Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrupled semitendinosus graft | Experimental | Autologous quadrupled semitendinosus graft is used to reconstruct the ACL injury |
|
| ST-Gracilis graft | Active Comparator | Both gracilis and semitendinosus autologous graft are used to reconstruct the ACL injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrupled semitendinosus graft | Procedure | Quadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamstrings Strength | Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior cruciate ligament rerupture | New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination. | 24 months |
| ACL laxity | Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan P Martinez, MD | Fundacion Clinica Valle del Lili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Valle del Lili | Cali | Valle del Cauca Department | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41018256 | Derived | Martinez-Cano JP, Gallego A, Cuadros J, Ibarra L, Mejia FM, Velasquez-Hammerle MV, Martinez-Rondanelli A. Similar results with quadrupled semitendinosus and semitendinosus-gracilis graft in anterior cruciate ligament reconstruction: A randomised controlled trial with 2-year follow-up. J Exp Orthop. 2025 Sep 24;12(3):e70399. doi: 10.1002/jeo2.70399. eCollection 2025 Jul. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ST-Gracilis graft | Procedure | Use of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia. |
|
| 24 months |