Graft Type and Outcomes After ACL Reconstruction in Female Athletes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16-35
SponsorUniversidad Católica San Antonio de Murcia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hamstring tendon autograft ACL reconstruction
Procedure/SurgeryACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique
Quadriceps tendon autograft ACL reconstruction
Procedure/SurgeryACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Hamstring tendon autograft1 intervention
Group B: Quadriceps tendon autograft1 intervention
Trial outcomes
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 surgerySecondary 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 surgery2
IKDC Subjective knee Evaluation Form
Patient-reported outcomes measure assessing knee symptoms, function and sports activity.
Time frame
6, 12 and 24 months after surgery3
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 surgery4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: