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

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ClinicalTrials.gov Identifier: NCT03910036
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
University of Alexandria
Information provided by (Responsible Party):
Rehab Abdelaal ELnemr, Alexandria University

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : March 3, 2017
Actual Primary Completion Date : December 5, 2017
Actual Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. knee Pain [ Time Frame: 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

  2. Knee function [ Time Frame: 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

  3. meniscal healing process [ Time Frame: 3 months ]
    by ultrasonography


Secondary Outcome Measures :
  1. knee pain [ Time Frame: 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

  2. knee function [ Time Frame: 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

  3. meniscal healing [ Time Frame: 6 months ]
    by ultrasonography



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910036


Locations
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Egypt
Rehab Abdelaal ELnemr
Alexandria, Egypt, 123456
Sponsors and Collaborators
Alexandria University
University of Alexandria
Investigators
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Principal Investigator: Rehab A ELnemr, lecturer Alexandria University, faculty of medicine
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Responsible Party: Rehab Abdelaal ELnemr, lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT03910036    
Other Study ID Numbers: 0303544
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Rehab Abdelaal ELnemr, Alexandria University:
PRP
regeneration
ultrasound
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries