A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament

NCT ID: NCT03746470

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2024-09-29

Brief Summary

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This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy.

The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .

Detailed Description

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Conditions

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Complete Tear, Knee, Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insertion preserving

ACL reconstruction preserving insertion

Group Type EXPERIMENTAL

ACL reconstruction preserving insertion

Intervention Type PROCEDURE

Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.

insertion detaching

ACL reconstruction detaching insertion

Group Type ACTIVE_COMPARATOR

ACL reconstruction detaching insertion

Intervention Type PROCEDURE

Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.

Interventions

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ACL reconstruction preserving insertion

Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.

Intervention Type PROCEDURE

ACL reconstruction detaching insertion

Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 55
* MRI confirmed primary and total ACL injury of traumatic origin
* Indication for ACL reconstruction in arthroscopy
* Written informed consent
* Active and non-sedentary lifestyle

Exclusion Criteria

* Complex meniscal injuries
* Cartilage lesions of sizes\> 2 cm2
* Other ligamentous lesions
* Axis deviations greater than 10°
* Rheumatic, neuromuscular or general systemic diseases
* Prevention of injured knee traumas treated surgically
* Difficulties in compliance in following the rehabilitation programs
* Obesity (BMI ≥ 30)
* Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role collaborator

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Decogliano, MD

Role: STUDY_CHAIR

EOC - Unità Traumatologia e Ortopedia - ORL

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

EOC - Unità Traumatologia e Ortopedia ORL

Lugano, , Switzerland

Site Status

Countries

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Italy Switzerland

Other Identifiers

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ORL-ORT-003

Identifier Type: -

Identifier Source: org_study_id

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