Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
NCT ID: NCT04586361
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2020-10-15
2022-09-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group 1
Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction.
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.
Experimental group 2
Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction.
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.
Experimental group 3
Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction.
normal saline
In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.
Interventions
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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.
normal saline
In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* postoperative follow-up over 3 month
Exclusion Criteria
* possible pregnency
* with coagulation disease
* NSAIDs intake during study period
20 Years
ALL
Yes
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Yi Ping Wei
Chief resident, Orthopedics department, Kaohsiung Veterans General Hospital; Principal Investigator
Principal Investigators
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Yi Ping Wei, MD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Veterans General Hospital.
Locations
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Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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200527-2
Identifier Type: -
Identifier Source: org_study_id
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