All-Inside Single-Bundle for Anterior Cruciate Ligament Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft (ACL)

NCT ID: NCT05580133

Last Updated: 2022-10-14

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

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2023-09-10

Brief Summary

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Anterior cruciate ligament reconstruction is the current gold standard for restoring knee stability. Hamstring tendon (HT) autograft is the most popular graft choice for ACL reconstruction worldwide. Other autografts include bone-patellar tendon-bone and quadriceps tendon, yet no globally accepted gold standard of graft choice exists for use in ACL reconstruction.

The peroneus longus tendon (PLT) has been reported as an autograft choice for ligament reconstruction\[2\], but there is little information regarding the clinical outcomes using the peroneus longus tendon (AHPLT) compared with hamstring tendon autograft. Therefore, we are interested in investigating whether the clinical outcomes of the PLT autograft were equivalent to the Six-strand- hamstring tendon autograft.

Detailed Description

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prospective randomized clinical study to compare the results of all-inside anatomical ACL reconstruction using the AHPLT and using Six-strand- tendon autograft.

Randomization will be done with inclusion criteria of primary ACL rupture in adult patients and exclusion criteria of serious osteoarthritis, revision cases, and multiple ligament injuries.

Preoperatively, physical examinations including the anterior drawer test and the pivot shift Test were performed to judge the stability of the knee joint. All of the patients will be evaluated with an International Knee Documentation Committee (IKDC) 2000 subjective score, a Visual Analogue Scale (VAS), and an American Orthopedic Foot and Ankle Score (AOFAS).a knee joint arthrometers was also used with knee flexion of 30° at 134 N.

All of the tests will be performed three times by another experienced orthopedic surgeon who is not involved in the surgery, and the mean of the three measurements will be taken as the final value.

Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Peroneus Longus Tendon autograft

All-Inside Single-Bundle for ACL Reconstruction with Full Thickness of the Peroneus Longus Tendon

anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

Arthroscopic reconstruction of the anterior cruciate ligament is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore function after injury.

six-strand-hamstring autograft

All-Inside Single-Bundle for ACL Reconstruction with six-strand-hamstring autograft

anterior cruciate ligament reconstruction

Intervention Type PROCEDURE

Arthroscopic reconstruction of the anterior cruciate ligament is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore function after injury.

Interventions

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anterior cruciate ligament reconstruction

Arthroscopic reconstruction of the anterior cruciate ligament is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore function after injury.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary ACL rupture in adult patients

Exclusion Criteria

* serious osteoarthritis
* revision cases
* multiple ligament injuries
* ankle injuries
Minimum Eligible Age

17 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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mohamed hedi ezzine

Principal Investigator, medical doctor, assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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mongislim

Identifier Type: -

Identifier Source: org_study_id

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