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NCT Number: NCT07722104

Graft Type and Outcomes After ACL Reconstruction in Female Athletes

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

16 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hamstring tendon autograft ACL reconstruction

Procedure

ACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique

Quadriceps tendon autograft ACL reconstruction

Procedure

ACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique

Primary outcomes

  1. Graft failure rate

    Time frame: 24 months after surgery

    Proportion of patients requiring revision ACL reconstruction or presenting with objetive graft rupture confirmed by MRI or arthroscopy

Secondary outcomes

  1. return to sport rate

    Time frame: 12 and 24 months after surgery

    proportion of athletes who returned to their pre-injury sport level, assessed by athlete and surgeon

  2. IKDC Subjective knee Evaluation Form

    Time frame: 6, 12 and 24 months after surgery

    Patient-reported outcomes measure assessing knee symptoms, function and sports activity.

  3. KOOS (Knee Injury and Osteoarthritis outcome Score)

    Time frame: 6, 12 and 24 months after surgery

    Patient-reported outcome measure assessing pain, symptoms, function in daily living, function in sport and recreation, and knee-related quality of life

  4. Lysholm Knee Scoring Scale

    Time frame: 6, 12 and 24 months after surgery

    Clinician-reported outcome measure assessing knee function including pain, instability, locking, swelling, stair climbing, squatting and limp

  5. Limb Symetry Index (LSI)

    Time frame: 6, 12 and 24 months after surgery

    Assessed vy isokinetic dynamometry and single-leg hop tests to evaluate quadriceps and hamstring strength symmetry between limbs

  6. Re-injury rate

    Time frame: 24 months after surgery

    Proportion of patients sustaining a new ipsilateral or contralateral ACL injury during the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Gutiérrez Sánchez, MD

CONTACT

[email protected]

625733811

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: LCA-WOMEN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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