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Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction

Primary Purpose

Sports Injury

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Platelet-Rich Plasma
Sponsored by
Beijing Tsinghua Chang Gung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sports Injury focused on measuring Anterior Cruciate Ligament Tear, platelet-rich plasma

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of knee injury
  • History of knee instability
  • Anterior drawer test (+), or / and Lachman test (+)
  • The tear of anterior cruciate ligament was confirmed by MRI

Exclusion Criteria:

  • The injury of other ligaments of knee joint, such as complex posterior cruciate ligament injury, lateral collateral ligament injury and medial collateral ligament injury above III degree
  • Patients with meniscus removed
  • Patients with moderate to severe articular cartilage injury
  • Patients with complex nerves and blood vessels injury
  • Patients with compound intra - and periarticular fractures of the knee
  • Patients with intra or periarticular fractures of the knee
  • Patients with contralateral knee instability
  • Patients with severe cardiovascular and cerebrovascular diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Platelet-Rich Plasma

    control group

    Arm Description

    Four semitendinosus tendons and gracilis tendons are prepared. 4 ml platelet-rich plasma is completely absorbed by a gelatin sponge and fixed in the center of the four tendons. 4-0 absorbable line is used for fixation.Then we use conventional surgical techniques to reconstruct the ACL.

    We performed conventional surgical techniques to reconstruction without using platelet-rich plasma.

    Outcomes

    Primary Outcome Measures

    tendon bone healing and ligament maturing
    The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm). The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
    tendon bone healing and ligament maturing
    The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm). The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
    proprioception and Knee joint function
    KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
    proprioception and Knee joint function
    KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
    proprioception and Knee joint function
    KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
    Knee pain
    Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
    Knee pain
    Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
    Knee pain
    Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 23, 2020
    Last Updated
    December 2, 2020
    Sponsor
    Beijing Tsinghua Chang Gung Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04659447
    Brief Title
    Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction
    Official Title
    Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    November 9, 2021 (Anticipated)
    Study Completion Date
    November 9, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Tsinghua Chang Gung Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Anterior cruciate ligament (ACL) injury is a common knee injury, which seriously affects the living ability and sport level of the injured. ACL reconstruction is the main method to treat ACL injury. Due to the reconstructive ligament needs a tendon bone healing and ligament maturation, therefore, in the ACL anatomical study, reconstruction surgery and reconstruction materials under the condition of constant progress, how to improve the ACL reconstruction of tendon bone healing and shorten the time of the ligament mature, improve the clinical effect of ACL reconstruction, has become the focus in the ACL reconstruction. Autologous platelet-rich plasma (PRP) is full of growth factors and bioactive factors, which has the function of promoting tissue healing, anti-inflammatory and analgesic effects. At the same time of anterior cruciate ligament reconstruction, using autologous PRP in the bone channel might promote tendon bone healing and ligament maturing after ACL reconstruction, promote the recovery of proprioception, prevent bone channel expanding, shorten the postoperative recovery time, speed up the patients recovery exercise ability, improve the clinical effect of ACL reconstruction. In this study, patients with ACL injuries were randomly divided into two groups: one group underwent ACL anatomical reconstruction, and the other group underwent ACL anatomical reconstruction with PRP. Various clinical scores, KT-2000, Biodex and imaging tests were used to evaluate the differences in the clinical effects of the two surgical methods in terms of postoperative pain, joint swelling, knee function, joint stability, muscle strength recovery, bone channel expanding, ligament vasinization, and ligament maturation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sports Injury
    Keywords
    Anterior Cruciate Ligament Tear, platelet-rich plasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet-Rich Plasma
    Arm Type
    Experimental
    Arm Description
    Four semitendinosus tendons and gracilis tendons are prepared. 4 ml platelet-rich plasma is completely absorbed by a gelatin sponge and fixed in the center of the four tendons. 4-0 absorbable line is used for fixation.Then we use conventional surgical techniques to reconstruct the ACL.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    We performed conventional surgical techniques to reconstruction without using platelet-rich plasma.
    Intervention Type
    Drug
    Intervention Name(s)
    Platelet-Rich Plasma
    Intervention Description
    36 ml of peripheral blood is extracted from patients, and 4 ml of 3.8% sodium citrate is added for anticoagulation. After centrifugation for 2 times, 4 ml platelet-rich plasma will be prepared.Four semitendinosus tendons and gracilis tendons are prepared.
    Primary Outcome Measure Information:
    Title
    tendon bone healing and ligament maturing
    Description
    The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm). The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
    Time Frame
    CT and MRI were performed on the fourth day after operation
    Title
    tendon bone healing and ligament maturing
    Description
    The diameter of bone canal was evaluated by CT, it is measured in millimeters (mm). The tendon bone healing and ligament maturing was evaluated by MRI. According to the same level of anterior cruciate ligament, femoral canal, posterior cruciate ligament, background noise, with the diameter of 3.3 mm as the center, the lowest signal value point was measured, and the final point was compared to obtain the Signal-Noise Ratio.
    Time Frame
    CT and MRI were performed on one year after operation
    Title
    proprioception and Knee joint function
    Description
    KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
    Time Frame
    3 months after the operation
    Title
    proprioception and Knee joint function
    Description
    KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
    Time Frame
    6 months after the operation
    Title
    proprioception and Knee joint function
    Description
    KT-2000, it was used to assess the stability of the tibia and the results were expressed in millimeters. Biodex, it is used to assess the strength and function of joints. The contralateral knee joint was taken as the reference. The percentage of strength between the affected knee joint and the contralateral knee joint was obtained
    Time Frame
    1 year after the operation
    Title
    Knee pain
    Description
    Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
    Time Frame
    3 months after the operation
    Title
    Knee pain
    Description
    Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
    Time Frame
    6 months after the operation
    Title
    Knee pain
    Description
    Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
    Time Frame
    1 year after the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of knee injury History of knee instability Anterior drawer test (+), or / and Lachman test (+) The tear of anterior cruciate ligament was confirmed by MRI Exclusion Criteria: The injury of other ligaments of knee joint, such as complex posterior cruciate ligament injury, lateral collateral ligament injury and medial collateral ligament injury above III degree Patients with meniscus removed Patients with moderate to severe articular cartilage injury Patients with complex nerves and blood vessels injury Patients with compound intra - and periarticular fractures of the knee Patients with intra or periarticular fractures of the knee Patients with contralateral knee instability Patients with severe cardiovascular and cerebrovascular diseases

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35103026
    Citation
    Gong H, Huang B, Zheng Z, Fu L, Chen L. Clinical Use of Platelet-Rich Plasma to Promote Tendon-Bone Healing and Graft Maturation in Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Study. Indian J Orthop. 2022 Jan 27;56(5):805-811. doi: 10.1007/s43465-021-00533-z. eCollection 2022 May.
    Results Reference
    derived

    Learn more about this trial

    Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction

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