Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03433170
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2018-01-27
Brief Title:
Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction
Sponsor:
Fundacion Clinica Valle del Lili
Organization:
Fundacion Clinica Valle del Lili
Study Overview
Official Title:
Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None