Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT05580133
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Mongi Slim Hospital
Organization:
Study Overview
Official Title:
All-Inside Single-Bundle for ACL Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACL
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: