Anterior Cruciate Ligament Tear Clinical Trial
Official title:
Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation
This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 60 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ahmet E. Okutan | Samsun | |
Turkey | Samsun University | Samsun |
Lead Sponsor | Collaborator |
---|---|
Samsun University |
Turkey,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Signal to Noise Quotient | Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation | 1 year | |
Secondary | Difference in Computed Tomography (CT) imaging of Tunnels | Femoral and Tibial Tunnel Morphological Changes | 1 day, 6 months, 1 year | |
Secondary | International Knee Documentation Committee (IKDC) | Patient reported outcome measures of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | 1 year | |
Secondary | Marx Activity Rating Score | Clinical Outcomes | 1 year | |
Secondary | Side to side difference in anterior tibial translation | Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer | 6 weeks, 3 months, 6 months, 9 months, 1 year |
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