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Completed

NCT Number: NCT04454164

Platelet Rich Plasma Injection for Knee Osteoarthritis

The research questions of this study are;

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

This study was designed to find answers of these questions.

The hypotheses of this study are; "PRP treatment is more effective than placebo; PRP treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple dose of PRP affects the effectiveness and duration of PRP as positively compared to single dose of PRP".

The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain and functions in patients with knee OA by comparing it with the placebo control group. Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized, double-blind and placebo control group, with a high level of scientific evidence. Thus, it will be scientifically possible to find answers to the investigators research questions and to prove the investigators hypothesis.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

The power analysis of this study was calculated based on the sample size studies of previous studies. The difference of d = 3 units between the two means is to have a standard deviation of 6 units. The sample size 200 required to detect with 95% power in the 95% confidence interval to detect.

This study covers 324 patients. All patients were selected according to predefined and established inclusion and exclusion criteria.

Inclusion criteria

were: stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging, age between 18 and 80 years, mean Visual Analogue Score (VAS) of >4 of 10 (worst possible pain) over the course of 7 days during the previous month were included on a voluntary basis. Only one knee injection was made to the patients.

Exclusion criteria

were OA secondary to joint inflammatory diseases; patients with 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 three months or arthroscopic lavage in the previous one year or who were receiving immunosuppressive; patients with current use of anticoagulant medications or NSAIDs used in the five days before blood donation, major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation); and patients with a hemoglobin level less than 11.5 g/dL and platelets level less than 100,000/μL or associated co-morbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.

The voluntary patients included in this study were divided into four different groups with a computer-assisted randomization program. This groups; group A (n:67) were given a single injection of PRP, group B (n:69) were given a single injection of normal saline (physiological control/placebo), group C (n:66) were given three injection (one per month) of PRP, group D (n:65) were given three injection of normal saline (one per month) (physiological control/placebo).

All patients were evaluated by a blinded researcher with VAS, Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), KUJALA, knee range of motion (ROM) and knee circumference measurement at 1st, 3rd, 6th, 12th and 24th months after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

PRP

Biological

platelet rich plasma

Other names: platelet rich plasma

Saline

Drug

serum physiologic

Other names: serum physiologic

Primary outcomes

  1. VAS

    Time frame: Baseline VAS score

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

  2. VAS

    Time frame: VAS score at 1st months

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

  3. VAS

    Time frame: VAS score at 3th months

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

  4. VAS

    Time frame: VAS score at 6th months

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

  5. VAS

    Time frame: VAS score at 12th months

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

  6. VAS

    Time frame: VAS score at 24th months

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

  7. KOOS

    Time frame: Baseline KOOS score

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

  8. KOOS

    Time frame: KOOS score at 1st months

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

  9. KOOS

    Time frame: KOOS score at 3th months

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

  10. KOOS

    Time frame: KOOS score at 6th months

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

  11. KOOS

    Time frame: KOOS score at 12th months

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

  12. KOOS

    Time frame: KOOS score at 24th months

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

  13. WOMAC

    Time frame: Baseline WOMAC score

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

  14. WOMAC

    Time frame: WOMAC score at 1st months

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

  15. WOMAC

    Time frame: WOMAC score at 3th months

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

  16. WOMAC

    Time frame: WOMAC score at 6th months

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

  17. WOMAC

    Time frame: WOMAC score at 12th months

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

  18. WOMAC

    Time frame: WOMAC score at 24th months

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

  19. Kujala

    Time frame: Baseline Kujala score

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

  20. Kujala

    Time frame: Kujala score at 1st months

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

  21. Kujala

    Time frame: Kujala score at 3th months

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

  22. Kujala

    Time frame: Kujala score at 6th months

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

  23. Kujala

    Time frame: Kujala score at 12th months

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

  24. Kujala

    Time frame: Kujala score at 24th months

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

Secondary outcomes

  1. Knee movement

    Time frame: 1st, 3rd, 6th, 12th and 24th months

    knee joint range of motion (measured by goniometer as degree)

  2. knee circumference

    Time frame: 1st, 3rd, 6th, 12th and 24th months

    Knee Trans patella circumference

  3. mechanical axis angle

    Time frame: baseline

    angle measured from radiological axes graphs

  4. age

    Time frame: baseline

    age of the patient

  5. stage

    Time frame: baseline

    stage of the osteoarthritis

  6. BMI

    Time frame: baseline

    body mass index

  7. patient global satisfaction

    Time frame: 24 months

    subjective satisfaction level of the patient

Sponsors and collaborators

Lead sponsor

Ferhat Say

Other

Registry information

Official study title

Platelet Rich Plasma In Knee Osteoarthritis: A Prospective, Double-Blind Randomized, Placebo Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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