ACL reconstruction using the Over-The-Top technique with either metal staples or soft anchors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing ACL reconstruction with the Over-The-Top technique are enrolled to compare fixation methods using either metal staples or soft anchors. The focus is on mid-term knee stability and function after surgery, with attention to graft fixation quality and patient-reported outcomes. The study follows standard postoperative care and evaluates outcomes at defined intervals to identify differences in fixation-related complications and knee performance. This is an interventional study without a specified phase, centered on a surgical technique rather than a drug or device alone. Eligibility excludes complex ligament injuries and certain meniscal or cartilage conditions to create a relatively uniform patient group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients of either sex, aged between 18 and 50 years at the time of surgery;
2. 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;

4\. Patients who have signed the informed consent form.

Exclusion Criteria:

1. Patients with associated injury of the medial collateral ligament (MCL), lateral collateral ligament (LCL), posterolateral corner (PLC), or posterior cruciate ligament (PCL);
2. Patients with complete meniscal root tears, complete radial tears, or lateral meniscus oblique tears (LMORT);
3. Patients who underwent total or subtotal medial or lateral meniscectomy;
4. Patients with grade III-IV chondral lesions according to the Outerbridge classification identified at the time of surgery;
5. Patients who are unable to provide informed consent or who are unwilling to provide informed consent;
6. 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;
7. Patients with limited blood supply or a history of infections that could delay healing;
8. Patients with sensitivity to foreign materials.

Where it's running

• IRCCS Rizzoli Orthopedic Institute
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Stefano Zaffagnini
• Email: stefano.zaffagnini@ior.it
• Phone: 0516366075

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.