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NCT Number: NCT04901273

Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Unilateral involvement;
  • Signs and symptoms of degenerative pathology of the knee cartilage;
  • Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
  • Ability and consent of patients to actively participate in clinical follow-up;
  • Signature of informed consent

Exclusion criteria

  • Patients undergoing knee surgery within the previous 12 months;
  • Patients with malignant neoplasms;
  • Patients with rheumatic diseases;
  • Patients with diabetes;
  • Patients with hematologic diseases (coagulopathies);
  • Patients with metabolic disorders of the thyroid gland;
  • Patients abusing alcoholic beverages, drugs or medications
  • Body Mass Index > 35

Treatment and study plan

Homologous PRP injections

Procedure

Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.

Placebo injection (saline solution)

Procedure

Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by osteoarthritis

Primary outcomes

  1. KOOS-Pain Score

    Time frame: 6 months FU

    KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".

Secondary outcomes

  1. KOOS Score

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items).

    Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale

  2. IKDC-Subjective Score

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.

  3. Visual Analogue Scale (VAS)

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable".

  4. EQ-VAS

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).

  5. EQ-5D (EuroQoL) Current Health Assessment

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    EQ-5D is useful to evaluate the quality life of the patients

  6. Tegner Activity Level Scale

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency.

  7. Objective parameters- Range of Motion

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    Evaluation of the Range of Motion for comparative analysis.

  8. Patient Acceptable Symptom State (PASS)

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.

  9. Objective parameters - Circumferences

    Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up

    Bilateral trans- and supra- patellar circumferences measurement for comparative analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Di Martino, MD

CONTACT

[email protected]

Roberta Licciardi, Msc

CONTACT

[email protected]

0516366567

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 25, 2021
Registry last updated
Aug 3, 2025

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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