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

March 4, 2024 updated by: University Medical Centre Maribor

Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction: Short-term and Long-term Function and Imaging Results

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.

Study Overview

Status

Active, not recruiting

Conditions

Anterior Cruciate Ligament Reconstruction

Intervention / Treatment

Detailed Description

Double bundle (DB) ACL reconstruction has gained popularity in the last few years. Biomechanical and intra - operative studies have shown better antero - posterior and rotational stability after DB vs. single bundle (SB) reconstruction. However, only few studies are found in the literature that have evaluated and compared clinical results between SB and DB ACL reconstruction. All reported studies used hamstrings in both DB and SB techniques. No studies were found that used patellar tendon autograft for the SB.

The purpose of the present study was therefore to evaluate and compare the clinical results of DB hamstring and SB patellar tendon ACL reconstruction techniques.

A total of 40 patients (29 male and 11 female, average (SD) age 36) were randomized during routine surgery (2 years after the surgery) into either double bundle (DB) or single bundle (SB) group. Patients with combined (medial, lateral or posterior) ligamentous injuries were not included in the study. ACL reconstruction in DB group was done by four tunnel hamstring technique with EndoButton femoral and cancellous screw tibial fixation. In the SB group patellar tendon autograft was fixed with titanium interference screws. The same postoperative rehabilitation protocols were used for both groups.

Subjective evaluation comprised IKDC (International Knee Documentation Committee) subjective score, Tegner activity and Lysholm scores. Objective evaluation was done by the IKDC 2000 knee examination protocol. Antero - posterior stability was measured by KT 2000 (knee arthrometer) and by Rollimeter. One leg hop test was performed to assess the functional results. Isokinetic thigh muscle strength measurements on Biodex isokinetic dynamometer were performed.

The same protocol was performed for the clinical exams after 15 years since surgery. A total of 30 patients were examen. Investigators also did imaging of both knees (X-ray and MRI) for checking the sings of osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Slovenia
- - Maribor, Slovenia, 2000
    - University clinical center Maribor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single bundle ACL reconstruction In this group we chose to do surgery of ACL reconstruction with single bundle (patellar ligament).	Procedure: ACL reconstruction single bundle We will do surgery of ACL reconstruction with patellar ligament.
Active Comparator: Double bundle ACL reconstruction In this group we chose to do surgery of ACL reconstruction with double bundle - hamstring ligament.	Procedure: ACL reconstruction double bundle We will do surgery of ACL reconstruction with hamstring ligament.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC SUBJECTIVE SCORE Time Frame: before surgery, 2 years and 15 years after surgery	Daily activities, limitations	before surgery, 2 years and 15 years after surgery
TEGNER SCORE Time Frame: 2 years and 15 years after surgery	Daily activities, limitations	2 years and 15 years after surgery
LYSHOLM SCORE Time Frame: 2 years and 15 years after surgery	Daily activities, limitations	2 years and 15 years after surgery
OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS Time Frame: 2 years and 15 years after surgery	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) Time Frame: 2 years and 15 years after surgery	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Maribor

Investigators

Study Chair: Mitja Kozic, University clinical center Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 25, 2024

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

IRP-2021/02-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Fo now we are not planning to share any participant data to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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