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

Phase 1

• Conditions: Sports Injury
• Interventions: Drug: Platelet-Rich Plasma

• Registration Number: NCT04659447
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2020-11-23
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-09
• Last Update Posted: 2020-12-09
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-Rich Plasma	Platelet-Rich Plasma	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.

Primary Outcome Measures

Name	Time	Method
Knee pain	1 year after the operation	Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
tendon bone healing and ligament maturing	CT and MRI were performed on one year after operation	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	1 year after the operation	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