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IRCT20200305046700N15 IRCT 2026-07-23 Tehran University of Medical Sciences Effect of Kaplan Tenodesis on ACL Reconstruction Outcomes Comparative study of treatment outcome in patients with anterior cruciate ligament injury undergoing reconstruction surgery with or without distal Kaplan tenodesis: a randomized clinical trial 2025-12-22 anticipated 60 Recruiting https://irct.ir/trial/84889 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using random permuted blocks with fixed size of 4. The sequence will be generated by a random number generator in Excel and placed in numbered, sealed, opaque envelopes. At the time of surgery, the next envelope will be opened by an individual independent of the surgical team, and the patient will be allocated to one of two groups (distal Kaplan tenodesis or no tenodesis) based on the code inside. Allocation concealment is ensured as those involved in recruitment, surgery, and assessment are unaware of the sequence, Blinding description: In this study, patients, the clinical evaluator, and the data analyst are blinded to the type of procedure (with or without distal Kaplan tenodesis). Only the surgeon is aware of the procedure due to the nature of the intervention. Patients are not informed before surgery and observe no difference in dressings or wound appearance post-operatively. The clinical evaluator has no access to surgical records during 3- and 9-month follow-ups, and patients are instructed not to disclose their procedure type. The data analyst remains blinded until completion of statistical analyses. N/A Anterior Cruciate Ligament Injury. Intervention 1: Intervention group: Group undergoing Kaplan Tendonectomy after ACL reconstruction. For distal Kaplan tenodesis surgery, a 10-centimeter incision is made on the distal and lateral aspect of the thigh, at the mid-portion of the iliotibial band (ITB), with a slight inclination toward Gerdy’s tubercle. Then, a 10 × 1 centimeter strip of the ITB is incised. The proximal portion is detached, while the distal portion remains attached to the tibia at Gerdy’s tubercle.After preparing the graft, an appropriate reamer is used to create a tunnel in the femur. Finally, the graft is passed over the lateral collateral ligament (LCL), preserving the superior lateral genicular artery, and tenodesis of the graft is performed at 90 degrees of knee flexion and in a neutral rotation position. Intervention 2: Control group: Group undergoing ACL reconstruction only (Without Kaplan Tenodesis). No - There is not a plan to make this available Justification or reason for not sharing IPD is No decision yet
public Mohammadreza Razzaghof
No.17, Sheybani Alley, North Jamalzadeh Street
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 0196 m.razzaghof@gmail.com Tehran University of Medical Sciences scientific Mohammadreza Razzaghof
No.17, Sheybani Alley, North Jamalzadeh Street
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 0196 m-razzaghof@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adult patients aged 18 to 55 years Anterior Cruciate Ligament (ACL) injuries that are eligible for surgery 18 years 55 years Both Anterior Cruciate Ligament (ACL) revision surgery need for bilateral ACL reconstruction surgery patients requiring simultaneous repair or reconstruction of the posterior cruciate ligament and medial or lateral collateral ligament, patients with symptomatic articular cartilage defects requiring surgery beyond debridement, and an unhealthy lateral meniscus patients requiring simultaneous osteotomy patients whose contralateral knee is positive for any of the tests including the Anterior Drower test, Posterior Drower test, Lachman test, Pivot shift test, and rotational stability tests that raise suspicion of ligament damage S83.51 Sprain of anterior cruciate ligament of knee Treatment - Surgery Treatment - Surgery Intervention group: Group undergoing Kaplan Tendonectomy after ACL reconstruction. For distal Kaplan tenodesis surgery, a 10-centimeter incision is made on the distal and lateral aspect of the thigh, at the mid-portion of the iliotibial band (ITB), with a slight inclination toward Gerdy’s tubercle. Then, a 10 × 1 centimeter strip of the ITB is incised. The proximal portion is detached, while the distal portion remains attached to the tibia at Gerdy’s tubercle.After preparing the graft, an appropriate reamer is used to create a tunnel in the femur. Finally, the graft is passed over the lateral collateral ligament (LCL), preserving the superior lateral genicular artery, and tenodesis of the graft is performed at 90 degrees of knee flexion and in a neutral rotation position. Control group: Group undergoing ACL reconstruction only (Without Kaplan Tenodesis) The amount of anterior tibial displacement. Timepoint: 3 months and 9 months after surgery. Method of measurement: Lachman test. Rotational stability of the knee joint. Timepoint: 3 months and 9 months after surgery. Method of measurement: pivot shift test. The lysholm questionnaire score. Timepoint: 3 months and 9 months after surgery. Method of measurement: Lysholm knee questionnaire. IKDC (International Knee Documentation Committee) score. Timepoint: 3 months and 9 months after surgery. Method of measurement: International Knee Documentation Committee (IKDC) Questionnaire. Tegner Activity Scale (TAS) score. Timepoint: 3 months and 9 months after surgery. Method of measurement: Tanger Activity Score Questionnaire. VAS (Visual Analogue Scale) score. Timepoint: 3 months and 9 months after surgery. Method of measurement: Visual Analog Scale (VAS) questionnaire. The exact amount of anterior tibial displacement based on the KT-1000 test grade. Timepoint: 3 months and 9 months after surgery. Method of measurement: KT1000 Arthrometer. The need for reoperation. Timepoint: 3 months and 9 months after surgery. Method of measurement: Surgeon Evaluation and Examination. Tehran University of Medical Sciences Approved 2025-05-20 Ethics committee of Imam Khomeini Hospital Complex/ Tehran University of Medical Sciences Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway Tehran Tehran Iran (Islamic Republic of)