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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.

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05579067
Enrollment
60
Registered
2022-10-13
Start date
2022-02-02
Completion date
2024-02-09
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Injuries, Rupture, Tear, ACL, Reconstruction, Techniques

Brief summary

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

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.

Interventions

PROCEDUREACL 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.

PROCEDUREACL 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.

Sponsors

Wroclaw Medical University
CollaboratorOTHER
eMKa MED Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Score (VAS)1 dayVisual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: * 0 to 4 mm can be considered no pain; * 5 to 44 mm, mild pain; * 45 to 74 mm, moderate pain; * 75 to 100 mm, severe pain.
Tegner Activity Level Scale (TAS)1 dayThe Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
IKDC SUBJECTIVE KNEE EVALUATION FORM1 dayInterpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
Tegner Lysholm Knee Scoring Scale1 dayThe Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: * \<65 - poor; * 65-83 - fair; * 84-90 - good; * \>90 - excellent.
Body Mass Index (BMI)1 dayBMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.
The American Orthopedic Foot and Ankle Score (AOFAS)1 dayis a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.
Biomechanical examination3 months after procedureOn the Biodex 3 System measuring device
Ultrasonography (USG)6 months after procedureUltrasound examination on the apparatus with the option of elastometry
Magnetic resonance imaging (MRI)6 months after procedure1,5 Tesli

Countries

Poland

Contacts

Primary ContactMaciej Kentel, MD PhD
emkamed.cm@gmail.com+48518744908
Backup ContactKacper Kentel, Master's degree
kacper.kentel@emkamed.com.pl+48695263711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026