NCT04586361

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

September 13, 2020

Last Update Submit

October 7, 2020

Conditions

PRPACLHyaluronic Acid

Keywords

PRP; ACL reconstruction

Outcome Measures

Primary Outcomes (4)

  • 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

    postoperative 1 month

  • 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

    postoperative 3 months

  • 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

    postoperative 12 months

  • 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

    postoperative 3 month

Study Arms (3)

Experimental group 1

EXPERIMENTAL

Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction.

Combination Product: RegenLab PRP

Experimental group 2

EXPERIMENTAL

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

Combination Product: hyaluronic acid

Experimental group 3

PLACEBO COMPARATOR

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

Other: normal saline

Interventions

RegenLab PRPCOMBINATION_PRODUCT

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 group 1
hyaluronic acidCOMBINATION_PRODUCT

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
Experimental group 2
normal salineOTHER

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

Experimental group 3

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, 813, Taiwan

RECRUITING

MeSH Terms

Interventions

Hyaluronic AcidSaline Solution

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yi Ping Wei, MD

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ping Wei, MD

CONTACT

+886-7-342-2121xgoznas22@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief resident, Orthopedics department, Kaohsiung Veterans General Hospital; Principal Investigator

Study Record Dates

First Submitted

September 13, 2020

First Posted

October 14, 2020

Study Start

October 15, 2020

Primary Completion

September 15, 2021

Study Completion

September 15, 2022

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

TW(1)