Clinical trial NCT04659447: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sports Injury
Keywords: Anterior Cruciate Ligament Tear
platelet-rich plasma
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: tendon bone healing and ligament maturing
timeFrame: CT and MRI were performed on the fourth day after operation
measure: tendon bone healing and ligament maturing
timeFrame: CT and MRI were performed on one year after operation
measure: proprioception and Knee joint function
timeFrame: 3 months after the operation
measure: proprioception and Knee joint function
timeFrame: 6 months after the operation
measure: proprioception and Knee joint function
timeFrame: 1 year after the operation
measure: Knee pain
timeFrame: 3 months after the operation
measure: Knee pain
timeFrame: 6 months after the operation
measure: Knee pain
timeFrame: 1 year after the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.