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

Homologous PRP Versus Placebo in the Infiltrative Treatment of 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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Homologous PRP injections; Procedure: Placebo injection (saline solution)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta Licciardi, MSc; Phone Number: 0516366567; Email: roberta.licciardi@ior.it
• Study Contact Backup: Name: Alessandro Di Martino, MD; Email: alessandro.dimartino@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Alessandro Di Martino, MD; Phone Number: 051 6366567; Email: alessandro.dimartino@ior.it
    • Contact: Roberta Licciardi, MSc; Phone Number: 051 6366567; Email: roberta.licciardi@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients undergoing knee surgery within the previous 12 months;
2. Patients with malignant neoplasms;
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with hematologic diseases (coagulopathies);
6. Patients with metabolic disorders of the thyroid gland;
7. Patients abusing alcoholic beverages, drugs or medications
8. Body Mass Index > 35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Homologous PRP; 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; Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.
Placebo Comparator: Saline solution; 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); Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS Score	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	baseline, 1 month, 3 months, 6 and 12 months follow-up
IKDC-Subjective Score	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.	baseline, 1 month, 3 months, 6 and 12 months follow-up
Visual Analogue Scale (VAS)	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".	baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-VAS	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).	baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-5D (EuroQoL) Current Health Assessment	EQ-5D is useful to evaluate the quality life of the patients	baseline, 1 month, 3 months, 6 and 12 months follow-up
Tegner Activity Level Scale	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.	baseline, 1 month, 3 months, 6 and 12 months follow-up
Objective parameters- Range of Motion	Evaluation of the Range of Motion for comparative analysis.	baseline, 1 month, 3 months, 6 and 12 months follow-up
Patient Acceptable Symptom State (PASS)	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.	baseline, 1 month, 3 months, 6 and 12 months follow-up
Objective parameters - Circumferences	Bilateral trans- and supra- patellar circumferences measurement for comparative analysis	baseline, 1 month, 3 months, 6 and 12 months follow-up

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Alessandro Di Martino, MD, Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: osteoarthritis; knee osteoarthritis; Randomized controlled trial; knee; PRP; injection treatment; Homologous PRP; PRP injections
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PRP-o65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No