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
About this trial
This is an interventional treatment trial for Sports Injury focused on measuring Anterior Cruciate Ligament Tear, platelet-rich plasma
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
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
NCT ID
NCT04659447
First Posted
November 23, 2020
Last Updated
December 2, 2020
Sponsor
Beijing Tsinghua Chang Gung Hospital
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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