Clinical trial NCT04137250: Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps
Official title: Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps Tendon Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
Keywords: ANTERIOR CRUCIATE LIGAMENT
INJURY
HAMSTRING
AUTOGRAFT
QUADRICEPS
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind clinical trial with specific population, prospective, reproducible, comparative and longitudinal.

It is proposed to study 28 patients, being randomly divided into two groups. We include patients of age between 18 years and 45 years, who have an anterior cruciate ligament injury diagnosed clinically and by image (magnetic resonance) and patients with or without associated meniscal injury, without previous reconstruction surgery and with previous informed Consent.

We exclude patients with multiligamentous injury and/or those who have diagnosis of moderate or severe ostearthritis, chronic degenerative diseases (diabetes mellitus, hypertension) and contralateral ACL injury.

We eliminate patients that for own initiative, wants to stop participating and those who didn't complete all follow-up appointments.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age between 18 years and 45 years
* Anterior cruciate ligament injury diagnosed clinically and by image (magnetic resonance)
* Patients with or without associated meniscal injury
* Patients without previous ACL reconstruction surgery
* Patients with previous informed Consent.

Exclusion Criteria:

* Patients with multiligamentous injury
* Patients who have diagnosis of moderate or severe ostearthritis
* Patients with chronic degenerative diseases (diabetes mellitus, hypertension)
* Patients with contralateral ACL injury.

Elimination criteria

* Patients that for own initiative, wants to stop participating
* Patients who didn't complete all follow-up appointments.

Primary outcomes:
measure: Lysholm knee score
timeFrame: up to 12 months (Baseline and 12 months)
Secondary outcomes:
measure: IKDC subjective score
timeFrame: up to 12 months (Baseline and 12 months)
measure: SF-12 physical domain
timeFrame: up to 12 months (Baseline and 12 months)
measure: SF-12 mental domain
timeFrame: up to 12 months (Baseline and 12 months)
measure: Flexion (degrees)
timeFrame: up to 12 months (Baseline and 12 months)
measure: Extension (degrees)
timeFrame: up to 12 months (Baseline and 12 months)
measure: Thigh circumference (cm)
timeFrame: up to 12 months (Baseline and 12 months)
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Facultad de Medicina UANL
state: Nuevo Leon
Study officials:
affiliation: UANL
name: Felix Vilchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lynch TS, Parker RD, Patel RM, Andrish JT; MOON Group; Spindler KP, Amendola A, Brophy RH, Dunn WR, Flanigan DC, Huston LJ, Jones MH, Kaeding CC, Marx RG, Matava MJ, McCarty EC, Pedroza AD, Reinke EK, Wolf BR, Wright RW. The Impact of the Multicenter Orthopaedic Outcomes Network (MOON) Research on Anterior Cruciate Ligament Reconstruction and Orthopaedic Practice. J Am Acad Orthop Surg. 2015 Mar;23(3):154-63. doi: 10.5435/JAAOS-D-14-00005. Epub 2015 Feb 9.
citation: Prodromos CC, Fu FH, Howell SM, Johnson DH, Lawhorn K. Controversies in soft-tissue anterior cruciate ligament reconstruction: grafts, bundles, tunnels, fixation, and harvest. J Am Acad Orthop Surg. 2008 Jul;16(7):376-84. doi: 10.5435/00124635-200807000-00003.
citation: Noyes FR, Butler DL, Grood ES, Zernicke RF, Hefzy MS. Biomechanical analysis of human ligament grafts used in knee-ligament repairs and reconstructions. J Bone Joint Surg Am. 1984 Mar;66(3):344-52.
citation: Woo SL, Hollis JM, Adams DJ, Lyon RM, Takai S. Tensile properties of the human femur-anterior cruciate ligament-tibia complex. The effects of specimen age and orientation. Am J Sports Med. 1991 May-Jun;19(3):217-25. doi: 10.1177/036354659101900303.