Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction

ACL Injury Clinical Trial

Official title:

Examining Anterior Cruciate Ligament Reconstruction With Quadriceps- vs. Semitendinosus Tendon Graft for Young Federated Male Football Players.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06167343
• Other study ID #: CRUZADO23
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 20, 2025

Study information

• Verified date: January 2024
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: December 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL
• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences	Granada	Granada1

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Hospital Vithas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb strength	assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)	Participants will be followed over 24 months
Primary	Horizontal hop test	assessed by horizontal jump with one leg and hands on the waist, measured with a centimetric tape (three jumping opportunities)	Participants will be followed over 24 months
Secondary	Self-reported functionality	assessed by Tegner Lysholm Knee Scoring Scale and Modified Cincinnati Rating System Questionnaire (Spanish version)	Participants will be followed over 24 months
Secondary	Knee pain	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.	Participants will be followed over 24 months
Secondary	Pressure pain threshold	Using a digital algometer in epicondyle, vastus lateralis, vastus medialis and quadricipitalis tendon, patellar tendon, and insertion of the semitendinous tendon	Participants will be followed over 24 months
Secondary	Tendon ultrasound	it will monitor the morphology of the tendon and their surgical gap using ultrasound (Samsung HM70A echograph and Samsung Phased Array PE2-4 probe)	Participants will be followed over 24 months
Secondary	Perimeters	measured with the volume of both legs (injured and uninjured) using the mid-thigh circumference.	Participants will be followed over 24 months