Clinical trial NCT05574946: Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique
Official title: Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 80 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.

Detailed description: This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 80 patients with ACL rupture were recruited according to the enrollment criteria. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. In this study, 40 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 40 patients with ACL rupture in the control group will be treated with complete tibial tunnel technique. All operations will be performed with 4-strand autologous semitendinosus tendon. All fixations will be performed using an adjustable cortical suspensory system. After reconstruction, all subjects will participate in the collection of clinical function scores including Marx Activity score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis.

Eligibility criteria: Inclusion Criteria:

* Patients who have provided informed written written consent;
* Patients aged between 18 and 45;
* Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
* Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft

Exclusion Criteria:

* Patients who have not signed informed consent;
* Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
* Revision procedures
* Patients unable to lay still in an MRI or CT scanner
* Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
* Patients who had an excessive tibial slope \>12 degrees

Primary outcomes:
measure: Signal to Noise Quotient
timeFrame: 1 year
Secondary outcomes:
measure: Difference in Computed Tomography (CT) imaging of Tunnels
timeFrame: 1 day, 6 months, 1 year
measure: International Knee Documentation Committee (IKDC)
timeFrame: 1 year
measure: Marx Activity Rating Score
timeFrame: 1 year
measure: Side to side difference in anterior tibial translation
timeFrame: 6 weeks, 3 months, 6 months, 9 months, 1 year
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ahmet E. Okutan
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
References:
citation: Bhimani R, Shahriarirad R, Ranjbar K, Erfani A, Ashkani-Esfahani S. Transportal versus all-inside techniques of anterior cruciate ligament reconstruction: a systematic review. J Orthop Surg Res. 2021 Dec 23;16(1):734. doi: 10.1186/s13018-021-02872-x.
citation: Colombet P, Saffarini M, Bouguennec N. Clinical and Functional Outcomes of Anterior Cruciate Ligament Reconstruction at a Minimum of 2 Years Using Adjustable Suspensory Fixation in Both the Femur and Tibia: A Prospective Study. Orthop J Sports Med. 2018 Oct 22;6(10):2325967118804128. doi: 10.1177/2325967118804128. eCollection 2018 Oct.