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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Homologous PRP injections; Procedure: Placebo injection (saline solution)

• Registration Number: NCT04901273
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

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 Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-25
• Study Start: 2021-12-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Homologous PRP	Homologous PRP injections	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.
Saline solution	Placebo injection (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.

Primary Outcome Measures

Name	Time	Method
KOOS-Pain Score	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 Outcome Measures

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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy