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

October 7, 2020 updated by: Yi Ping Wei, Kaohsiung Veterans General Hospital.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • 高雄市
      • Kaohsiung, 高雄市, Taiwan, 813
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group 1
Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction.
Combination product: RegenLab PRP
PRP preparations also improved functional outcome scores compared to hyaluronic acid and placebo in patients affected by knee osteoarthritis (OA). Based on previous studys, we can conclude that the PRP treatment is a safe and efficacious procedure which can provide functional benefit.
Experimental: Experimental group 2
Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction.
Combination product: hyaluronic acid
Few studies investigated the effects of HA+PRP combined treatment for knee osteoarthritis (OA). Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life.
Other Names:
  • RegenLab PRP
Placebo Comparator: Experimental group 3
Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction.
Other: normal saline
In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Time Frame: postoperative 1 month
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
postoperative 1 month
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Time Frame: postoperative 3 months
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
postoperative 3 months
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Time Frame: postoperative 12 months
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
postoperative 12 months
150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
Time Frame: postoperative 3 month
anterior cruciate ligament was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist
postoperative 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Yi Ping Wei, MD, Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2020

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

September 15, 2022

Study Registration Dates

First Submitted

September 13, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200527-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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