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

ACL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586361
• Other study ID #: 200527-2
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: October 2020
• Source: Kaohsiung Veterans General Hospital.
• Contact: Yi Ping Wei, MD
• Phone: +886-7-342-2121
• Email: xgoznas22[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACL
• Anterior Cruciate Ligament Injuries
• Hyaluronic Acid
• PRP

Intervention

Combination Product:
• 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.
• 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.

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung	???

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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