Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quad tendon, BTB.
- Who it may be relevant to
- Registry conditions: Orthopedic Disorder, Anterior Cruciate Ligament Injuries. Basic parameters: 14 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Quad tendon
quadriceps tendon autograft - Procedure BTB
patellar tendon autograft
Primary outcome measures
- KT-1000 Arthrometer [Time frame: Operative Day, 9 Months Post-Operative Clinic Visit]
Secondary outcome measures (8)
- International Knee Documentation Committee (IKDC) Knee Evaluation Form [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) [Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment]
- Marx Activity Scale [Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment]
- Single Assessment Numeric Evaluation (SANE) [Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment]
- Visual analog scale (VAS) [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]
- Re-rupture rate [Time frame: 2 years]
- Short Term Survey (SF-12) [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) [Time frame: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UAB Hospital Highlands — Birmingham
Identifiers
NCT: NCT05461326 · IRB-300009203 · UAB