Clinical trial NCT05461326: Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT
Official title: All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Anterior Cruciate Ligament Injuries
Keywords: quadriceps tendon
bone tendon bone
autograft
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature patients younger 65
* ACL insufficiency
* Scheduled to undergo autograft ACL reconstruction
* Appropriate candidate for autograft harvest

Exclusion Criteria:

* \<14 or 65\>
* Poor autograft candidate (poor tissue quality)
* Multi ligamentous reconstruction (PCL, MCL, or PLC)
* Pregnant or nursing
* High likelihood of remaining non-compliant with physical therapy regimen
* Desire to return to sport prior to 6 months
* Inability to read and write English

Primary outcomes:
measure: KT-1000 Arthrometer
timeFrame: Operative Day, 9 Months Post-Operative Clinic Visit
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) Knee Evaluation Form
timeFrame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
measure: Marx Activity Scale
timeFrame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
measure: Visual analog scale (VAS)
timeFrame: 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
measure: Re-rupture rate
timeFrame: 2 years
measure: Short Term Survey (SF-12)
timeFrame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
measure: ACL Return to Sport Index (ACL-RSI)
timeFrame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital Highlands
state: Alabama
Study officials:
affiliation: Department of Orthopaedic Surgery, University of Alabama at Birmingham
name: Amit Momaya, MD
role: PRINCIPAL_INVESTIGATOR
References: