ACL Injury Clinical Trial
Official title:
Examining Anterior Cruciate Ligament Reconstruction With Quadriceps- vs. Semitendinosus Tendon Graft for Young Federated Male Football Players.
Verified date | January 2024 |
Source | Universidad de Granada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 54 |
Est. completion date | December 20, 2025 |
Est. primary completion date | September 20, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 14 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Health Sciences | Granada | Granada1 |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada | Hospital Vithas |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower limb strength | assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM) | Participants will be followed over 24 months | |
Primary | Horizontal hop test | assessed by horizontal jump with one leg and hands on the waist, measured with a centimetric tape (three jumping opportunities) | Participants will be followed over 24 months | |
Secondary | Self-reported functionality | assessed by Tegner Lysholm Knee Scoring Scale and Modified Cincinnati Rating System Questionnaire (Spanish version) | Participants will be followed over 24 months | |
Secondary | Knee pain | 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. | Participants will be followed over 24 months | |
Secondary | Pressure pain threshold | Using a digital algometer in epicondyle, vastus lateralis, vastus medialis and quadricipitalis tendon, patellar tendon, and insertion of the semitendinous tendon | Participants will be followed over 24 months | |
Secondary | Tendon ultrasound | it will monitor the morphology of the tendon and their surgical gap using ultrasound (Samsung HM70A echograph and Samsung Phased Array PE2-4 probe) | Participants will be followed over 24 months | |
Secondary | Perimeters | measured with the volume of both legs (injured and uninjured) using the mid-thigh circumference. | Participants will be followed over 24 months |
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