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.

NCT05579067 | Unknown

• 1 other identifier: KB-84/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (22)

• Visual Analogue Score (VAS)

  Visual 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.

  1 day

• Visual Analogue Score (VAS)

  Visual 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.

  3 months after procedure

• Visual Analogue Score (VAS)

  Visual 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.

  6 months after procedure

• Tegner Activity Level Scale (TAS)

  The 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.

  1 day

• Tegner Activity Level Scale (TAS)

  The 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.

  3 months after procedure

• Tegner Activity Level Scale (TAS)

  The 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.

  6 months after procedure

• IKDC SUBJECTIVE KNEE EVALUATION FORM

  Interpreted 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.

  1 day

• IKDC SUBJECTIVE KNEE EVALUATION FORM

  Interpreted 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.

  3 months after procedure

• IKDC SUBJECTIVE KNEE EVALUATION FORM

  Interpreted 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.

  6 months after procedure

• Tegner Lysholm Knee Scoring Scale

  The 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.

  1 day

• Tegner Lysholm Knee Scoring Scale

  The 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.

  3 months after procedure

• Tegner Lysholm Knee Scoring Scale

  The 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.

  6 months after procedure

• Body Mass Index (BMI)

  BMI 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.

  1 day

• Body Mass Index (BMI)

  BMI 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.

  3 months after procedure

• Body Mass Index (BMI)

  BMI 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.

  6 months after procedure

• The American Orthopedic Foot and Ankle Score (AOFAS)

  is 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.

  1 day

• The American Orthopedic Foot and Ankle Score (AOFAS)

  is 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.

  3 month after procedure

• The American Orthopedic Foot and Ankle Score (AOFAS)

  is 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.

  6 month after procedure

• Biomechanical examination

  On the Biodex 3 System measuring device

  3 months after procedure

• Biomechanical examination

  On the Biodex 3 System measuring device

  6 months after procedure

• Ultrasonography (USG)

  Ultrasound examination on the apparatus with the option of elastometry

  6 months after procedure

• Magnetic resonance imaging (MRI)

  1,5 Tesli

  6 months after procedure

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

Procedure: ACL Reconstruction using an autograph of Hamstrings muscle tendons.

Interventions

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

ACL Reconstruction using an autograph of Hamstrings muscle tendons. 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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Men operated on for instability of the knee joint as a result of damage to the anterior cruciate ligament.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• eMKa MED Medical Center: lead
• Wroclaw Medical University: collaborator

Study Sites (1)

eMKa MED Medical Center

Wroclaw, Dolnośląsk, 53-110, Poland

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries; Wounds and Injuries; Rupture; Lacerations

Condition Hierarchy (Ancestors)

Leg Injuries

Central Study Contacts

Maciej Kentel, MD PhD

CONTACT

+48518744908; emkamed.cm@gmail.com

Kacper Kentel, Master's degree

CONTACT

+48695263711; kacper.kentel@emkamed.com.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: October 13, 2022
• Study Start: February 2, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 9, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)