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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

Tracking Information
First Submitted Date  ICMJE April 6, 2019
First Posted Date  ICMJE April 10, 2019
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE March 3, 2017
Actual Primary Completion Date December 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • 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
  • 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
  • meniscal healing process [ Time Frame: 3 months ]
    by ultrasonography
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • knee Pain [ Time Frame: 3 months ]
    VAS score
  • Knee function [ Time Frame: 3 months ]
    KOOS assessment score
  • meniscal healing process [ Time Frame: 3 months ]
    by ultrasonography
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • 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
  • 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
  • meniscal healing [ Time Frame: 6 months ]
    by ultrasonography
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • knee pain [ Time Frame: 6 months ]
    VAS score
  • knee function [ Time Frame: 6 months ]
    KOOS score
  • meniscal healing [ Time Frame: 6 months ]
    by ultrasonography
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of PRP Injection After Arthroscopic Meniscal Repair in the Healing Process
Official Title  ICMJE Does Post-Operative Intra-Articular Platelet Rich Plasma Injection Improve Meniscal Repair Outcomes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Knee Pain
  • Knee Injuries
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Biological: platelet rich plasma
  • No Intervention: control group
    The other fifteen patients were not injected and constituted control group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2019)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 20, 2018
Actual Primary Completion Date December 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03910036
Other Study ID Numbers  ICMJE 0303544
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rehab Abdelaal ELnemr, Alexandria University
Study Sponsor  ICMJE Alexandria University
Collaborators  ICMJE University of Alexandria
Investigators  ICMJE
Principal Investigator: Rehab A ELnemr, lecturer Alexandria University, faculty of medicine
PRS Account Alexandria University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP