Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction

NCT ID: NCT06167343

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-20

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.

Conditions

ACL; ACL Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Semitendinosus tendon graft

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.

Group Type: EXPERIMENTAL

ACL reconstruction

Intervention Type: PROCEDURE

In addition to surgical reconstruction, any structures that may have been injured concomitantly (meniscus, other ligament) will be repaired in the same surgery.

Quadriceps tendon graft

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

Group Type: EXPERIMENTAL

ACL reconstruction

Intervention Type: PROCEDURE

In addition to surgical reconstruction, any structures that may have been injured concomitantly (meniscus, other ligament) will be repaired in the same surgery.

Interventions

ACL reconstruction

In addition to surgical reconstruction, any structures that may have been injured concomitantly (meniscus, other ligament) will be repaired in the same surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Vithas

UNKNOWN

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Maria Lopez-Garzon

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Health Sciences

Granada, Granada, Spain

Countries

Spain

Other Identifiers

CRUZADO23

Identifier Type: -

Identifier Source: org_study_id