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

Official title

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

Overview

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.

Detailed description

To be successful, an ACL reconstruction requires a strong incorporation of the tendon to the bone within or at the margin of the tunnel, but the tunnel itself is at risk of widening, therefore compromising the tendon attachment. A composite of harvested healthy autologous bone fragments from the tunnel and autologous thrombin and fibrin, generated from the patient's PrP could be used at the interface between tunnel and ACL graft at the tibia and femur to reduce frequency of tunnel widening and therefore improve graft-bone-integration.

The study seeks primarily to determine less tibial tunnel widening when a bone/PrP-composite is applied directly in the tibial tunnel compared to the same surgery without using the composite, measured with CT and MRI.

Secondary study objectives are to evaluate femoral tunnel widening, tibial and femoral graft incorporation, graft maturation and knee function (clinical, functional, patient reported) over the course of 24 months follow-up and to evaluate occurrence of procedure- and product-related adverse events and complications.

This is a prospective, single-center, single-blinded, 2-arm-parallel, randomized, controlled study with 24 months follow-up. Participants will be recruited from the Knee Surgery department at Schulthess Klinik when scheduled for ACL reconstruction. The study sample comprises 107 patients, allocated 1:1 on experimental and control arm. Outcome measures are taken at 0, 6, 12, and 24 months. The total study duration is 48 months. The study duration per patient is 24 months.

Interventions

• Procedure ACL 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.
• Procedure ACL 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

Primary outcome measures

• Tibial tunnel diameter change [Time frame: 10 to 14 months post-surgery]
• Tibial tunnel volume change [Time frame: 10 to 14 months post-surgery]

Secondary outcome measures (6)

• Femoral tunnel diameter change [Time frame: 10 to 14 months post-surgery]
• Femoral tunnel volume change [Time frame: 10 to 14 months post-surgery]
• Graft maturity_subj [Time frame: 10 to 14 months post-surgery]
• Graft maturity_obj [Time frame: 10 to 14 months post-surgery]
• Graft integration [Time frame: 10 to 14 months post-surgery]
• Bone healing and integration [Time frame: 10 to 14 months post-surgery]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• Schulthess Klinik — Zurich

Identifiers

NCT: NCT05953051 · UE-0073 · 2022-00168

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗