Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction
NCT ID: NCT04659447
Last Updated: 2020-12-09
Study Results
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Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2016-07-01
2021-11-09
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Platelet-Rich Plasma
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.
control group
We performed conventional surgical techniques to reconstruction without using platelet-rich plasma.
No interventions assigned to this group
Interventions
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Platelet-Rich Plasma
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.
Eligibility Criteria
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Inclusion Criteria
* History of knee instability
* Anterior drawer test (+), or / and Lachman test (+)
* The tear of anterior cruciate ligament was confirmed by MRI
Exclusion Criteria
* 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
15 Years
50 Years
ALL
No
Sponsors
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Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
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References
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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.
Other Identifiers
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12017B3003
Identifier Type: -
Identifier Source: org_study_id