Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction
NCT ID: NCT05191732
Last Updated: 2022-01-13
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-08-03
2020-07-04
Brief Summary
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Platelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study.
However, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.
Aim of this study： To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
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Detailed Description
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Platelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. The PRP has been applied in treating tendinitis, osteoarthritis, cartilage injury, and bone nonunion. Bone marrow contains lots of stem cell and progenitor cells with capability of self-renewal and multi-differentiation. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study. The bone marrow concentrate (BMC) can be isolated from the bone marrow through the centrifuge procedure at one time which contains multiple stem cells. The bone marrow can regenerate itself around 1 week.
In recent years, many authors uses the combination of RPP and BMC to treat injured tissue. However, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.
The purpose of this study is to investigate the clinical outcome of autologous PRP, and combined BMC+PRP in tendon graft augmentation in the ACL reconstruction surgery with functional score and MRI evaluation. Investigators will analyze the therapeutic effect using one-way ANOVA. To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PRP augmentation ACL reconstruction group
Platelet-rich plasma (PRP) (Dosage form: APA-15)
Platelet-Rich Plasma; Bone marrow concentrate
Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)
PRP+BMC augmentation ACL reconstruction group
Bone marrow concentrate (BMC) (Dosage form: APA-15Q)
Platelet-Rich Plasma; Bone marrow concentrate
Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)
Traditional ACL reconstruction group
No intervention
No interventions assigned to this group
Interventions
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Platelet-Rich Plasma; Bone marrow concentrate
Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)
Eligibility Criteria
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Inclusion Criteria
* the patient has been confirmed ACL rupture and the reconstruction is indicated
* sign IRB and operation consent
Exclusion Criteria
* prior the same knee surgery
* open wound or operation history at knee joint
* Severe knee osteoarthritis
* history of multiple joint arthritis or rheumatoid arthritis
* Systemic diseases (infections, malignancies, immunodepression)
* patients with bleeding tendency, anticoagulant or antiaggregant therapies
* patients with Hb values \< 11 g/dl and/or platelet values \< 150,000/mm
* refuse to sign Informed Consent Form and operation consent
20 Years
ALL
No
Sponsors
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Ministry of Health and Welfare, Taiwan
OTHER_GOV
Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Pei-Hsi Chou, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University Chung-Ho Memorial Hospital
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Other Identifiers
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KMUHIRB-F(I)-20170122
Identifier Type: -
Identifier Source: org_study_id
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