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

NCT03910036 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 0303544
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Pain; Knee Injuries

Keywords

PRP; regeneration; ultrasound

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• meniscal healing process

  by ultrasonography

  3 months

Secondary Outcomes (3)

• knee pain

  6 months

• knee function

  6 months

• meniscal healing

  6 months

Study Arms (2)

PRP group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

platelet rich plasma BIOLOGICAL

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.

PRP group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-55 years
• Complete meniscal tear in red-white zone done repaired
• Surgery was done by by a single surgeon

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• University of Alexandria: collaborator

Study Sites (1)

Rehab Abdelaal ELnemr

Alexandria, 123456, Egypt

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Rehab A ELnemr, lecturer

  Alexandria University, faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcome measures assessors were blinded to subjects who receive injection and those who didn't
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 10, 2019
• Study Start: March 3, 2017
• Primary Completion: December 5, 2017
• Study Completion: March 20, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)