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.

NCT07819929 | Not Yet Recruiting DMC

• 1 other identifier: Metal-free OTT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Reconstruction; Fixation

Outcome Measures

Primary Outcomes (1)

• KT-1000

  The KT-1000 is a clinical-instrumental test widely used for the standardized assessment of patients undergoing anterior cruciate ligament (ACL) reconstruction. It provides an objective measurement of anterior-posterior knee laxity and is extensively used in both clinical practice and scientific research. The assessment is performed with the patient in a supine position, with the knee flexed to approximately 30° and supported on a dedicated device. The examiner applies a standardized anterior load to the tibia while stabilizing the femur, and the resulting anterior-posterior displacement is recorded by sensors positioned in contact with the patella and tibial tuberosity. The measurement does not have a predefined minimum or maximum value. Lower values indicate less anterior laxity and therefore better knee stability, whereas higher values indicate greater anterior laxity and worse knee stability.

  At least 24 months

Secondary Outcomes (8)

• KiRA

  At least 24 months

• IKDC standard evaluation form

  At least 24 months

• Lysholm Knee Score

  At least 24 months

• VAS

  At least 24 months

• SF-12 (Short Form-12 Health Survey)

  At least 24 months

Study Arms (2)

Metal staples

ACTIVE COMPARATOR

Procedure: ACL reconstruction using the Over-The-Top technique

Soft anchors

EXPERIMENTAL

Procedure: ACL reconstruction using the Over-The-Top technique

Interventions

ACL reconstruction using the Over-The-Top technique PROCEDURE

The procedure involves ACL reconstruction using the Over-The-Top technique, with the graft positioned over the lateral femoral condyle to provide anteroposterior and rotational stability. The graft is secured using either metal staples or suture anchors, according to the assigned fixation technique.

Metal staples; Soft anchors

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of either sex, aged between 18 and 50 years at the time of surgery;
• Patients with an isolated anterior cruciate ligament (ACL) injury, with or without associated meniscal lesions, scheduled for ACL reconstruction and meniscal treatment; .3 Patients whose contralateral knee has never undergone meniscectomy, ligament reconstruction, unicompartmental knee arthroplasty, or total knee arthroplasty;
• \. Patients who have signed the informed consent form.

You may not qualify if:

• Patients with associated injury of the medial collateral ligament (MCL), lateral collateral ligament (LCL), posterolateral corner (PLC), or posterior cruciate ligament (PCL);
• Patients with complete meniscal root tears, complete radial tears, or lateral meniscus oblique tears (LMORT);
• Patients who underwent total or subtotal medial or lateral meniscectomy;
• Patients with grade III-IV chondral lesions according to the Outerbridge classification identified at the time of surgery;
• Patients who are unable to provide informed consent or who are unwilling to provide informed consent;
• Patients with insufficient and/or compromised bone quality or quantity due to disease, infection, or previous implantation, such that adequate support and/or fixation of the devices cannot be ensured;
• Patients with limited blood supply or a history of infections that could delay healing;
• Patients with sensitivity to foreign materials.

Sponsors & Collaborators

• Stefano Zaffagnini: lead

Study Sites (1)

IRCCS Rizzoli Orthopedic Institute

Bologna, 40136, Italy

Location

Central Study Contacts

Stefano Zaffagnini

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

IT (1)