NCT04659447

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

Status unknown Phase 1 Last updated 9 December 2020

What this trial tests

Phase 1 trial testing Platelet-Rich Plasma in Sports Injury in 60 participants. Status unknown.

Timeline

1 July 2016

Primary endpoint
9 November 2021

9 November 2021

Quick facts

Lead sponsor	Beijing Tsinghua Chang Gung Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 July 2016
Primary completion	9 November 2021
Estimated completion	9 November 2021

Drugs / interventions tested

• Platelet-Rich Plasma

Conditions studied

• Sports Injury — all drugs for Sports Injury →

Sponsor

Beijing Tsinghua Chang Gung Hospital

Who can join

Adults 15 to 50, any sex, with Sports Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Strategies for promoting tendon-bone healing: Current status and prospects.
   Yang C, Teng Y, Geng B, Xiao H, et al · · 2023 · cited 35× · PMID 36777256 · DOI 10.3389/fbioe.2023.1118468
2. Clinical Use of Platelet-Rich Plasma to Promote Tendon-Bone Healing and Graft Maturation in Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Study.
   Gong H, Huang B, Zheng Z, Fu L, et al · · 2022 · cited 18× · PMID 35103026 · DOI 10.1007/s43465-021-00533-z
3. Strategies to promote tendon-bone healing after anterior cruciate ligament reconstruction: Present and future.
   Tian B, Zhang M, Kang X. · · 2023 · cited 16× · PMID 36994361 · DOI 10.3389/fbioe.2023.1104214
4. Platelet-Rich Plasma in Anterior Cruciate Ligament Reconstruction: An Updated Systematic Review and Meta-Analysis of Clinical and Radiological Outcomes.
   Abdallah A, Assaf G, Chahine C, Orm GA, et al · · 2026 · PMID 41976826 · DOI 10.3390/jcm15072526