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Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction

NCT06303726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-12

No results posted yet for this study

Summary

The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).

The main question it aims to answer are:

* which surgery gives better outcome in patients (short- and long-term results)?
* are there any sings of osteoarthritis in an injured knee compared to a healthy knee?

Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery.

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

PROCEDURE

ACL reconstruction single bundle

We will do surgery of ACL reconstruction with patellar ligament.

PROCEDURE

ACL reconstruction double bundle

We will do surgery of ACL reconstruction with hamstring ligament.

Sponsors & Collaborators

  • University Medical Centre Maribor

    lead OTHER

Principal Investigators

  • Mitja Kozic · University Clinical Center Maribor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2024-04-01
Completion
2024-06-25

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303726 on ClinicalTrials.gov