,
  • NSAIDs used in the 5 days before blood donation,
  • major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation),
  • patients with a hemoglobin level less than 11.5 g/dL,
  • platelets level less than 100,000/μL,
  • associated comorbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic and Trauma, Faculty of Medicine, Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (7)

  • Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.

    PMID: 30611335BACKGROUND

  • Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.

    PMID: 26831629BACKGROUND

  • Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.

    PMID: 23299850BACKGROUND

  • Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.

    PMID: 26233594BACKGROUND

  • Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.

    PMID: 30545242BACKGROUND

  • Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.

    PMID: 25952818BACKGROUND

  • Yurtbay A, Say F, Cinka H, Ersoy A. Multiple platelet-rich plasma injections are superior to single PRP injections or saline in osteoarthritis of the knee: the 2-year results of a randomized, double-blind, placebo-controlled clinical trial. Arch Orthop Trauma Surg. 2022 Oct;142(10):2755-2768. doi: 10.1007/s00402-021-04230-2. Epub 2021 Oct 27.

    PMID: 34705072DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D. Associate Professor

Study Record Dates

First Submitted

June 24, 2020

First Posted

July 1, 2020

Study Start

June 1, 2018

Primary Completion

August 23, 2019

Study Completion

January 1, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations

TU(1)