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

NCT06303726 | Unknown

• 1 other identifier: IRP-2021/02-19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

anterior cruciate ligament; bone to bone (BTB); single bundle; double bundle

Outcome Measures

Primary Outcomes (5)

• IKDC SUBJECTIVE SCORE

  Daily activities, limitations

  before surgery, 2 years and 15 years after surgery

• TEGNER SCORE

  Daily activities, limitations

  2 years and 15 years after surgery

• LYSHOLM SCORE

  Daily activities, limitations

  2 years and 15 years after surgery

• OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS

  Measurements with Biodex isokinetic Dynamometer (deficit (%) at 60 deg/s and 180 deg/s; operated to nonoperated ratio (total work))

  2 years and 15 years after surgery

• OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior)

  Measured by KT 1000 and Rollimeter. Laxity was expressed as the difference between injured knee and uninjured knee in millimeters.

  2 years and 15 years after surgery

Study Arms (2)

Single bundle ACL reconstruction

ACTIVE COMPARATOR

In this group we chose to do surgery of ACL reconstruction with single bundle (patellar ligament).

Procedure: ACL reconstruction single bundle

Double bundle ACL reconstruction

ACTIVE COMPARATOR

In this group we chose to do surgery of ACL reconstruction with double bundle - hamstring ligament.

Procedure: ACL reconstruction double bundle

Interventions

ACL reconstruction single bundle PROCEDURE

We will do surgery of ACL reconstruction with patellar ligament.

Single bundle ACL reconstruction

ACL reconstruction double bundle PROCEDURE

We will do surgery of ACL reconstruction with hamstring ligament.

Double bundle ACL reconstruction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• complete ACL rupture
• symptoms and clinical sings for rupture of ACL (instability of knee, swelling, pain, reduced knee function,...)
• patient consent
• magnetic resonance with this of kind injury

You may not qualify if:

• associated injuries to other knee ligaments
• major meniscus injuries
• X-ray abnormalities of injured knee
• preliminary ACL reconstruction
• associated injury to the other knee

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (1)

University Clinical Center Maribor

Maribor, 2000, Slovenia

Location

Related Publications (15)

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  PMID: 33945339 BACKGROUND

Study Officials

• Mitja Kozic

  University Clinical Center Maribor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: March 12, 2024
• Study Start: April 25, 2022
• Primary Completion: April 1, 2024
• Study Completion: June 25, 2024
• Last Updated: March 12, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)