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)
ACL
1 other identifier
observational
80
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2023
CompletedOctober 14, 2022
October 1, 2022
10 months
September 27, 2022
October 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
the anterior drawer test
the anterior drawer test is used to assess the integrity of the anterior cruciate ligament. With the knee flexed to 90 degrees, the foot is stabilized by sitting on it. The proximal tibia is grasped firmly with both hands, and the tibia is forcibly pulled anteriorly, noting any or abnormal movement compared with the opposite side. to estimate how severe the injury is by how far they can displace the ACL. They grade the tear from one to three (I, II, or III), with three being the worst tear. A grade I tear moves 5 millimeters, a grade II tear moves between 5 and 10 millimeters, and a grade III tear moves more than 10 millimeters.
Baseline,
the anterior drawer test
the anterior drawer test is used to assess the integrity of the anterior cruciate ligament. With the knee flexed to 90 degrees, the foot is stabilized by sitting on it. The proximal tibia is grasped firmly with both hands, and the tibia is forcibly pulled anteriorly, noting any or abnormal movement compared with the opposite side. to estimate how severe the injury is by how far they can displace the ACL. They grade the tear from one to three (I, II, or III), with three being the worst tear. A grade I tear moves 5 millimeters, a grade II tear moves between 5 and 10 millimeters, and a grade III tear moves more than 10 millimeters.
Month 8
The pivot shift
The pivot shift is a dynamic but passive test of knee stability, carried out by the examiner without any activity of the patient. It shows a dysregulation between rolling and gliding in the knee joint. The patient lies in supine. The movement is a combination of axial load and valgus force, applied by the examiner, during a knee flexion from an extended position. When the test is positive, it indicates an injury of the anterior cruciate ligament
Baseline
The pivot shift
The pivot shift is a dynamic but passive test of knee stability, carried out by the examiner without any activity of the patient. It shows a dysregulation between rolling and gliding in the knee joint. The patient lies in supine. The movement is a combination of axial load and valgus force, applied by the examiner, during a knee flexion from an extended position. When the test is positive, it indicates an injury of the anterior cruciate ligament
Month 8
Visual Analogue Scale (VAS)
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Baseline
Visual Analogue Scale (VAS)
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Week 3
International Knee Documentation Committee (IKDC) 2000 subjective score
The score is 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 activities of daily living or sports activities and the absence of symptoms.
Baseline
International Knee Documentation Committee (IKDC) 2000 subjective score
The score is 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 activities of daily living or sports activities and the absence of symptoms.
Month 8
knee joint arthrometers
a value less than 3 mm means that there is no ACL injury difference residing between 3 and 5 mm, it is considered that anterior posterior laxity is unusually high. The ACL might therefore be partially or completely torn. difference higher than 5 mm, it is considered that anterior posterior laxity is very high which indicates a complete ACL tear.
Baseline
knee joint arthrometers
a value less than 3 mm means that there is no ACL injury difference residing between 3 and 5 mm, it is considered that anterior posterior laxity is unusually high. The ACL might therefore be partially or completely torn. difference higher than 5 mm, it is considered that anterior posterior laxity is very high which indicates a complete ACL tear.
Month 8
Study Arms (2)
Peroneus Longus Tendon autograft
All-Inside Single-Bundle for ACL Reconstruction with Full Thickness of the Peroneus Longus Tendon
six-strand-hamstring autograft
All-Inside Single-Bundle for ACL Reconstruction with six-strand-hamstring autograft
Interventions
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.
Eligibility Criteria
study population is a young athletic population with anterior laxity of the knee secondary to anterior cruciate ligament injury
You may qualify if:
- primary ACL rupture in adult patients
You may not qualify if:
- serious osteoarthritis
- revision cases
- multiple ligament injuries
- ankle injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 8 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, medical doctor, assistant professor
Study Record Dates
First Submitted
September 27, 2022
First Posted
October 14, 2022
Study Start
October 10, 2022
Primary Completion
August 10, 2023
Study Completion
September 10, 2023
Last Updated
October 14, 2022
Record last verified: 2022-10