Orthopedic DisorderNCT05461326
Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT
A study testing Quad tendon and BTB in people with Orthopedic Disorder and Anterior Cruciate Ligament Injuries, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Orthopedic Disorder, Anterior Cruciate Ligament Injuries
- What is being tested?
- Quad tendon and BTB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Skeletally mature patients younger 65
- ACL insufficiency
- Scheduled to undergo autograft ACL reconstruction
- Appropriate candidate for autograft harvest
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB Hospital Highlands
Birmingham, Alabama, 35205
Amit Momaya, MD, (205)-930-8339, amomaya@uabmc.edu
Elizabeth M Benson, MS
About this study
Official title: All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Quad tendon, BTB
- Keywords
- quadriceps tendon, bone tendon bone, autograft
- Medical subject headings
- Musculoskeletal Diseases, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quad tendonProcedure or surgery
quadriceps tendon autograft
BTBProcedure or surgery
patellar tendon autograft
| Study group | Role | What they receive |
|---|---|---|
| Quad tendon | Active comparator | ACL graft harvested from the quadriceps tendon Receives: Procedure: Quad tendon |
| BTB tendon | Active comparator | ACL graft harvested from the patellar tendon Receives: Procedure: BTB |
What is being measured
The primary outcome is the main question the study is designed to answer.
KT-1000 Arthrometer
Measures maximum side-to-side difference of laxity (translation of the tibia in comparison to a fix femur)
Measured: Operative Day, 9 Months Post-Operative Clinic Visit
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Incidence of rerupture based on clinical and radiographic (MRI) evidence
Measured: 2 years
Short Term Survey (SF-12)
This survey reports the impact of health on a patient's everyday life.
Measured: 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.
Measured: 6 weeks, 3 months, 6 months, 9 months, 12 months, and 24 months post-operative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start26 Sep 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
- Investigators
- Amit Momaya, MD, Principal investigator, Department of Orthopaedic Surgery, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461326
- Sponsor's protocol ID
- IRB-300009203
- Other IDs
- UAB
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05461326
- Acronym / sponsor ID
- IRB-300009203
- Keywords
- quadriceps tendon, bone tendon bone, autograft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quad tendon | Active comparator | Procedure: Quad tendonACL graft harvested from the quadriceps tendon |
| BTB tendon | Active comparator | Procedure: BTBACL graft harvested from the patellar tendon |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Skeletally mature patients younger 65
- ACL insufficiency
- Scheduled to undergo autograft ACL reconstruction
- Appropriate candidate for autograft harvest
Key exclusion criteria (7 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quad tendonquadriceps tendon autograft | Procedure or surgery | Quad tendon |
| BTBpatellar tendon autograft | Procedure or surgery | BTB tendon |
Primary outcome
KT-1000 Arthrometer
Time frame: Operative Day, 9 Months Post-Operative Clinic Visit
Measures maximum side-to-side difference of laxity (translation of the tibia in comparison to a fix femur)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Momaya, MD principal investigator
Department of Orthopaedic Surgery, University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quad tendon and BTB in people with Orthopedic Disorder and Anterior Cruciate Ligament Injuries, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Momaya, MD (864-436-0621, amomaya@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KT-1000 Arthrometer (time frame: Operative Day, 9 Months Post-Operative Clinic Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.