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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04901273
• Other study ID #: PRP-o65
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Roberta Licciardi, Msc
• Phone: 0516366567
• Email: roberta.licciardi[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Objective parameters - Circumferences	Bilateral trans- and supra- patellar circumferences measurement for comparative analysis	baseline, 1 month, 3 months, 6 and 12 months follow-up