Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
Study NCT ID:
NCT04137250
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2017-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps
Sponsor:
Universidad Autonoma de Nuevo Leon
Organization:
Study Overview
Official Title:
Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps Tendon Autograft
Status:
COMPLETED
Status Verified Date:
2019-10
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:
The use of hamstrings and quadriceps autografts as an alternative option for reconstruction of the anterior cruciate ligament has good clinical results: however, both techniques have not been compared among them, which is why this study is intended. The use of quadriceps tendon autograft in anterior cruciate ligament repair presents similar or better results compared to autograft of the hamstrings. The objective of the study is to compare the clinical effectiveness of anterior cruciate ligament reconstruction between the use of quadriceps tendon autograft versus hamstring autograft.
Detailed Description:
Methods Institution Patients attending the Orthopedics and Traumatology consult of the Hospital Universitario "Dr. Jose Eleuterio Gonzalez" of the Universidad Autonoma de Nuevo Leon.
Study design This is a double-blind , prospective, reproducible, comparative and longitudinal clinical trial with specific population.
It is proposed to study 28 patients, being randomly divided into two groups. Inclusion criteria: patients of age between 18 years and 45 years, with anterior cruciate ligament (ACL) injury diagnosed clinically and by magnetic resonance image and with or without associated meniscal injury, without previous reconstruction surgery and with previous informed Consent.
Exclusion criteria: multiligamentous injury and/or diagnosis of moderate or severe ostearthritis, chronic degenerative diseases (diabetes mellitus, hypertension) and contralateral ACL injury.
Elimination criteria: own initiative to stop participating and those who didn't complete all follow-up appointments.
Procedure Before surgery Detailed Informed Consent is performed to the patient before inclusion to the protocol Tegner Lysholm Knee Scoring Scale (evaluates the functionality of the knee and classifies them in grades with respect to its functional capacity) IKDC (evaluates knee ligament injuries, based on symptoms, sports activities and knee function) KOOS (evaluates knee sports injuries in young and middle-aged patients) Knee Society Score (pain, range of motion and injured knee stability) Cincinnati Knee Ligament Rating System (CKRS, assesses knee instability in ACL sports injuries) SF-12 (assesses patient's life quality) VAS (a subjective assesment of pain). Surgery The investigators will proceed to perform the anterior cruciate ligament reconstruction, both by the same surgeon, who will use the same technique in both groups, with the autograft in which the patient will have been randomly assigned.
After surgery all patients will be discharged previous warning signs explanation and several appointments in 2 weeks, 1 month, 3, 6 and 12 months after the procedure, for later evaluation scales, mentioned previously Statistical analysis In the sample size calculation, 14 patients per group are included using a mean equivalence formula, with 95% confidence and a power of 80%, estimating an equivalence of more less 2.5 on the Lysholm scale.
Study design This is a double-blind , prospective, reproducible, comparative and longitudinal clinical trial with specific population.
It is proposed to study 28 patients, being randomly divided into two groups. Inclusion criteria: patients of age between 18 years and 45 years, with anterior cruciate ligament (ACL) injury diagnosed clinically and by magnetic resonance image and with or without associated meniscal injury, without previous reconstruction surgery and with previous informed Consent.
Exclusion criteria: multiligamentous injury and/or diagnosis of moderate or severe ostearthritis, chronic degenerative diseases (diabetes mellitus, hypertension) and contralateral ACL injury.
Elimination criteria: own initiative to stop participating and those who didn't complete all follow-up appointments.
Procedure Before surgery Detailed Informed Consent is performed to the patient before inclusion to the protocol Tegner Lysholm Knee Scoring Scale (evaluates the functionality of the knee and classifies them in grades with respect to its functional capacity) IKDC (evaluates knee ligament injuries, based on symptoms, sports activities and knee function) KOOS (evaluates knee sports injuries in young and middle-aged patients) Knee Society Score (pain, range of motion and injured knee stability) Cincinnati Knee Ligament Rating System (CKRS, assesses knee instability in ACL sports injuries) SF-12 (assesses patient's life quality) VAS (a subjective assesment of pain). Surgery The investigators will proceed to perform the anterior cruciate ligament reconstruction, both by the same surgeon, who will use the same technique in both groups, with the autograft in which the patient will have been randomly assigned.
After surgery all patients will be discharged previous warning signs explanation and several appointments in 2 weeks, 1 month, 3, 6 and 12 months after the procedure, for later evaluation scales, mentioned previously Statistical analysis In the sample size calculation, 14 patients per group are included using a mean equivalence formula, with 95% confidence and a power of 80%, estimating an equivalence of more less 2.5 on the Lysholm scale.
Study Oversight
Has Oversight DMC:
True
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?: