跳至主要内容
临床试验/NCT04586361
NCT04586361Unknown4 期

Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear

Kaohsiung Veterans General Hospital.2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
4 期
入组人数
150
试验地点
2
主要终点
150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed

研究概览

简要总结

Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee.

Methods:

The study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. We divided the patients in three groups, and we treated the group A with perioperative injection of HHA, group B with perioperative HHA+PRP, group C with perioperative normal saline.

Follow-up:

Every 1,3,and 12months, we recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • receiving unilateral ACL reconstruction in our hospital
  • postoperative follow-up over 3 month

排除标准

  • postoperative follow-up less than 3 month
  • possible pregnency
  • with coagulation disease
  • NSAIDs intake during study period

结局指标

主要结局

150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed

时间窗: postoperative 3 month

anterior cruciate ligament was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist

150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test

时间窗: postoperative 12 months

the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

次要结局

未报告次要终点

研究者

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

Yi Ping Wei

Chief resident, Orthopedics department, Kaohsiung Veterans General Hospital; Principal Investigator

Kaohsiung Veterans General Hospital.

研究点 (2)

Loading locations...

相似试验