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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04586361
Enrollment
150
Registered
2020-10-14
Start date
2020-10-15
Completion date
2022-09-15
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL, Hyaluronic Acid, PRP

Keywords

PRP; ACL reconstruction

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.

Interventions

COMBINATION_PRODUCTRegenLab 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.

COMBINATION_PRODUCThyaluronic 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.

OTHERnormal saline

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

Sponsors

Kaohsiung Veterans General Hospital.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessedpostoperative 3 monthanterior 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 testpostoperative 1 monththe investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist

Countries

Taiwan

Contacts

Primary ContactYi Ping Wei, MD
xgoznas22@gmail.com+886-7-342-2121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026