Graft Type and Outcomes After ACL Reconstruction in Female Athletes (LCA-WOMEN)

Influence of Graft Type on Functional and Neuromuscular Outcomes After Anterior Cruciate Ligament Reconstruction in Female Athletes: A Prospective Multicenter Cohort Study

This prospective multicenter cohort study aims to compare clinical and functional outcomes between hamstring tendon and quadriceps tendon autografts in anterior cruciate ligament (ACL) reconstruction in female athletes. Participants will be followed for two years after surgery to evaluate graft failure rates, return to sport, knee stability, and patient-reported outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Knee Injuries
• Intervention / Treatment: Procedure: Hamstring tendon autograft ACL reconstruction; Procedure: Quadriceps tendon autograft ACL reconstruction

Detailed Description

Anterior cruciate ligament injuries are particularly prevalent in female athletes and represent a major challenge in sports medicine. The choice of graft type in ACL reconstruction may influence clinical outcomes, yet evidence specifically in female populations remains limited. This study prospectively enrolls female athletes undergoing ACL reconstruction with either hamstring tendon or quadriceps tendon autograft across multiple centers in Spain. Primary outcome is graft failure rate at 24 months. Secondary outcomes include return to sport rate, IKDC score, KOOS, Lysholm scale, limb symmetry index, and re-injury rate. Data will be collected preoperatively and at 6, 12, and 24 months postoperatively.

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

• Study Contact: Name: Luis Gutiérrez Sánchez, MD; Phone Number: 625733811; Email: luis_gutierrez_sanchez@hotmail.com

Study Locations

• Spain
  • Alicante
    • Alicante, Alicante, Spain, 03540
      • IMED Hospitales
      • Contact: Luis Gutiérrez Sánchez, MD; Phone Number: +34625733811; Email: luis_gutierrez_sanchez@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female athletes aged 16 to 35 years undergoing primary ACL reconstruction with either hamstring tendon or quadriceps tendon autograft across multiple sports medicine centers in Spain.

Description

Inclusion Criteria:

• Female patients aged 16 to 35 years with skeletal maturity
• Active athlete: minimum two training sessions per week during the six months prior to injury in pivoting sports
• Confirmed complete ACL rupture by MRI and clinical examination
• Primary ACL reconstruction (first ligament surgery on the index knee)
• Time from injury to surgery no longer than 6 months
• Signed informed consent

Exclusion Criteria:

• Previous ligament surgery on either knee
• Multiligament injury: simultaneous PCL, grade III MCL or LCL injury
• Neuromuscular, rheumatological or systemic pathology interfering with rehabilitation or functional assessments
• Pre-existing radiological osteoarthritis grade Kellgren-Lawrence ≥2 in the index knee
• Inability to complete 24-month follow-up protocol
• Pregnancy at inclusion or during follow-up period

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hamstring tendon autograft; Female athletes undergoing ACL reconstruction with hamstring tendon autograft	Procedure: Hamstring tendon autograft ACL reconstruction; ACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique
Quadriceps tendon autograft; Female athletes undergoing ACL reconstruction with quadriceps tendon autograft	Procedure: Quadriceps tendon autograft ACL reconstruction; ACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure rate	Proportion of patients requiring revision ACL reconstruction or presenting with objetive graft rupture confirmed by MRI or arthroscopy	24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
return to sport rate	proportion of athletes who returned to their pre-injury sport level, assessed by athlete and surgeon	12 and 24 months after surgery
IKDC Subjective knee Evaluation Form	Patient-reported outcomes measure assessing knee symptoms, function and sports activity.	6, 12 and 24 months after surgery
KOOS (Knee Injury and Osteoarthritis outcome Score)	Patient-reported outcome measure assessing pain, symptoms, function in daily living, function in sport and recreation, and knee-related quality of life	6, 12 and 24 months after surgery
Lysholm Knee Scoring Scale	Clinician-reported outcome measure assessing knee function including pain, instability, locking, swelling, stair climbing, squatting and limp	6, 12 and 24 months after surgery
Limb Symetry Index (LSI)	Assessed vy isokinetic dynamometry and single-leg hop tests to evaluate quadriceps and hamstring strength symmetry between limbs	6, 12 and 24 months after surgery
Re-injury rate	Proportion of patients sustaining a new ipsilateral or contralateral ACL injury during the follow-up period.	24 months after surgery

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 19, 2026
• First Submitted That Met QC Criteria: July 19, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: ACL reconstruction; quadriceps tendon; autograft; female athletes; hamstring tendon
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: IMED-LCA-HT-QT-2026; CE042605 (Other Identifier: Comite de Etica de la UCAM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No