Anterior Cruciate Ligament InjuriesLCA-WOMENNCT07722104
Graft Type and Outcomes After ACL Reconstruction in Female Athletes
An observational study of Anterior Cruciate Ligament Injuries and Knee Injuries, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women only
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Knee Injuries
- What is being tested?
- Hamstring tendon autograft ACL reconstruction and Quadriceps tendon autograft ACL reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
IMED Hospitales
Alicante, Alicante, 03540
Luis Gutiérrez Sánchez, MD, +34625733811, luis_gutierrez_sanchez@hotmail.com
About this study
Official title: 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.
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.
- Conditions
- Anterior Cruciate Ligament Injuries, Knee Injuries
- Being tested
- Hamstring tendon autograft ACL reconstruction, Quadriceps tendon autograft ACL reconstruction
- Keywords
- ACL reconstruction, hamstring tendon, quadriceps tendon, female athletes, autograft
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamstring tendon autograft ACL reconstructionProcedure or surgery
ACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique
Quadriceps tendon autograft ACL reconstructionProcedure or surgery
ACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique
| Study group | Role | What they receive |
|---|---|---|
| Hamstring tendon autograft | Female athletes undergoing ACL reconstruction with hamstring tendon autograft Receives: Procedure: Hamstring tendon autograft ACL reconstruction | |
| Quadriceps tendon autograft | Female athletes undergoing ACL reconstruction with quadriceps tendon autograft Receives: Procedure: Quadriceps tendon autograft ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft failure rate
Proportion of patients requiring revision ACL reconstruction or presenting with objetive graft rupture confirmed by MRI or arthroscopy
Measured: 24 months after surgery
Secondary outcomes (6)
return to sport rate
proportion of athletes who returned to their pre-injury sport level, assessed by athlete and surgeon
Measured: 12 and 24 months after surgery
IKDC Subjective knee Evaluation Form
Patient-reported outcomes measure assessing knee symptoms, function and sports activity.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Gutiérrez Sánchez, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722104
- Sponsor's protocol ID
- IMED-LCA-HT-QT-2026
- Other IDs
- CE042605
- Acronym
- LCA-WOMEN
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Graft Type on Functional and Neuromuscular Outcomes After Anterior Cruciate Ligament Reconstruction in Female Athletes: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07722104
- Acronym / sponsor ID
- LCA-WOMEN / IMED-LCA-HT-QT-2026
- Conditions
- Anterior Cruciate Ligament Injuries, Knee Injuries
- Keywords
- ACL reconstruction, hamstring tendon, quadriceps tendon, female athletes, autograft
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hamstring tendon autograft | – | Procedure: Hamstring tendon autograft ACL reconstructionFemale athletes undergoing ACL reconstruction with hamstring tendon autograft |
| Quadriceps tendon autograft | – | Procedure: Quadriceps tendon autograft ACL reconstructionFemale athletes undergoing ACL reconstruction with quadriceps tendon autograft |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamstring tendon autograft ACL reconstructionACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique | Procedure or surgery | Hamstring tendon autograft |
| Quadriceps tendon autograft ACL reconstructionACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique | Procedure or surgery | Quadriceps tendon autograft |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Knee Injuries, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Gutiérrez Sánchez, MD (625733811, luis_gutierrez_sanchez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft failure rate (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.