Comparative Evaluation of Functional Results and Survival Rate of Peroneus Longus Tendon - PLT and Hamstring Tendon - HT Used for Reconstruction of the Anterior Cruciate Ligament.

NCT ID: NCT05579067

Last Updated: 2022-10-13

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2024-02-09

Brief Summary

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Comparative evaluation of functional results and survival rate of peroneus longus tendon - PLT and hamstring tendon - HT used for reconstruction of the anterior cruciate ligament.

Detailed Description

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Comparison of treatment results - survival and reconstruction of autographs and functional results of the knee joint, and functional results of the ankle joint, obtained in the study groups operated using two methods:

A- the use of a long fibular tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint; B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint.

Conditions

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Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Tear Knee Injuries Knee Ligament Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A- the use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint;

B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evaluation of functional results and survival rate of peroneus longus tendon used for ACLR.

Group Type EXPERIMENTAL

ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.

Intervention Type PROCEDURE

The use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.

Evaluation of functional results and survival rate of hamstring tendon used for ACL reconstruction.

Group Type ACTIVE_COMPARATOR

ACL Reconstruction using an autograph of Hamstrings muscle tendons.

Intervention Type PROCEDURE

The use of Hamstring muscle tendon autograft (Semitendinus and slender muscle) taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.

Interventions

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ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.

The use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.

Intervention Type PROCEDURE

ACL Reconstruction using an autograph of Hamstrings muscle tendons.

The use of Hamstring muscle tendon autograft (Semitendinus and slender muscle) taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-65 years;
* Surgery for ACL damage to the knee joint;
* Arthroscopic surgery;
* No prior knee surgical interventions;
* No additional pathologies in this anatomical area;
* Patient informed consent to participate in research.

Exclusion Criteria

* Age under 18 or over 65;
* Previous surgical interventions in the examined anatomical area;
* Additional pathologies in this area identified as part of preoperative diagnostics;
* Damage to the second knee joint;
* Failure to comply with the rigor of the same rehabilitation treatment protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

eMKa MED Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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eMKa MED Medical Center

Wroclaw, Dolnośląsk, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Maciej Kentel, MD PhD

Role: CONTACT

+48518744908

Kacper Kentel, Master's degree

Role: CONTACT

+48695263711

Facility Contacts

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Maciej Kentel, MD

Role: primary

+48518744908

Kacper Kentel, master's degree

Role: backup

+48695263711

Other Identifiers

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KB-84/2022

Identifier Type: -

Identifier Source: org_study_id

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