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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This is a double-blind randomized controlled trial with 1:1 allocation. Patient blinding will be provided during the injection treatment.

Study Groups

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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.

Group Type EXPERIMENTAL

Homologous PRP injections

Intervention Type PROCEDURE

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

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.

Group Type PLACEBO_COMPARATOR

Placebo injection (saline solution)

Intervention Type PROCEDURE

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

Interventions

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Homologous PRP injections

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No