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Compares treatment options for Anterior Cruciate Ligament Tear
Official title Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
ClinicalTrials.gov ID: NCT05953051
What this study is testing
- What it's testing
- 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)?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.