Clinical trial NCT05580133: 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)
Official title: All-Inside Single-Bundle for ACL Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior cruciate ligament
peroneus longus tendon
Hamstring Tendons
donor site
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 80
Sex: ALL
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: study population is a young athletic population with anterior laxity of the knee secondary to anterior cruciate ligament injury

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.

Detailed description: prospective randomized clinical study to compare the results of all-inside anatomical ACL reconstruction using the AHPLT and using Six-strand- tendon autograft.

Randomization will be done with inclusion criteria of primary ACL rupture in adult patients and exclusion criteria of serious osteoarthritis, revision cases, and multiple ligament injuries.

Preoperatively, physical examinations including the anterior drawer test and the pivot shift Test were performed to judge the stability of the knee joint. All of the patients will be evaluated with an International Knee Documentation Committee (IKDC) 2000 subjective score, a Visual Analogue Scale (VAS), and an American Orthopedic Foot and Ankle Score (AOFAS).a knee joint arthrometers was also used with knee flexion of 30° at 134 N.

All of the tests will be performed three times by another experienced orthopedic surgeon who is not involved in the surgery, and the mean of the three measurements will be taken as the final value.

Eligibility criteria: Inclusion Criteria:

* primary ACL rupture in adult patients

Exclusion Criteria:

* serious osteoarthritis
* revision cases
* multiple ligament injuries
* ankle injuries

Primary outcomes:
measure: the anterior drawer test
timeFrame: Baseline,
measure: the anterior drawer test
timeFrame: Month 8
measure: The pivot shift
timeFrame: Baseline
measure: The pivot shift
timeFrame: Month 8
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline
measure: Visual Analogue Scale (VAS)
timeFrame: Week 3
measure: International Knee Documentation Committee (IKDC) 2000 subjective score
timeFrame: Baseline
measure: International Knee Documentation Committee (IKDC) 2000 subjective score
timeFrame: Month 8
measure: knee joint arthrometers
timeFrame: Baseline
measure: knee joint arthrometers
timeFrame: Month 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: