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NCT Number: NCT07329361

Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis

Evaluation of intra-articular injections in knee osteoarthritis using frozen-stored PRP. Compared with intra-articular injections of PRP applied at the time of collection.

Recruiting

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthroscopic Surgery Unit, MiKS Hosptial

Vitoria-Gasteiz, Araba/Álava, 01010, Spain

Location status: Recruiting

Location contact

Diego Delgado

CONTACT

[email protected]

0034 945 25 20 77

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both sexes.
  • Aged between 40 and 85 years old.
  • Diagnosed with osteoarthritis through clinical radiological examination.
  • Joint pain equal to or less than 75 points on the KOOS (pain).
  • Radiological severity grades 1, 2, and 3 according to the Ahlbäck scale.
  • Indication for intra-articular PRP infiltration.
  • Body Mass Index values between 20 and 35.
  • Negative serological tests for syphilis, HIV, HBV, and HCV.
  • Possibility of observation during the follow-up period.
  • Signature of informed consent.

Exclusion criteria

  • Body mass index >35
  • Diagnosed polyarticular disease.
  • Previous arthroscopy in the last year.
  • Severe mechanical deformity.
  • Intra-articular hyaluronic acid injection in the last 12 months.
  • Intra-articular corticosteroid or PRP injection in the last 6 months.
  • Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
  • Anemia or other hematological disorders.
  • Positive serological tests for SYPHILIS, HIV, HBV, and HCV.
  • Undergoing immunosuppressive treatments.
  • Poorly controlled diabetes mellitus.
  • Patients allergic to paracetamol.
  • Pregnancy or breastfeeding.

Treatment and study plan

Platelet Rich Plasma

Other

Platelet-rich plasma stored by freezing

Primary outcomes

  1. KOOS - Knee Injury and Osteoarthritis Outcome Score

    Time frame: 6 months

    From 0 (worst outcome) to 100 (best outcome)

Secondary outcomes

  1. KOOS - Knee Injury and Osteoarthritis Outcome Score

    Time frame: 2 months

    From 0 (worst outcome) to 100 (best outcome)

  2. VAS - Visual Analog Scale

    Time frame: 2 months

    From 0 (best outcome) to 10 (worst outcome)

  3. VAS - Visual Analog Scale

    Time frame: 6 months

    From 0 (best outcome) to 10 (worst outcome)

  4. Lequesne Index

    Time frame: 2 months

    A patient-completed questionnaire used to measure the severity of osteoarthritis assessing pain and function.

    From 0 (best outcome) to 24 (worst outcome)

  5. Lequesne Index

    Time frame: 6 months

    A patient-completed questionnaire used to measure the severity of osteoarthritis assessing pain and function.

    From 0 (best outcome) to 24 (worst outcome)

Sponsors and collaborators

Lead sponsor

MiKS Hospital

Other

Registry information

Official study title

Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

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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