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Anterior Cruciate Ligament InjuryNCT04137250

Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps

A study testing Hamstring and Quadriceps tendon in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Hamstring and Quadriceps tendon
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteMexico
Study dates
27 Jul 2016to 20 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Facultad de Medicina UANL

    Monterrey, Nuevo León, 1-4469

Other trials in Mexico

About this study

Official title: Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps Tendon Autograft

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.

Read the 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.

Being tested
Hamstring, Quadriceps tendon
Keywords
ANTERIOR CRUCIATE LIGAMENT, INJURY, HAMSTRING, AUTOGRAFT, QUADRICEPS
Medical subject headings
Anterior Cruciate Ligament Injuries, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HamstringProcedure or surgery

    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

  • Quadriceps tendonProcedure or surgery

    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.

Study groups in NCT04137250
Study groupRoleWhat they receive
HamstringActive comparatorIt 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.
Receives: Procedure: Hamstring
Quadriceps tendonExperimentalIt 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.
Receives: Procedure: Quadriceps tendon

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 12 months (Baseline and 12 months)

Secondary outcomes (6)

  1. 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).

    Measured: up to 12 months (Baseline and 12 months)

  2. 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.

    Measured: up to 12 months (Baseline and 12 months)

  3. 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.

    Measured: up to 12 months (Baseline and 12 months)

  4. Flexion (degrees)

    Range of motion in degrees

    Measured: up to 12 months (Baseline and 12 months)

  5. Extension (degrees)

    Range of motion in degrees

    Measured: up to 12 months (Baseline and 12 months)

  6. Thigh circumference (cm)

    Circumference (cm)

    Measured: up to 12 months (Baseline and 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start27 Jul 2016
  3. Primary completion20 Feb 2018
  4. Study completion20 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04137250
Sponsor's protocol ID
OR16-00008
Status last verified
Oct 2019
First submitted
10 Mar 2017
Last updated
23 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25667401

  • 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.

    PubMed 18611995

  • 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.

    PubMed 6699049

  • 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.

    PubMed 1867330

Questions about this trial

What is this clinical trial studying?

A study testing Hamstring and Quadriceps tendon in people with Anterior Cruciate Ligament Injury and Anterior Cruciate Ligament Rupture, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lysholm knee score (time frame: up to 12 months (Baseline and 12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04137250, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.

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