Clinical trial NCT03910036: Effect of PRP Injection After Arthroscopic Meniscal Repair in the Healing Process
Official title: Does Post-Operative Intra-Articular Platelet Rich Plasma Injection Improve Meniscal Repair Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Pain
Knee Injuries
Keywords: PRP
regeneration
ultrasound
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: University of Alexandria
First posted: 2019-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: knee Pain
timeFrame: 3 months
measure: Knee function
timeFrame: 3 months
measure: meniscal healing process
timeFrame: 3 months
Secondary outcomes:
measure: knee pain
timeFrame: 6 months
measure: knee function
timeFrame: 6 months
measure: meniscal healing
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Rehab Abdelaal ELnemr
Study officials:
affiliation: Alexandria University, faculty of medicine
name: Rehab A ELnemr, lecturer
role: PRINCIPAL_INVESTIGATOR
References: