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

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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