Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction

Not Applicable

Active, not recruiting

• Conditions: ACL Injury; ACL
• Interventions: Procedure: ACL reconstruction

• Registration Number: NCT06167343
• Lead Sponsor: Universidad de Granada

Brief Summary

To investigate the differences between the two methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for young federated male football players. After surgery with quadricipital tendon graft or semitendinosus tendon graft, a two-year follow-up and the rate of return to sport are proposed.

Detailed Description

The anterior cruciate ligament is one of the most common traumatic injuries in football, and surgery is proposed to restore knee stability. However, following surgery, few studies have focused on functional recovery of the knee with a wide arsenal of physical tests. Therefore, this study aims to study the efficacy for young football players of two types of grafts based on the most common tendons, the quadricipital and the semitendinosus (without the semimembranosus). Follow-ups will be performed at three months, six months, one year and two years after reconstruction. The variables measured will be isokinetic strength of flexors and extensors, unipodal jump test, self-perceived function, pain and tendon architecture with ultrasound.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-09-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

• Confirmed anterior cruciate ligament rupture by MRI.
• Prognosis of anterior cruciate ligament reconstruction surgery.
• Be a registered or recreational football player.

Exclusion Criteria

• Previous knee surgery.
• Having articular cartilage lesions of Outerbridge grade greater than III-IV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadriceps tendon graft	ACL reconstruction	Surgical reconstruction of primary ACL rupture with autograft harvested from the quadriceps tendon (QT) without bone block. The QT graft is harvested through a 4-5 cm incision at the upper pole of the patella. A graft sized 10-12 mm in with and app. 6 mm in depth is harvested from the middle part of the tendon. The femoral tunnel is placed anatomically central in the native footprint of the ACL. The tibia tunnel is also placed anatomically; the center of the tunnel being medially between the eminential spines at the level of the posterior margin of the anterior horn of the lateral meniscus. The QT graft is fixed proximally with the RIGIDLOOP® adjustable cortical system (DePuy Synthes) and distally with the RIGIDLOOP® XL adjustable cortical system
Semitendinosus tendon graft	ACL reconstruction	Surgical reconstruction of primary ACL rupture with autograft harvested from the semitendinosus tendon (ST). The ST graft is harvested through a 4-5 cm incision at the pes anserinus. The semitendinosus is identified and harvested. The tendon is prepared and folded to a four-stranded graft with a total diameter of 8-11 mm. The femoral tunnel is placed anatomically central in the native footprint of the ACL. The tibia tunnel is also placed anatomically; the center of the tunnel being medially between the eminential spines at the level of the posterior margin of the anterior horn of the lateral meniscus. The quadrupled ST graft is fixed proximally with the RIGIDLOOP® adjustable cortical system (DePuy Synthes) and distally with the RIGIDLOOP® XL adjustable cortical system.

Primary Outcome Measures

Name	Time	Method
Lower limb strength	Participants will be followed over 24 months	assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)
Horizontal hop test	Participants will be followed over 24 months	assessed by horizontal jump with one leg and hands on the waist, measured with a centimetric tape (three jumping opportunities)

Secondary Outcome Measures

Name	Time	Method
Perimeters	Participants will be followed over 24 months	measured with the volume of both legs (injured and uninjured) using the mid-thigh circumference.
Self-reported functionality	Participants will be followed over 24 months	assessed by Tegner Lysholm Knee Scoring Scale and Modified Cincinnati Rating System Questionnaire (Spanish version)
Knee pain	Participants will be followed over 24 months	assessed by Visual Analogue Scale (VAS) for knee pain. The subjective perception of pain from 0 to 10 will be registered. Higher scores mean a worse outcome.
Pressure pain threshold	Participants will be followed over 24 months	Using a digital algometer in epicondyle, vastus lateralis, vastus medialis and quadricipitalis tendon, patellar tendon, and insertion of the semitendinous tendon
Tendon ultrasound	Participants will be followed over 24 months	it will monitor the morphology of the tendon and their surgical gap using ultrasound (Samsung HM70A echograph and Samsung Phased Array PE2-4 probe)

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇪🇸 Granada, Spain