Brief Title
Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
Official Title
Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
Brief Summary
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Condition
PRP
Intervention
RegenLab PRP
Study Arms / Comparison Groups
Experimental group 1
Description: Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Combination Product
Estimated Enrollment
150
Start Date
October 15, 2020
Completion Date
September 15, 2022
Primary Completion Date
September 15, 2021
Eligibility Criteria
Inclusion Criteria:
- receiving unilateral ACL reconstruction in our hospital
- postoperative follow-up over 3 month
Exclusion Criteria:
- postoperative follow-up less than 3 month
- possible pregnency
- with coagulation disease
- NSAIDs intake during study period
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Yi Ping Wei, MD, +886-7-342-2121, [email protected]
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT04586361
Organization ID
200527-2
Responsible Party
Principal Investigator
Study Sponsor
Kaohsiung Veterans General Hospital.
Study Sponsor
Yi Ping Wei, MD, Principal Investigator, Kaohsiung Veterans General Hospital.
Verification Date
October 2020