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

Primary Purpose

PRP, ACL, Hyaluronic Acid

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
RegenLab PRP
hyaluronic acid
normal saline
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PRP focused on measuring PRP; ACL reconstruction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kaohsiung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental group 1

Experimental group 2

Experimental group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2020
Last Updated
October 7, 2020
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT04586361
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PRP, ACL, Hyaluronic Acid
Keywords
PRP; ACL reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction.
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction.
Arm Title
Experimental group 3
Arm Type
Placebo Comparator
Arm Description
Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction.
Intervention Type
Combination Product
Intervention Name(s)
RegenLab PRP
Intervention Description
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
Intervention Name(s)
hyaluronic acid
Other Intervention Name(s)
RegenLab PRP
Intervention Description
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
Other
Intervention Name(s)
normal saline
Intervention Description
In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.
Primary Outcome Measure Information:
Title
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Description
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
Time Frame
postoperative 1 month
Title
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Description
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
Time Frame
postoperative 3 months
Title
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Description
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
Time Frame
postoperative 12 months
Title
150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
Description
anterior cruciate ligament was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist
Time Frame
postoperative 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Ping Wei, MD
Phone
+886-7-342-2121
Email
xgoznas22@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Ping Wei, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
State/Province
高雄市
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Ping Wei, MD
Phone
073422121
Email
xgoznas22@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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