Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT05579067
Status:
UNKNOWN
Last Update Posted:
2022-10-13
First Post:
2022-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D022125', 'term': 'Lacerations'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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;\n\nB- 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-02-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Score (VAS)', 'timeFrame': '1 day', 'description': 'Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:\n\n* 0 to 4 mm can be considered no pain;\n* 5 to 44 mm, mild pain;\n* 45 to 74 mm, moderate pain;\n* 75 to 100 mm, severe pain.'}, {'measure': 'Visual Analogue Score (VAS)', 'timeFrame': '3 months after procedure', 'description': 'Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:\n\n* 0 to 4 mm can be considered no pain;\n* 5 to 44 mm, mild pain;\n* 45 to 74 mm, moderate pain;\n* 75 to 100 mm, severe pain.'}, {'measure': 'Visual Analogue Score (VAS)', 'timeFrame': '6 months after procedure', 'description': 'Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:\n\n* 0 to 4 mm can be considered no pain;\n* 5 to 44 mm, mild pain;\n* 45 to 74 mm, moderate pain;\n* 75 to 100 mm, severe pain.'}, {'measure': 'Tegner Activity Level Scale (TAS)', 'timeFrame': '1 day', 'description': '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.\n\nThe 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.'}, {'measure': 'Tegner Activity Level Scale (TAS)', 'timeFrame': '3 months after procedure', 'description': '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.\n\nThe 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.'}, {'measure': 'Tegner Activity Level Scale (TAS)', 'timeFrame': '6 months after procedure', 'description': '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.\n\nThe 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.'}, {'measure': 'IKDC SUBJECTIVE KNEE EVALUATION FORM', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'IKDC SUBJECTIVE KNEE EVALUATION FORM', 'timeFrame': '3 months after procedure', 'description': '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.'}, {'measure': 'IKDC SUBJECTIVE KNEE EVALUATION FORM', 'timeFrame': '6 months after procedure', 'description': '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.'}, {'measure': 'Tegner Lysholm Knee Scoring Scale', 'timeFrame': '1 day', 'description': '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).\n\nGrading the Tegner Lysholm Knee Scoring Scale:\n\n* \\<65 - poor;\n* 65-83 - fair;\n* 84-90 - good;\n* \\>90 - excellent.'}, {'measure': 'Tegner Lysholm Knee Scoring Scale', 'timeFrame': '3 months after procedure', 'description': '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).\n\nGrading the Tegner Lysholm Knee Scoring Scale:\n\n* \\<65 - poor;\n* 65-83 - fair;\n* 84-90 - good;\n* \\>90 - excellent.'}, {'measure': 'Tegner Lysholm Knee Scoring Scale', 'timeFrame': '6 months after procedure', 'description': '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).\n\nGrading the Tegner Lysholm Knee Scoring Scale:\n\n* \\<65 - poor;\n* 65-83 - fair;\n* 84-90 - good;\n* \\>90 - excellent.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '1 day', 'description': 'BMI is interpreted using standard weight status categories:\n\nI : below 18.5 kg/m2 - underweight;\n\nII : 18.5 - 24.9 kg/m2 - healthy weight;\n\nIII : 25.0 - 29.9 kg/m2 - overweight;\n\nIV : 30.0 kg/m2 and above - obesity.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '3 months after procedure', 'description': 'BMI is interpreted using standard weight status categories:\n\nI : below 18.5 kg/m2 - underweight;\n\nII : 18.5 - 24.9 kg/m2 - healthy weight;\n\nIII : 25.0 - 29.9 kg/m2 - overweight;\n\nIV : 30.0 kg/m2 and above - obesity.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '6 months after procedure', 'description': 'BMI is interpreted using standard weight status categories:\n\nI : below 18.5 kg/m2 - underweight;\n\nII : 18.5 - 24.9 kg/m2 - healthy weight;\n\nIII : 25.0 - 29.9 kg/m2 - overweight;\n\nIV : 30.0 kg/m2 and above - obesity.'}, {'measure': 'The American Orthopedic Foot and Ankle Score (AOFAS)', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'The American Orthopedic Foot and Ankle Score (AOFAS)', 'timeFrame': '3 month after procedure', 'description': '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.'}, {'measure': 'The American Orthopedic Foot and Ankle Score (AOFAS)', 'timeFrame': '6 month after procedure', 'description': '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.'}, {'measure': 'Biomechanical examination', 'timeFrame': '3 months after procedure', 'description': 'On the Biodex 3 System measuring device'}, {'measure': 'Biomechanical examination', 'timeFrame': '6 months after procedure', 'description': 'On the Biodex 3 System measuring device'}, {'measure': 'Ultrasonography (USG)', 'timeFrame': '6 months after procedure', 'description': 'Ultrasound examination on the apparatus with the option of elastometry'}, {'measure': 'Magnetic resonance imaging (MRI)', 'timeFrame': '6 months after procedure', 'description': '1,5 Tesli'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Injuries', 'Rupture', 'Tear', 'ACL', 'Reconstruction', 'Techniques'], 'conditions': ['Anterior Cruciate Ligament Injuries', 'Anterior Cruciate Ligament Rupture', 'Anterior Cruciate Ligament Tear', 'Knee Injuries', 'Knee Ligament Injury']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\nA- 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Men operated on for instability of the knee joint as a result of damage to the anterior cruciate ligament.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years;\n* Surgery for ACL damage to the knee joint;\n* Arthroscopic surgery;\n* No prior knee surgical interventions;\n* No additional pathologies in this anatomical area;\n* Patient informed consent to participate in research.\n\nExclusion Criteria:\n\n* Age under 18 or over 65;\n* Previous surgical interventions in the examined anatomical area;\n* Additional pathologies in this area identified as part of preoperative diagnostics;\n* Damage to the second knee joint;\n* Failure to comply with the rigor of the same rehabilitation treatment protocol.'}, 'identificationModule': {'nctId': 'NCT05579067', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'eMKa MED Medical Center'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'KB-84/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation of functional results and survival rate of peroneus longus tendon used for ACLR.', 'interventionNames': ['Procedure: ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Evaluation of functional results and survival rate of hamstring tendon used for ACL reconstruction.', 'interventionNames': ['Procedure: ACL Reconstruction using an autograph of Hamstrings muscle tendons.']}], 'interventions': [{'name': 'ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Evaluation of functional results and survival rate of peroneus longus tendon used for ACLR.']}, {'name': 'ACL Reconstruction using an autograph of Hamstrings muscle tendons.', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Evaluation of functional results and survival rate of hamstring tendon used for ACL reconstruction.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53-110', 'city': 'Wroclaw', 'state': 'Dolnośląsk', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maciej Kentel, MD', 'role': 'CONTACT', 'email': 'emkamed.cm@gmail.com', 'phone': '+48518744908'}, {'name': "Kacper Kentel, master's degree", 'role': 'CONTACT', 'email': 'kacper.kentel@emkamed.com.pl', 'phone': '+48695263711'}], 'facility': 'eMKa MED Medical Center', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Maciej Kentel, MD PhD', 'role': 'CONTACT', 'email': 'emkamed.cm@gmail.com', 'phone': '+48518744908'}, {'name': "Kacper Kentel, Master's degree", 'role': 'CONTACT', 'email': 'kacper.kentel@emkamed.com.pl', 'phone': '+48695263711'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'eMKa MED Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wroclaw Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}