NCT06167343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

December 4, 2023

Last Update Submit

April 30, 2026

Conditions

ACLACL Injury

Outcome Measures

Primary Outcomes (2)

  • Lower limb strength

    assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)

    Participants will be followed over 24 months

  • 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 Outcomes (5)

  • Self-reported functionality

    Participants will be followed over 24 months

  • Knee pain

    Participants will be followed over 24 months

  • Pressure pain threshold

    Participants will be followed over 24 months

  • Tendon ultrasound

    Participants will be followed over 24 months

  • Perimeters

    Participants will be followed over 24 months

Study Arms (2)

Semitendinosus tendon graft

EXPERIMENTAL

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.

Procedure: ACL reconstruction

Quadriceps tendon graft

EXPERIMENTAL

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

Procedure: ACL reconstruction

Interventions

ACL reconstructionPROCEDURE

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 graftSemitendinosus tendon graft

Eligibility Criteria

Age14 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Manuel Arroyo-Morales, PhD PT, MD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

October 1, 2023

Primary Completion

October 13, 2025

Study Completion

December 20, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

ES(1)