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Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191732
Recruitment Status : Completed
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:

Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.

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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Combination Product: Platelet-Rich Plasma; Bone marrow concentrate Not Applicable

Detailed Description:

Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. According to literature, there are 100,000- 200,000 ACL tear case annually in US. The patients with ACL tear will sustain with joint pain, muscle weakness, giving way sensation, other knee ligaments or meniscus injury, and consequent osteoarthritis change. However, the ruptured ACL cannot heal by itself due to limited vascularity supply, intraarticular inflammatory factors which inhibit the ACL cells migration and proliferation. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Therapeutic Effect of Autologous Platelet-Rich Plasma Versus Bone Marrow Concentrate in Anterior Cruciate Ligament Reconstruction - A Prospective, Double-Blind Randomized Controlled Study
Actual Study Start Date : August 3, 2018
Actual Primary Completion Date : July 4, 2020
Actual Study Completion Date : July 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRP augmentation ACL reconstruction group
Platelet-rich plasma (PRP) (Dosage form: APA-15)
Combination Product: Platelet-Rich Plasma; Bone marrow concentrate
Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)

Experimental: PRP+BMC augmentation ACL reconstruction group
Bone marrow concentrate (BMC) (Dosage form: APA-15Q)
Combination Product: Platelet-Rich Plasma; Bone marrow concentrate
Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)

No Intervention: Traditional ACL reconstruction group
No intervention



Primary Outcome Measures :
  1. X-ray [ Time Frame: preoperative ]
    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

  2. X-ray [ Time Frame: 3 months after ACL reconstruction. ]
    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

  3. X-ray [ Time Frame: 6 months after ACL reconstruction. ]
    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

  4. X-ray [ Time Frame: 12 months after ACL reconstruction. ]
    X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.

  5. MRI [ Time Frame: preoperative ]
    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

  6. MRI of operated knee [ Time Frame: 3 months after ACL reconstruction. ]
    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

  7. MRI of operated knee [ Time Frame: 6 months after ACL reconstruction. ]
    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

  8. MRI of operated knee [ Time Frame: 12 months after ACL reconstruction. ]
    MRI to evaluate the joint space, graft to bone healing status and graft incorporation.

  9. Lysholm score [ Time Frame: preoperative ]
    Lysholm score to evaluate the knee function recovery

  10. Lysholm score [ Time Frame: 3 months after ACL reconstruction. ]
    Lysholm score to evaluate the knee function recovery

  11. Lysholm score [ Time Frame: 6 months after ACL reconstruction. ]
    Lysholm score to evaluate the knee function recovery

  12. Lysholm score [ Time Frame: 12 months after ACL reconstruction. ]
    Lysholm score to evaluate the knee function recovery

  13. IKDC 2000 [ Time Frame: preoperative ]
    IKDC 2000 to evaluate the knee function recovery

  14. IKDC 2000 [ Time Frame: 3 months after ACL reconstruction. ]
    IKDC 2000 to evaluate the knee function recovery

  15. IKDC 2000 [ Time Frame: 6 months after ACL reconstruction. ]
    IKDC 2000 to evaluate the knee function recovery

  16. IKDC 2000 [ Time Frame: 12 months after ACL reconstruction. ]
    IKDC 2000 to evaluate the knee function recovery

  17. Muscle power (N.m/kg) [ Time Frame: preoperative ]
    muscle power test by Biodex System 3 Pro

  18. Muscle power (N.m/kg) [ Time Frame: 3 months after ACL reconstruction. ]
    muscle power test by Biodex System 3 Pro

  19. Muscle power (N.m/kg) [ Time Frame: 6 months after ACL reconstruction. ]
    muscle power test by Biodex System 3 Pro

  20. Muscle power (N.m/kg) [ Time Frame: 12 months after ACL reconstruction. ]
    muscle power test by Biodex System 3 Pro

  21. Proprioception (degree) [ Time Frame: preoperative ]
    Proprioception test by Biodex System 3 Pro

  22. Proprioception (degree) [ Time Frame: 3 months after ACL reconstruction. ]
    Proprioception test by Biodex System 3 Pro

  23. Proprioception (degree) [ Time Frame: 6 months after ACL reconstruction. ]
    Proprioception test by Biodex System 3 Pro

  24. Proprioception (degree) [ Time Frame: 12 months after ACL reconstruction. ]
    Proprioception test by Biodex System 3 Pro



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≧ 20 year-old
  • the patient has been confirmed ACL rupture and the reconstruction is indicated
  • sign IRB and operation consent

Exclusion Criteria:

  • combined other ligament or extremities injury
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191732


Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Ministry of Health and Welfare, Taiwan
Investigators
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Principal Investigator: Pei-Hsi Chou, PhD Kaohsiung Medical University Chung-Ho Memorial Hospital
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT05191732    
Other Study ID Numbers: KMUHIRB-F(I)-20170122
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Anterior cruciate ligament reconstruction
Platelet-Rich Plasma
Bone marrow concentrate
Hamstring tendon