Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2016
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2021
CompletedDecember 9, 2020
December 1, 2020
5.4 years
November 23, 2020
December 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
CT and MRI were performed on the fourth day after operation
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.
CT and MRI were performed on one year after operation
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
3 months after the operation
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
6 months after the operation
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
1 year after the operation
Knee pain
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
3 months after the operation
Knee pain
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
6 months after the operation
Knee pain
Visual Analog Score for pain, it is used to assess the patient's pain, the full score is 10.
1 year after the operation
Study Arms (2)
Platelet-Rich Plasma
EXPERIMENTALFour 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.
control group
NO INTERVENTIONWe performed conventional surgical techniques to reconstruction without using platelet-rich plasma.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35103026DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2020
First Posted
December 9, 2020
Study Start
July 1, 2016
Primary Completion
November 9, 2021
Study Completion
November 9, 2021
Last Updated
December 9, 2020
Record last verified: 2020-12