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Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps

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ClinicalTrials.gov Identifier: NCT04137250
Recruitment Status : Completed
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture Procedure: Hamstring Procedure: Quadriceps tendon Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps Tendon Autograft
Actual Study Start Date : July 27, 2016
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hamstring
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
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

Experimental: Quadriceps tendon
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
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 Measures :
  1. Lysholm knee score [ Time Frame: up to 12 months (Baseline and 12 months) ]
    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 :
  1. IKDC subjective score [ Time Frame: up to 12 months (Baseline and 12 months) ]
    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).

  2. SF-12 physical domain [ Time Frame: up to 12 months (Baseline and 12 months) ]

    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.


  3. SF-12 mental domain [ Time Frame: up to 12 months (Baseline and 12 months) ]

    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.


  4. Flexion (degrees) [ Time Frame: up to 12 months (Baseline and 12 months) ]
    Range of motion in degrees

  5. Extension (degrees) [ Time Frame: up to 12 months (Baseline and 12 months) ]
    Range of motion in degrees

  6. Thigh circumference (cm) [ Time Frame: up to 12 months (Baseline and 12 months) ]
    Circumference (cm)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137250


Locations
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Mexico
Facultad de Medicina UANL
Monterrey, Nuevo Leon, Mexico, 1-4469
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Felix Vilchez, PhD UANL

Publications:
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Responsible Party: FELIX VILCHEZ CAVAZOS, Professor of Orthopedics and Traumatology, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT04137250     History of Changes
Other Study ID Numbers: OR16-00008
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon:
ANTERIOR CRUCIATE LIGAMENT
INJURY
HAMSTRING
AUTOGRAFT
QUADRICEPS
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries