Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303726
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-07-27
Brief Title:
Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction
Sponsor:
University Medical Centre Maribor
Organization:
University Medical Centre Maribor
Study Overview
Official Title:
Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction Short-term and Long-term Function and Imaging Results
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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:
None
Brief Summary:
The goal of this retrospective randomized study is to compare two surgical techniques single vs double bundle of ACL anterior cruciate ligament reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee exclusion criteria defined
The main question it aims to answer are
which surgery gives better outcome in patients short- and long-term results
are there any sings of osteoarthritis in an injured knee compared to a healthy knee
Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging MRI of both knees Subjective exams with different scores Tegner score Lysholm score were also done The same exam protocol for participant was used again after two years and fifteen years since surgery
The main question it aims to answer are
which surgery gives better outcome in patients short- and long-term results
are there any sings of osteoarthritis in an injured knee compared to a healthy knee
Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging MRI of both knees Subjective exams with different scores Tegner score Lysholm score were also done The same exam protocol for participant was used again after two years and fifteen years since surgery
Detailed Description:
Double bundle DB ACL reconstruction has gained popularity in the last few years Biomechanical and intra - operative studies have shown better antero - posterior and rotational stability after DB vs single bundle SB reconstruction However only few studies are found in the literature that have evaluated and compared clinical results between SB and DB ACL reconstruction All reported studies used hamstrings in both DB and SB techniques No studies were found that used patellar tendon autograft for the SB
The purpose of the present study was therefore to evaluate and compare the clinical results of DB hamstring and SB patellar tendon ACL reconstruction techniques
A total of 40 patients 29 male and 11 female average SD age 36 were randomized during routine surgery 2 years after the surgery into either double bundle DB or single bundle SB group Patients with combined medial lateral or posterior ligamentous injuries were not included in the study ACL reconstruction in DB group was done by four tunnel hamstring technique with EndoButton femoral and cancellous screw tibial fixation In the SB group patellar tendon autograft was fixed with titanium interference screws The same postoperative rehabilitation protocols were used for both groups
Subjective evaluation comprised IKDC International Knee Documentation Committee subjective score Tegner activity and Lysholm scores Objective evaluation was done by the IKDC 2000 knee examination protocol Antero - posterior stability was measured by KT 2000 knee arthrometer and by Rollimeter One leg hop test was performed to assess the functional results Isokinetic thigh muscle strength measurements on Biodex isokinetic dynamometer were performed
The same protocol was performed for the clinical exams after 15 years since surgery A total of 30 patients were examen Investigators also did imaging of both knees X-ray and MRI for checking the sings of osteoarthritis
The purpose of the present study was therefore to evaluate and compare the clinical results of DB hamstring and SB patellar tendon ACL reconstruction techniques
A total of 40 patients 29 male and 11 female average SD age 36 were randomized during routine surgery 2 years after the surgery into either double bundle DB or single bundle SB group Patients with combined medial lateral or posterior ligamentous injuries were not included in the study ACL reconstruction in DB group was done by four tunnel hamstring technique with EndoButton femoral and cancellous screw tibial fixation In the SB group patellar tendon autograft was fixed with titanium interference screws The same postoperative rehabilitation protocols were used for both groups
Subjective evaluation comprised IKDC International Knee Documentation Committee subjective score Tegner activity and Lysholm scores Objective evaluation was done by the IKDC 2000 knee examination protocol Antero - posterior stability was measured by KT 2000 knee arthrometer and by Rollimeter One leg hop test was performed to assess the functional results Isokinetic thigh muscle strength measurements on Biodex isokinetic dynamometer were performed
The same protocol was performed for the clinical exams after 15 years since surgery A total of 30 patients were examen Investigators also did imaging of both knees X-ray and MRI for checking the sings of osteoarthritis
Study Oversight
Has Oversight DMC:
None
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?:
None