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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorSchulthess Klinik

About this trial

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 criteria

Qualifiers

Age 18-50 years

Primary ACL rupture

Time from injury to surgery: 4 weeks to 6 months

Single ACL rupture (isolated rupture)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ACL reconstruction with bone/PrP-composite
  • ACL reconstruction (Standard)

Treatment groups

107 Participants
are divided into 2 treatment groups

Sponsors and collaborators