A Single-center, Patient-blinded, Randomized, 2-year, Parallel-group, Superiority Study to Compare the Efficacy of Augmented ACL Integration Via Platelet-rich-plasma Enriched Collected Autologous Bone Versus Standard ACL Technique

The purpose of this clinical study is to compare the outcomes of two surgical techniques for reconstruction of the anterior cruciate ligament (ACL) after a single, primary ACL rupture. The main question to be answered is: \- Does less widening of the tibial tunnel occur when a bone/Platelet rich plasma (PrP) composite material is placed directly into the tibial tunnel after fixation of the implant (experimental group) compared to the same surgery without the use of the composite material (control group)? Participants will be randomized into one of the two groups and they will not know which group they belong to. After 12 months they will undergo CT, MRI, medical examination and functional knee testing. They will have a further medical examination and functional knee testing at 24 months. Patient Reported Outcomes will be collected before surgery, 6, 12 and 24 months after surgery.

Full record on ClinicalTrials.gov (NCT ID NCT05953051).

Age range: 18–50 · Sex: All · Healthy volunteers: Requires diagnosis

Phase

Phase None

Study type

Interventional

Allocation

Randomized

Masking

Double-blind

Intervention model

Parallel assignment

Primary purpose

Treatment

Enrollment target

107 participants

Estimated completion

August 2027

1 site currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.