Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461326
• Other study ID #: IRB-300009203
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Amit Momaya, MD
• Phone: 864-436-0621
• Email: amomaya[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Procedure:
• Quad tendon
quadriceps tendon autograft
• BTB
patellar tendon autograft

Locations

Country	Name	City	State
United States	UAB Hospital Highlands	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KT-1000 Arthrometer	Measures maximum side-to-side difference of laxity (translation of the tibia in comparison to a fix femur)	Operative Day, 9 Months Post-Operative Clinic Visit
Secondary	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.	6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Secondary	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	6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Secondary	Marx Activity Scale	This survey measures activity-related patient-reported outcome.	6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Secondary	Single Assessment Numeric Evaluation (SANE)	A rating of the patient's current illness score.	6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Secondary	Visual analog scale (VAS)	pain rated on a 0-10 scale, 10 being worse	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
Secondary	Re-rupture rate	Incidence of rerupture based on clinical and radiographic (MRI) evidence	2 years
Secondary	Short Term Survey (SF-12)	This survey reports the impact of health on a patient's everyday life.	6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Secondary	ACL Return to Sport Index (ACL-RSI)	A survey that evaluates patient's psychological readiness as it relates to return to sport.	6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment