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临床试验/NCT03910036
NCT03910036已完成4 期

Does Post-Operative Intra-Articular Platelet Rich Plasma Injection Improve Meniscal Repair Outcomes

Alexandria University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年3月3日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
2
主要终点
knee Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

the outcome measures assessors were blinded to subjects who receive injection and those who didn't

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: platelet rich plasma (Biological)

control group

No Intervention

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

结局指标

主要结局

knee Pain

时间窗: 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

时间窗: 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

时间窗: 3 months

by ultrasonography

次要结局

  • knee pain(6 months)
  • knee function(6 months)
  • meniscal healing(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehab Abdelaal ELnemr

lecturer

Alexandria University

研究点 (2)

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