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Completed

NCT Number: NCT05191732

Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-Rich Plasma; Bone marrow concentrate

Combination Product

Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Ministry of Health and Welfare, Taiwan

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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