ACL Reconstruction With/Without ALL Reconstruction

NCT ID: NCT05461625

Last Updated: 2022-07-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

762 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-12-01

Brief Summary

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This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.

Detailed Description

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This study compare ACL reconstruction and additional tenodesis or ALL recontruction described by Arnold. Patients will be randomized fot this tree group and surgeon will be blinded.

Anterolateral ligament reconstruction could play a role in augmenting rotational stability in the ACL-reconstructed knee and are most likely to benefit hyperlax patients, revision cases, pivoting athletes, and those with IKDC grade III pivot shifts. In our study we will would like to confirm this hypothesis.

Conditions

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ACL Injury ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ACL

Anterior cruciate ligament reconstruction without additional procedure

Group Type SHAM_COMPARATOR

ACL reconstruction

Intervention Type PROCEDURE

Anterior cruciate ligament reconstruction

ACL + ALL anatomic

Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction

Group Type ACTIVE_COMPARATOR

ACL reconstruction

Intervention Type PROCEDURE

Anterior cruciate ligament reconstruction

ALL anatomic

Intervention Type OTHER

anatomic anterolateral ligament reconstruction

ACL + ALL tenodesis

Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis

Group Type ACTIVE_COMPARATOR

ACL reconstruction

Intervention Type PROCEDURE

Anterior cruciate ligament reconstruction

ALL tenodesis

Intervention Type OTHER

anterolateral ligament teondesis

Interventions

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ACL reconstruction

Anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

ALL anatomic

anatomic anterolateral ligament reconstruction

Intervention Type OTHER

ALL tenodesis

anterolateral ligament teondesis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- primary ACL injury

Exclusion Criteria

* no informed consent to participate in the study
* age under 18 years or above 65
* multilligament injury or single plane knee instability (medial, lateral)
* another musculoskeletal disorders in lower limb
* lower limb deformity requiring axis correction below 4o or above 12.5o
* joints inflammatory diseases
* ASA score \> II
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role lead

Responsible Party

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Rafał Kamiński

Professor CMKP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafal Kaminski

Role: STUDY_CHAIR

SPSK CMKP

Locations

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Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital

Otwock, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Rafal Kaminski

Role: CONTACT

+48227794031

Facility Contacts

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Rafal Kaminski, MD PhD

Role: primary

+48227794031 ext. 469

Stanislaw Pomianowski, MD PhD Prof

Role: backup

+48227794031 ext. 481

Other Identifiers

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ACL_ALL

Identifier Type: -

Identifier Source: org_study_id

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