ClinicalTrials.gg
Not yet recruitingNCT07722104LCA-WOMENUpdated Jul 23, 2026

Graft Type and Outcomes After ACL Reconstruction in Female Athletes

An observational study in Anterior Cruciate Ligament Injuries and Knee Injuries, sponsored by Universidad Católica San Antonio de Murcia. Not yet recruiting at 1 site in Spain. Open to female participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Universidad Católica San Antonio de Murcia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
82
Ages
16 Years to 35 Years
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

  • Anterior Cruciate Ligament Injuries
  • Knee Injuries

Keywords

  • ACL reconstruction
  • hamstring tendon
  • quadriceps tendon
  • female athletes
  • autograft
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In context

Anterior Cruciate Ligament Injuries

625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.

This study's planned enrollment of 82 is below the median of 98 across 153 observational studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 138 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
82 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hamstring tendon autograft

    Female athletes undergoing ACL reconstruction with hamstring tendon autograft

    Procedure: Hamstring tendon autograft ACL reconstruction

  • Quadriceps tendon autograft

    Female athletes undergoing ACL reconstruction with quadriceps tendon autograft

    Procedure: Quadriceps tendon autograft ACL reconstruction

Interventions

  • ProcedureHamstring tendon autograft ACL reconstruction

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

  • ProcedureQuadriceps tendon autograft ACL reconstruction

    ACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique

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What researchers measure

Primary outcomes

  1. Graft failure rate

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

    Time frame: 24 months after surgery

Secondary outcomes

  1. return to sport rate

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

    Time frame: 12 and 24 months after surgery

  2. IKDC Subjective knee Evaluation Form

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

    Time frame: 6, 12 and 24 months after surgery

  3. 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

    Time frame: 6, 12 and 24 months after surgery

  4. Lysholm Knee Scoring Scale

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

    Time frame: 6, 12 and 24 months after surgery

  5. Limb Symetry Index (LSI)

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

    Time frame: 6, 12 and 24 months after surgery

  6. Re-injury rate

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

    Time frame: 24 months after surgery

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07722104
Responsible party
Luis Gutiérrez Sánchez (PhD Student, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Jul 23, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Aug 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Jul 23, 2026

Study contacts

Luis Gutiérrez Sánchez, MD
Contact
luis_gutierrez_sanchez@hotmail.com
625733811

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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