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

NCT04901273 | Recruiting

• 1 other identifier: PRP-o65
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

knee; knee osteoarthritis; PRP; Homologous PRP; PRP injections; injection treatment; Randomized controlled trial; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• KOOS-Pain Score

  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".

  6 months FU

Secondary Outcomes (9)

• KOOS Score

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

• IKDC-Subjective Score

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

• Visual Analogue Scale (VAS)

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

• EQ-VAS

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

• EQ-5D (EuroQoL) Current Health Assessment

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

Study Arms (2)

Homologous PRP

EXPERIMENTAL

This group of patients will be treated with single intra-articular injection of Homologous PRP. At the 6-month follow-up visit, the patient will be informed about the treatment received.

Procedure: Homologous PRP injections

Saline solution

PLACEBO COMPARATOR

This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months.

Procedure: Placebo injection (saline solution)

Interventions

Homologous PRP injections PROCEDURE

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

Homologous PRP

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

Saline solution

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (5)

• 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: 30545242 BACKGROUND

• Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. doi: 10.1007/s00167-011-1837-x. Epub 2011 Dec 28.

  PMID: 22203046 BACKGROUND

• Braun HJ, Kim HJ, Chu CR, Dragoo JL. The effect of platelet-rich plasma formulations and blood products on human synoviocytes: implications for intra-articular injury and therapy. Am J Sports Med. 2014 May;42(5):1204-10. doi: 10.1177/0363546514525593. Epub 2014 Mar 14.

  PMID: 24634448 BACKGROUND

• Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726.

  PMID: 24599205 BACKGROUND

• Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.

  PMID: 16921694 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alessandro Di Martino, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Licciardi, Msc

CONTACT

0516366567; roberta.licciardi@ior.it

Alessandro Di Martino, MD

CONTACT

alessandro.dimartino@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind randomized controlled trial with 1:1 allocation. Patient blinding will be provided during the injection treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm (saline solution ) to the treatment arm (Homologous PRP). 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.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 25, 2021
• Study Start: December 15, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)