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Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps

Primary Purpose

Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Hamstring
Quadriceps tendon
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring ANTERIOR CRUCIATE LIGAMENT, INJURY, HAMSTRING, AUTOGRAFT, QUADRICEPS

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Facultad de Medicina UANL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hamstring

Quadriceps tendon

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

IKDC subjective score
International Knee Documentation Committee Subjective Knee Form (IKDC) assess patients with a variety of knee disorders including ligamentous and meniscal injuries as well as patellofemoral pain and osteoarthritis. 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
SF-12 physical domain
The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
SF-12 mental domain
The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
Flexion (degrees)
Range of motion in degrees
Extension (degrees)
Range of motion in degrees
Thigh circumference (cm)
Circumference (cm)

Full Information

First Posted
March 10, 2017
Last Updated
October 22, 2019
Sponsor
Universidad Autonoma de Nuevo Leon
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1. Study Identification

Unique Protocol Identification Number
NCT04137250
Brief Title
Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps
Official Title
Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps Tendon Autograft
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 27, 2016 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Nuevo Leon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
Keywords
ANTERIOR CRUCIATE LIGAMENT, INJURY, HAMSTRING, AUTOGRAFT, QUADRICEPS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hamstring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quadriceps tendon
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hamstring
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Quadriceps tendon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lysholm knee score
Description
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.
Time Frame
up to 12 months (Baseline and 12 months)
Secondary Outcome Measure Information:
Title
IKDC subjective score
Description
International Knee Documentation Committee Subjective Knee Form (IKDC) assess patients with a variety of knee disorders including ligamentous and meniscal injuries as well as patellofemoral pain and osteoarthritis. 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time Frame
up to 12 months (Baseline and 12 months)
Title
SF-12 physical domain
Description
The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
Time Frame
up to 12 months (Baseline and 12 months)
Title
SF-12 mental domain
Description
The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
Time Frame
up to 12 months (Baseline and 12 months)
Title
Flexion (degrees)
Description
Range of motion in degrees
Time Frame
up to 12 months (Baseline and 12 months)
Title
Extension (degrees)
Description
Range of motion in degrees
Time Frame
up to 12 months (Baseline and 12 months)
Title
Thigh circumference (cm)
Description
Circumference (cm)
Time Frame
up to 12 months (Baseline and 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Vilchez, PhD
Organizational Affiliation
UANL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Medicina UANL
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
1-4469
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25667401
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.
Results Reference
background
PubMed Identifier
18611995
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.
Results Reference
background
PubMed Identifier
6699049
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.
Results Reference
background
PubMed Identifier
1867330
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.
Results Reference
background

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Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps

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