Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07819929 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Mid-term Postoperative Clinical Evaluation of Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction Using the Over-The-Top Technique, Fixed With Metal Staples or Soft Anchors.

Study acronym: Metal-free OTT
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Anterior cruciate ligament (ACL) reconstruction is a widely performed procedure aimed at restoring knee stability and enabling return to sports activities. The Over-The-Top (OTT) technique is a well-established option, particularly in complex and revision cases, due to its ability to provide both anteroposterior and rotational stability. Long-term studies have reported favorable clinical outcomes, with low failure rates. Graft fixation is an important technical aspect that may influence postoperative outcomes. Traditionally, the OTT technique has been performed using metal staples, which provide reliable primary fixation but may cause local complications and sometimes require subsequent removal due to pain or discomfort. More recently, suture-based fixation devices, such as Knee FiberTak anchors (Arthrex), have been introduced as a metal-free alternative. These devices allow graft fixation through high-strength sutures, providing stable graft-to-bone contact while minimizing bony invasiveness and hardware prominence. The present study aims to evaluate the clinical, functional, and instrumental outcomes of ACL reconstruction using the OTT technique with graft fixation by suture anchors compared with traditional metal staples. Particular attention will be paid to postoperative knee stability, assessed using validated instruments (KT-1000 and KiRA), as well as failure rates, reoperations, and complications.
Trial Details
NCT Number NCT07819929
Lead Sponsor Stefano Zaffagnini
Conditions
(from sponsor)
ACL Reconstruction, Fixation
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov