- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137250
Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps
Arthroscopic ACL Reconstruction: Hamstring Versus Quadriceps Tendon Autograft
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 1-4469
- Facultad de Medicina UANL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 12 months (Baseline and 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
up to 12 months (Baseline and 12 months)
|
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. |
up to 12 months (Baseline and 12 months)
|
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. |
up to 12 months (Baseline and 12 months)
|
Flexion (degrees)
Time Frame: up to 12 months (Baseline and 12 months)
|
Range of motion in degrees
|
up to 12 months (Baseline and 12 months)
|
Extension (degrees)
Time Frame: up to 12 months (Baseline and 12 months)
|
Range of motion in degrees
|
up to 12 months (Baseline and 12 months)
|
Thigh circumference (cm)
Time Frame: up to 12 months (Baseline and 12 months)
|
Circumference (cm)
|
up to 12 months (Baseline and 12 months)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Felix Vilchez, PhD, UANL
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OR16-00008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Cruciate Ligament Rupture
-
Bezirkskrankenhaus SchwazNot yet recruitingAnterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament InjuryAustria
-
University of Colorado, DenverChildren's Hospital ColoradoRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearUnited States
-
Karolinska InstitutetRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearSweden
-
Rush University Medical CenterEnrolling by invitationAnterior Cruciate Ligament Rupture | Anterior Cruciate Ligament InjuryUnited States
-
Bahçeşehir UniversityIstanbul University - Cerrahpasa (IUC)CompletedAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearTurkey
-
Miach OrthopaedicsActive, not recruitingAnterior Cruciate Ligament Rupture | Anterior Cruciate Ligament InjuryUnited States
-
University of BathVersus ArthritisRecruitingPost-traumatic Osteoarthritis | Anterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Anterior Cruciate Ligament ReconstructionUnited Kingdom
-
Artromedical Konrad Malinowski ClinicRecruitingAnalysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch SignAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearPoland
-
Artromedical Konrad Malinowski ClinicRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearPoland
-
Liverpool University Hospitals NHS Foundation TrustRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearUnited Kingdom
Clinical Trials on Hamstring
-
Hvidovre University HospitalUniversity of Southern Denmark; AspetarCompletedRepeated-sprint AbilityDenmark
-
Yeditepe UniversityCompletedSports Physical Therapy | Sport Injury | Hamstring Injury | Injury; Back, Lower, SuperficialTurkey
-
Riphah International UniversityCompletedIntervention | Injury PreventionPakistan
-
Dublin City UniversityCompletedHamstring InjuryIreland
-
Riphah International UniversityCompleted
-
Sandro FucenteseActive, not recruitingACL | ACL Injury | ACL - Anterior Cruciate Ligament RuptureSwitzerland
-
Chinese University of Hong KongCompleted
-
Universidad de GranadaCompletedAcute Injury of Anterior Cruciate LigamentSpain
-
Cairo UniversityUnknown
-
University of JaenCompleted