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

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT03910036

Collaborator

University of Alexandria (Other)

Enrollment

Location

Arms

12.6

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Pain Knee Injuries	Biological: platelet rich plasma	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model 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. 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.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. 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.

Masking:

Single (Outcomes Assessor)

Masking Description:

the outcome measures assessors were blinded to subjects who receive injection and those who didn't

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 3, 2017

Actual Primary Completion Date :

Dec 5, 2017

Actual Study Completion Date :

Mar 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRP group 15 patients to constitute the PRP-group was injected intra-articularly with about 5 ml of PRP in the operated knee joint	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.
No Intervention: control group The other fifteen patients were not injected and constituted control group.

Arm

Intervention/Treatment

Experimental: PRP group

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

Biological: platelet rich plasma

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

knee Pain [3 months]
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
Knee function [3 months]
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
meniscal healing process [3 months]
by ultrasonography

Secondary Outcome Measures

knee pain [6 months]
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
knee function [6 months]
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
meniscal healing [6 months]
by ultrasonography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehab Abdelaal ELnemr	Alexandria		Egypt	123456

Sponsors and Collaborators

Alexandria University
University of Alexandria

Investigators

Principal Investigator: Rehab A ELnemr, lecturer, Alexandria University, faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rehab Abdelaal ELnemr, lecturer, Alexandria University

ClinicalTrials.gov Identifier:

NCT03910036

Other Study ID Numbers:

0303544

First Posted:

Apr 10, 2019

Last Update Posted:

Apr 11, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Rehab Abdelaal ELnemr, lecturer, Alexandria University

PRP

regeneration

ultrasound

Additional relevant MeSH terms:

Knee Injuries

Study Results

No Results Posted as of Apr 11, 2019