ACL Reconstruction with or without Internal Bracing
This study is looking at two ways to repair a torn Anterior Cruciate Ligament (ACL) using your own patella tendon (BTB autograft). One group will have the ACL reconstructed with an internal brace (suture tape) to strengthen it, while the other group will have the reconstruction without the brace. All participants will follow a standard physical therapy plan. Researchers want to see if adding the internal brace helps you return to full activity or sports faster, reduces future knee instability, and improves your physical function. You may be able to join if you are 12 or older, have a first-time ACL injury, and are seen by the Columbia University Sports Medicine Service. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 200 participants. It compares two different surgical approaches for ACL reconstruction.
- What's involved
- Participants will undergo ACL reconstruction surgery and then follow a standardized rehabilitation protocol with physical therapy twice a week.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 10 years to measure time to return to full activity and for recurrent knee instability. Physical function will be measured at baseline and 2 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing
At a glance
Conditions
NCT05532189
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Irving Medical Center
New York, New Yorkstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- David P Trofa, MD · PRINCIPAL_INVESTIGATOR · Associate Professor of Orthopaedic Surgery
Who to contact
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Inclusion
Exclusion
What this trial measures
- Time to Return to Full Activity or SportsMeasured once per participant, depending on the time required to return to full activity (up to 10 years)
Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks
- Percentage of Participants with Recurrent Knee Instability2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Percentage of participants that experience recurrent instability after treatment starts at each time point
- Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeksBaseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PF CAT at 6 weeksBaseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PF CAT at 3 monthsBaseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PF CAT at 6 monthsBaseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PF CAT at 1 yearBaseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PF CAT at 2 yearsBaseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PF CAT at 5 yearsBaseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PF CAT at 10 yearsBaseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Pain Interference (PI) CAT at 2 weeksBaseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PI CAT at 6 weeksBaseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PI CAT at 3 monthsBaseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PI CAT at 6 monthsBaseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PI CAT at 1 yearBaseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PI CAT at 2 yearsBaseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PI CAT at 5 yearsBaseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS PI CAT at 10 yearsBaseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 2 weeksBaseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 6 weeksBaseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 3 monthsBaseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 6 monthsBaseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 1 yearBaseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 2 yearsBaseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 5 yearsBaseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.
- Change in PROMIS Depression CAT at 10 yearsBaseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome.