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

NCT ID: NCT04586361

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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PRP ACL Hyaluronic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group 1

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

Group Type EXPERIMENTAL

RegenLab PRP

Intervention Type COMBINATION_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 2

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

Group Type EXPERIMENTAL

hyaluronic acid

Intervention Type COMBINATION_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.

Experimental group 3

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

normal saline

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

Intervention Type OTHER

Other Intervention Names

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RegenLab PRP

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Yi Ping Wei

Chief resident, Orthopedics department, Kaohsiung Veterans General Hospital; Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Ping Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi Ping Wei, MD

Role: CONTACT

+886-7-342-2121

Facility Contacts

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Yi Ping Wei, MD

Role: primary

073422121

Other Identifiers

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200527-2

Identifier Type: -

Identifier Source: org_study_id

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