JUSTIFICATION ACL rupture is one of the most frequent and studied injuries in orthopedic
literature. Various short-, medium- and long-term results of ACL reconstruction have been
described in the international literature, as well as comparisons between different types of
reconstruction techniques, grafts and complications.
The vast majority of studies and clinical trials focus on BPTB and hamstrings tendon (HT),
the former being considered by multiple authors as the gold standard for the management of
these injuries despite its association with high donor site morbidity such as anterior knee
pain, pain when kneeling and muscle weakness.
With an adequate surgical technique for both graft harvesting and ACL reconstruction, the use
of QT as a graft has reported good biomechanical and clinical results and even superior to
other grafts. However, despite this, at present a precise justification has not been
established that defines the advantages or disadvantages of choosing this graft over other
popular techniques, which is why a randomized study was carried out in a center of high
specialty and concentration of patients with this type of lesions will increase the level of
scientific validation of the information available regarding the use of this graft.
PROBLEM STATEMENT Is there a statistically significant difference between both techniques
(BPTB and QT) at 2 years? Minimum follow-up regarding clinical evolution measured with IKDC,
objective stability measured by KT-1000, and adverse events in primary ACL reconstruction?
HYPOTHESIS In patients with anterior cruciate ligament (ACL) injury who undergo surgery
reconstruction with the use of autologous quadriceps tendon with bone plug (QT) or bone
patellar tendon bone (BPTB) graft, there will be no statistically significant difference
between them, in the first 2 years of follow-up, in terms of clinical evolution measured by
the International subjective scale Knee Documentation Committee (IKDC), nor objective
stability measured by arthrometry with the KT1000 device; In addition, there will be fewer
adverse events in patients in whom quadriceps tendon graft (QT) was used compared to bone
patellar tendon bone graft (BPTB).
GENERAL OBJECTIVE Observe if there is a statistically significant difference between both QT
and BPTB grafts in terms of clinical evolution measured by IKDC, and objective stability
measured by KT-1000, as well as reporting adverse events in both groups at 2 years of
follow-up.
MATERIAL AND METHODS Controlled, longitudinal, prospective, randomized, double-blind clinical
trial that will include patients from the Luis Guillermo Ibarra-Ibarra National
Rehabilitation Institute (INRLGII) of the Sports Orthopedics and Arthroscopy service, with
primary ACL injury who undergo surgery with a consistent procedure in ACL reconstruction
either with the use of bone patellar tendon bone graft or quadriceps tendon with bone pad in
the period from October 2023 to October 2025. When a patient who requires ACL reconstruction
surgery is scheduled in our service, if he meets With the inclusion criteria, you will be
invited to participate in the study and if you accept and give your written informed consent
you will be included in the study. The selection of the graft to be used will be carried out
randomly with a box with a closed envelope, which contains the same number of envelopes with
one or another type of graft, and the resulting option will be the way in which the type of
graft is assigned. graft, which will not be disclosed to the patient during the period of the
study. During the surgical procedure, the repair of concomitant injuries (meniscal or
chondral) will be carried out, and at the end of the surgery, the surgeon will prepare the
surgical report sheet detailing the findings found and the characteristics of the graft used
in terms of thickness, length , and the presence or absence of incidents during surgery.
Subjective clinical scales from IKDC, Kujala, Lysholm, Tegner, and KOOS will be applied.
Measurement of the anterior translation of the tibia will be performed objectively with the
use of the KT-1000 device.
Subjective and objective clinical evaluations with KT-1000 will be carried out preoperatively
and postoperatively at 3, 6, 12 and 24 months by 2 evaluators who will be blinded to the type
of graft used in each patient, for which the anterior part of his knee will be covered with a
20cm long "micropore" band, so that the type of graft cannot be identified by the evaluator
based on the area of the knee and surgical scar. Clinical follow-up of the patient will also
be carried out, in the necessary weeks or months at the discretion of the surgeon or treating
doctor, as is usually carried out in the clinical practice of the institute.
Non-contrast magnetic resonance imaging (MRI) studies will be performed to evaluate the
integrity of the ACL graft, by an orthopedic evaluator with experience in musculoskeletal
imaging, blinded to the type of graft used, to classify it as: intact graft, graft with
partial injury to its fibers or graft with complete injury to its fibers. Knee radiographs
will also be performed (AP projection in standing position, lateral at 30° of flexion and
axial of the patella at 40°), preoperatively and 12 and 24 months after surgery, which will
be evaluated by an orthopedic evaluator with experience in musculoskeletal imaging. , blinded
to the type of graft used, to evaluate the presence or absence of Osteoarthritis according to
the Kellgren & Lawrence classification, in grades 0 to 4.
All patients will be subjected to the same rehabilitation protocol during the first 3-4
months after surgery, as well as follow-up by sports medicine both pre-surgery and from the
3rd to 4th post-surgical month to receive the same muscle strengthening protocol established
in our Institute for patients undergoing ACL reconstruction surgery. Keeping a record of the
evaluation of preoperative and postoperative quadriceps strength in a standardized and
objective manner through isokinetic evaluation with Cybex.
The use of a mechanical knee brace locked to the operated on knee will not be required on a
routine basis, unless there is some indication of its use by the treating surgeon to protect
associated injuries that require it, and in that case the use of It will be for a period of
no more than 6 weeks. Patients must perform assisted ambulation with the use of crutches for
the first 2 weeks with partial support of the operated leg and will subsequently progress to
full support, as long as there is no contraindication on the part of the treating surgeon in
relation to the management of associated injuries.
The presence or absence of adverse events or complications will be documented during 2 years
of minimal monitoring. Parametric and non-parametric statistical tests will be used depending
on whether the case has a normal distribution or not, for dependent and independent groups,
of the related variables that are the result of periodic evaluations (3, 6, 12 and 24 months)
of the same technique. either QT or BPTB, using the SPSS statistical program version 25.