The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.
Patients will be recruited from the PI's population base at Highlands Sports Medicine Clinic. Patients in need of an ACL reconstruction will be asked if they are interested in participating in a study comparing BTB and QT autografts by the PI (Dr. Amit Momaya). The benefits and risks of each graft choice will be thoroughly explained. Both graft options are considered equally appropriate management. Interested patients will be screened for eligibility criteria by a research assistant; those matching eligibility will be consented and enrolled in person at the time of the visit. Patients will be randomized per trial arm assignment to either (i) assignment "0" or (ii) assignment "1". To ensure randomization, a random number generator is used to assign patient numbers and study groups; these assignments are placed with consent information to remain blinded to research personnel and participants until the consent and enrollment process. We anticipate fifty participants per assignment and oen-hundred participants in total. Assignment 0 represents the BTB group. This procedure harvests the patient's middle third of the patella tendon through a single incision for the new ACL graft. When the graft is in place, the graft is secured using a surgical button at the femoral end and a non-absorbable screw at the tibial end. Assignment 1 represents the QT group. This procedure harvests the patient's quadricep tendon through a single incision then utilizes surgical buttons to fix the graft at the tibial and femoral ends. Following enrollment, patients will immediately be notified of their assignment. Patients will also complete KT-1000 manual maximum side-to-side difference measurements . The patient will then be scheduled for ACL reconstruction surgery according to their assignment. Following reconstruction, standard of care rehabilitation and mobility instructions will be provided. Participants are expected to complete the usual standard of care 2 week, 6 week, 3 month, 6 month, and 9 month postoperative appointments. At the 2 week and 9 month postoperative visits, a routine x-ray will be performed. Aside from a singular KT-1000 measurement and repeated surveys, the patient should not expect any differences in their postoperative visits compared to if they had not participated in the study.
Study Type
INTERVENTIONAL
quadriceps tendon autograft
patellar tendon autograft
UAB Hospital Highlands
Birmingham, Alabama, United States
RECRUITINGKT-1000 Arthrometer
Measures maximum side-to-side difference of laxity (translation of the tibia in comparison to a fix femur)
Time frame: Operative Day, 9 Months Post-Operative Clinic Visit
International Knee Documentation Committee (IKDC) Knee Evaluation Form
The International Knee Documentation Committee Subjective Knee Evaluation Form measures symptoms, function, and sports activity of people with a variety of knee disorders, including ligamentous and meniscal injuries, osteoarthritis, and patellofemoral dysfunction. Normative values have been published for comparison.
Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
This survey evaluates short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis
Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Marx Activity Scale
This survey measures activity-related patient-reported outcome.
Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Single Assessment Numeric Evaluation (SANE)
A rating of the patient's current illness score.
Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Visual analog scale (VAS)
pain rated on a 0-10 scale, 10 being worse
Time frame: Post operative day 1, day 2, day 3, week 1, week 2, week 3, week 4, week 6, 3 months, 6 months, 9 months, 12 months, 24 months
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Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Re-rupture rate
Incidence of rerupture based on clinical and radiographic (MRI) evidence
Time frame: 2 years
Short Term Survey (SF-12)
This survey reports the impact of health on a patient's everyday life.
Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
ACL Return to Sport Index (ACL-RSI)
A survey that evaluates patient's psychological readiness as it relates to return to sport.
Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment