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

Phase 4

• Conditions: Hyaluronic Acid; ACL; PRP
• Interventions: Other: normal saline; Combination Product: hyaluronic acid; Combination Product: RegenLab PRP

• Registration Number: NCT04586361
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-13
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Study Start: 2020-10-15
• Primary Completion: 2021-09-15
• Study Completion: 2022-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 3	normal saline	Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction.
Experimental group 2	hyaluronic acid	Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction.
Experimental group 1	RegenLab PRP	Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, 高雄市, Taiwan