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

Kaohsiung Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: ACL; PRP; Hyaluronic Acid

Treatments: Combination Product: RegenLab PRP; Combination Product: hyaluronic acid; Other: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04586361

200527-2

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups, including a placebo group

Experimental group 1

Experimental group

Description:

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

Treatment:

Combination Product: RegenLab PRP

Experimental group 2

Experimental group

Description:

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

Treatment:

Combination Product: hyaluronic acid

Experimental group 3

Placebo Comparator group

Description:

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

Treatment:

Other: normal saline