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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Procedure: Homologous PRP injections; Procedure: Placebo injection (saline solution)

Study type: Interventional

Funder types: Other

Identifiers

NCT04901273

PRP-o65

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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204 participants in 2 patient groups, including a placebo group

Homologous PRP

Experimental group

Description:

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.

Treatment:

Procedure: Homologous PRP injections

Saline solution

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Placebo injection (saline solution)