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

Knee Injuries Clinical Trial

— KneePRP  

Official title:

Does Post-Operative Intra-Articular Platelet Rich Plasma Injection Improve Meniscal Repair Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910036
• Other study ID #: 0303544
• Status: Completed
• Phase: Phase 4
• Start date: March 3, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: April 2019
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 20, 2018
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Injuries
• Knee Pain

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Egypt	Rehab Abdelaal ELnemr	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Alexandria University	University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee Pain	visual analogue scale, a line 10cm long, zero represent no pain and 10 represent maximal pain, the patient is asked to put a mark that describe his pain	3 months
Primary	Knee function	Knee injury and osteoarthritis outcome score, assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems	3 months
Primary	meniscal healing process	by ultrasonography	3 months
Secondary	knee pain	visual analogue scale, a line 10cm long, zero represent no pain and 10 represent maximal pain, the patient is asked to put a mark that describe his pain	6 months
Secondary	knee function	Knee injury and osteoarthritis outcome score, assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems	6 months
Secondary	meniscal healing	by ultrasonography	6 months