RecruitingNot ApplicableNCT05953051

Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique

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

Sponsor

Schulthess Klinik

Enrollment

107 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Anterior Cruciate Ligament tear

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria6

Age 18-50 years
Primary ACL rupture
Time from injury to surgery: 4 weeks to 6 months
Single ACL rupture (isolated rupture)
ACL surgery with one of the participating senior surgeons
Informed Consent as documented by signature

Exclusion Criteria9

Concomitant ligamentous instability/rupture
Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact)
Requirement for cartilage invasive treatment (debridement accepted)
Osteoarthritis at index knee joint
Leg axis deviation over 3° valgus or 4° varus
Claustrophobia (contra-indication for the MRI)
Women who are pregnant or breast feeding or intention to become pregnant during the study
Known or suspected non-compliance, drug or alcohol abuse
Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.

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Interventions

PROCEDUREACL reconstruction with bone/PrP-composite

During standard ACL reconstruction, the drilled bone debris is collected in a sterile filtered chamber. Then the bone debris is mixed with PrP. After fixation of the graft the composite is inserted into the drilled tunnel at the interface between tendon to bone. The intraarticular aperture sites are sealed by use of fibrin that is previously gathered out of the PrP as well.

PROCEDUREACL reconstruction (Standard)

Standard ACL reconstruction with Semitendinosus alone or plus gracilis, femoral fixation via extracortical fixation by adjustable loop device, tibial fixation via a bio-interference screw or adjustable device