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Status unknownNCT04586361Updated Oct 14, 2020

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

A Phase 4 interventional study of RegenLab PRP and hyaluronic acid in PRP, ACL and Hyaluronic Acid, sponsored by Kaohsiung Veterans General Hospital.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Kaohsiung Veterans General Hospital. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • PRP
  • ACL
  • Hyaluronic Acid

Keywords

  • PRP; ACL reconstruction
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 163 are open to participants now.

This study's planned enrollment of 150 is above the median of 56 across 372 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • postoperative follow-up less than 3 month
  • possible pregnency
  • with coagulation disease
  • NSAIDs intake during study period
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • Experimental
    Experimental group 2

    Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction.

    Combination Product: hyaluronic acid

  • Placebo comparator
    Experimental group 3

    Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction.

    Other: normal saline

Interventions

  • Combination productRegenLab 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.

  • Combination producthyaluronic 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.

    Also known as: RegenLab PRP

  • Othernormal saline

    In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.

06

What researchers measure

Primary outcomes

  1. 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test

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

    Time frame: postoperative 1 month

  2. 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test

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

    Time frame: postoperative 3 months

  3. 150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test

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

    Time frame: postoperative 12 months

  4. 150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed

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

    Time frame: postoperative 3 month

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Veterans General Hospital
    Kaohsiung, 高雄市 813, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04586361
Lead sponsor
Kaohsiung Veterans General Hospital.
Responsible party
Yi Ping Wei (Chief resident, Orthopedics department, Kaohsiung Veterans General Hospital; Principal Investigator, Kaohsiung Veterans General Hospital.) — Principal investigator
First posted
Oct 14, 2020
Start date
Oct 15, 2020 (estimated)
Primary completion
Sep 15, 2021 (estimated)
Completion
Sep 15, 2022 (estimated)
Last update
Oct 14, 2020

Study contacts

Yi Ping Wei, MD
Contact
xgoznas22@gmail.com
+886-7-342-2121
Yi Ping Wei, MD
principal investigator · Kaohsiung Veterans General Hospital.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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