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Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction

U

University of Granada (UGR)

Status

Active, not recruiting

Conditions

ACL
ACL Injury

Treatments

Procedure: ACL reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT06167343
CRUZADO23

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

Male

Ages

14 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 2 patient groups

Semitendinosus tendon graft
Experimental group
Description:
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.
Treatment:
Procedure: ACL reconstruction
Quadriceps tendon graft
Experimental group
Description:
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
Treatment:
Procedure: ACL reconstruction

Trial contacts and locations

1

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Central trial contact

Maria Lopez-Garzon, PhD Physical therapist

Data sourced from clinicaltrials.gov

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