Anterior Cruciate Ligament Injury
Conditions
Brief summary
Randomized controlled trial comparing reconstruction of anterior cruciate ligament (ACL) with autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. It is intended to specially evaluate if by using only the semitendinosus (ST) tendon, the strength of the limb for hamstrings is affected different compared to using both gracilis and ST.
Detailed description
Data checks programmed by a third party after inclusion of participant number 10, 20, 30 and 42. This includes source data verification. Simple size calculations estimating a difference of 50% in strength improvement between both groups at the six months follow-up visit. 80% power and 5% alpha error. Strength measured with dynamometer, laxity with ACL laxity tester and function with 3 scores: IKDC, Tegner-Lysholm and KOOS. Missing data will be minimized by double checking when registering data. It might be necessary to increase sample size to 50 patients of intermediate analysis show it is necessary to find an statistically significant difference. Trial could be stopped early if one intervention shows to be better in the intermediate analysis. These analysis will be conducted after the first 16 and 32 participants have been included.
Interventions
PROCEDUREQuadrupled semitendinosus graft
Quadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
PROCEDUREST-Gracilis graft
Use of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
Sponsors
Fundacion Clinica Valle del Lili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. They should be at least 16 years old.
Exclusion criteria
* Multiligament injuries. Re-ruptures of the ACL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamstrings Strength | 6 months | Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior cruciate ligament rerupture | 24 months | New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination. |
| ACL laxity | 24 months | Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz). |
Countries
Colombia
Outcome results
None listed