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Not yet recruiting NCT07722104

Graft Type and Outcomes After ACL Reconstruction in Female Athletes

— Observational Anterior Cruciate Ligament Injuries Knee Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hamstring tendon autograft ACL reconstruction, Quadriceps tendon autograft ACL reconstruction.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injuries, Knee Injuries. Basic parameters: 16 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
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Official title

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

Overview

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.

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.

Interventions

  • Procedure Hamstring tendon autograft ACL reconstruction
    ACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique
  • Procedure Quadriceps tendon autograft ACL reconstruction
    ACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique

Primary outcome measures

  • Graft failure rate [Time frame: 24 months after surgery]
Secondary outcome measures (6)
  • return to sport rate [Time frame: 12 and 24 months after surgery]
  • IKDC Subjective knee Evaluation Form [Time frame: 6, 12 and 24 months after surgery]
  • KOOS (Knee Injury and Osteoarthritis outcome Score) [Time frame: 6, 12 and 24 months after surgery]
  • Lysholm Knee Scoring Scale [Time frame: 6, 12 and 24 months after surgery]
  • Limb Symetry Index (LSI) [Time frame: 6, 12 and 24 months after surgery]
  • Re-injury rate [Time frame: 24 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • IMED Hospitales — Alicante

Identifiers

NCT: NCT07722104 · IMED-LCA-HT-QT-2026 · CE042605

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗