ACL, ACL Injury
Conditions
Brief summary
To investigate the differences between the two methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for young federated male football players. After surgery with quadricipital tendon graft or semitendinosus tendon graft, a two-year follow-up and the rate of return to sport are proposed.
Detailed description
The anterior cruciate ligament is one of the most common traumatic injuries in football, and surgery is proposed to restore knee stability. However, following surgery, few studies have focused on functional recovery of the knee with a wide arsenal of physical tests. Therefore, this study aims to study the efficacy for young football players of two types of grafts based on the most common tendons, the quadricipital and the semitendinosus (without the semimembranosus). Follow-ups will be performed at three months, six months, one year and two years after reconstruction. The variables measured will be isokinetic strength of flexors and extensors, unipodal jump test, self-perceived function, pain and tendon architecture with ultrasound.
Interventions
PROCEDUREACL reconstruction
In addition to surgical reconstruction, any structures that may have been injured concomitantly (meniscus, other ligament) will be repaired in the same surgery.
Sponsors
Universidad de Granada
Hospital Vithas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
14 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed anterior cruciate ligament rupture by MRI. * Prognosis of anterior cruciate ligament reconstruction surgery. * Be a registered or recreational football player.
Exclusion criteria
* Previous knee surgery. * Having articular cartilage lesions of Outerbridge grade greater than III-IV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower limb strength | Participants will be followed over 24 months | assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM) |
| Horizontal hop test | Participants will be followed over 24 months | assessed by horizontal jump with one leg and hands on the waist, measured with a centimetric tape (three jumping opportunities) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported functionality | Participants will be followed over 24 months | assessed by Tegner Lysholm Knee Scoring Scale and Modified Cincinnati Rating System Questionnaire (Spanish version) |
| Knee pain | Participants will be followed over 24 months | assessed by Visual Analogue Scale (VAS) for knee pain. The subjective perception of pain from 0 to 10 will be registered. Higher scores mean a worse outcome. |
| Pressure pain threshold | Participants will be followed over 24 months | Using a digital algometer in epicondyle, vastus lateralis, vastus medialis and quadricipitalis tendon, patellar tendon, and insertion of the semitendinous tendon |
| Tendon ultrasound | Participants will be followed over 24 months | it will monitor the morphology of the tendon and their surgical gap using ultrasound (Samsung HM70A echograph and Samsung Phased Array PE2-4 probe) |
| Perimeters | Participants will be followed over 24 months | measured with the volume of both legs (injured and uninjured) using the mid-thigh circumference. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORManuel Arroyo-Morales, PhD PT, MD
Universidad de Granada
Outcome results
None listed