Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps

NCT04137250 | Completed DMC

• 1 other identifier: OR16-00008
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture

Keywords

ANTERIOR CRUCIATE LIGAMENT; INJURY; HAMSTRING; AUTOGRAFT; QUADRICEPS

Outcome Measures

Primary Outcomes (1)

• Lysholm knee score

  Assessment tool for the results of ACL reconstruction even though it only measures activities of daily living. Higher scores indicate a better outcome with fewer symptoms or disability.

  up to 12 months (Baseline and 12 months)

Secondary Outcomes (6)

• IKDC subjective score

  up to 12 months (Baseline and 12 months)

• SF-12 physical domain

  up to 12 months (Baseline and 12 months)

• SF-12 mental domain

  up to 12 months (Baseline and 12 months)

• Flexion (degrees)

  up to 12 months (Baseline and 12 months)

• Extension (degrees)

  up to 12 months (Baseline and 12 months)

Study Arms (2)

Hamstring

ACTIVE COMPARATOR

It is the group in which the hamstrings are surgically removed to be used as an autograft for the reconstruction of the anterior cruciate ligament. The intervention will consist of make an incision on the medial side of the proximal portion of the leg approximately 3 centimeters to dissect by planes until the tendons of the hamstrings are located, which will be removed surgically with specialized instruments and the wound will be closed, for later These tendons be used as an autograft for the reconstruction of the anterior cruciate ligament.

Procedure: Hamstring

Quadriceps tendon

EXPERIMENTAL

It is the group in which a portion of the quadriceps tendon will be surgically removed for later use as an autograft for the reconstruction of the anterior cruciate ligament. The intervention consisted in making an incision in the anterior aspect of the distal portion of the thigh of approximately 3 centimeters to dissect by planes until locating the membranous portion of the quadriceps tendon, from which will be removed a portion of surgical way with specialized instruments and the Wound will be closed, for later this tendon to be used as an autograft for the reconstruction of the anterior cruciate ligament.

Procedure: Quadriceps tendon

Interventions

Hamstring PROCEDURE

The intervention will consist of make an incision on the medial side of the proximal portion of the leg approximately 3 centimeters to dissect by planes until the tendons of the hamstrings are located, which will be removed surgically with specialized instruments and the wound will be closed, for later These tendons be used as an autograft for the reconstruction of the anterior cruciate ligament

Hamstring

Quadriceps tendon PROCEDURE

orThe intervention consisted in making an incision in the anterior aspect of the distal portion of the thigh of approximately 3 centimeters to dissect by planes until locating the membranous portion of the quadriceps tendon, from which will be removed a portion of surgical way with specialized instruments and the Wound will be closed, for later this tendon to be used as an autograft for the reconstruction of the anterior cruciate ligament.

Quadriceps tendon

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Facultad de Medicina UANL

Monterrey, Nuevo León, 1-4469, Mexico

Location

Related Publications (4)

• 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.

  PMID: 25667401 BACKGROUND

• 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.

  PMID: 18611995 BACKGROUND

• 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.

  PMID: 6699049 BACKGROUND

• 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.

  PMID: 1867330 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries

Study Officials

• Felix Vilchez, PhD

  UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics and Traumatology

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: October 23, 2019
• Study Start: July 27, 2016
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

ME (1)