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

Primary Purpose

Knee Pain, Knee Injuries

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
platelet rich plasma
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Pain focused on measuring PRP, regeneration, ultrasound

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rehab Abdelaal ELnemr

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRP group

control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
meniscal healing process
by ultrasonography

Secondary Outcome Measures

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
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
meniscal healing
by ultrasonography

Full Information

First Posted
April 6, 2019
Last Updated
April 9, 2019
Sponsor
Alexandria University
Collaborators
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT03910036
Brief Title
Effect of PRP Injection After Arthroscopic Meniscal Repair in the Healing Process
Acronym
KneePRP
Official Title
Does Post-Operative Intra-Articular Platelet Rich Plasma Injection Improve Meniscal Repair Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
December 5, 2017 (Actual)
Study Completion Date
March 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
Collaborators
University of Alexandria

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain, Knee Injuries
Keywords
PRP, regeneration, ultrasound

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
the outcome measures assessors were blinded to subjects who receive injection and those who didn't
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
15 patients to constitute the PRP-group was injected intra-articularly with about 5 ml of PRP in the operated knee joint
Arm Title
control group
Arm Type
No Intervention
Arm Description
The other fifteen patients were not injected and constituted control group.
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
knee Pain
Description
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
Time Frame
3 months
Title
Knee function
Description
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
Time Frame
3 months
Title
meniscal healing process
Description
by ultrasonography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
knee pain
Description
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
Time Frame
6 months
Title
knee function
Description
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
Time Frame
6 months
Title
meniscal healing
Description
by ultrasonography
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab A ELnemr, lecturer
Organizational Affiliation
Alexandria University, faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Abdelaal ELnemr
City
Alexandria
ZIP/Postal Code
123456
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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