Effect of PRP Injection After Arthroscopic Meniscal Repair in the Healing Process

NCT ID: NCT03910036

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2018-03-20

Brief Summary

The investigator's hypothesis was that intra-articular knee injection with PRP in patients underwent arthroscopic meniscal repair and didn't receive intra-surgical PRP, may add beneficial effect on post-meniscal repair outcomes regarding pain, functional state of the operated knee as well as healing process.

Detailed Description

The study was done on 30 patients underwent arthroscopic isolated meniscal repairs performed by a single surgeon but unfortunately didn't receive PRP injection during the repair procedure.

Random, double blinded selection of 15 patients to constitute the PRP-group was injected intra-articularly with about 5 ml of PRP in the operated knee joint. The other fifteen patients were not injected and constituted control group. PRP preparation:

Thirty ml of venous blood was taken from every patient and collected in sodium citrated sterile tubes. Platelet concentrates obtained by adjusting centrifuge at 1800 rpm for 15 min to separate erythrocytes, then at 3500 rpm for 10 min to concentrate the platelets. The preparation was done by a single laboratory technician. Thus 5 ml of PRP were obtained, 0.2 mL of 10% calcium chloride was added to the final product to activate the platelets and injected immediately without storage. Procedure Pre-injection guidelines were given to all patients (in PRP group) in the form of stopping steroidal and non-steroidal anti-inflammatory drugs for at least one week before the procedure, as well as stopping any anticoagulant drugs 5 days before the procedure, increasing intake of fluids within the 24 hours prior to the procedure and anti-anxiety medication were required for anxious patients. Injection, under complete aseptic techniques, was performed while the patient was in supine position, and the knee was fully extended, using the lateral approach. Patients were instructed after injection to avoid using the injected leg for 24 hours, to use ice packs over the injected joint and not to use NSAIDs for another one week.

Conditions

Knee Pain; Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

PRP group

15 patients to constitute the PRP-group was injected intra-articularly with about 5 ml of PRP in the operated knee joint

Group Type: EXPERIMENTAL

platelet rich plasma

Intervention Type: BIOLOGICAL

Thirty ml of venous blood was taken from every patient and collected in sodium citrated sterile tubes. Platelet concentrates obtained by adjusting centrifuge at 1800 rpm for 15 min to separate erythrocytes, then at 3500 rpm for 10 min to concentrate the platelets. The preparation was done by a single laboratory technician. Thus 5 ml of PRP were obtained, 0.2 mL of 10% calcium chloride was added to the final product to activate the platelets and injected immediately without storage.

control group

The other fifteen patients were not injected and constituted control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

platelet rich plasma

Thirty ml of venous blood was taken from every patient and collected in sodium citrated sterile tubes. Platelet concentrates obtained by adjusting centrifuge at 1800 rpm for 15 min to separate erythrocytes, then at 3500 rpm for 10 min to concentrate the platelets. The preparation was done by a single laboratory technician. Thus 5 ml of PRP were obtained, 0.2 mL of 10% calcium chloride was added to the final product to activate the platelets and injected immediately without storage.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients aged 18-55 years
• Complete meniscal tear in red-white zone done repaired
• Surgery was done by by a single surgeon

Exclusion Criteria

• Some systemic disorders, such as diabetes, autoimmune diseases, hematological disorders, cardiovascular diseases, infections
• Local knee injuries other than meniscal injury
• Patients receiving treatment with anticoagulants-anti-aggregates
• Use of NSAIDs within 5 days before local PRP injection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alexandria

OTHER

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Abdelaal ELnemr

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rehab A ELnemr, lecturer

Role: PRINCIPAL_INVESTIGATOR

Alexandria University, faculty of medicine

Locations

Rehab Abdelaal ELnemr

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0303544

Identifier Type: -

Identifier Source: org_study_id