๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-16

Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing (NCT05532189)

ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Columbia University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.

Who can join: Review the eligibility criteria below.

Location: Columbia University Irving Medical Center โ€” New York, New York

Age range: 12 Years

๐Ÿงช Interventions in This Study

  • ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) (PROCEDURE)
  • ACL reconstruction with BTB autograft without internal brace augmentation (suture tape) (PROCEDURE)
  • Standardized Rehabilitation Protocol (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Columbia University Irving Medical Center โ€” New York, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (212) 305-5974

Email: dpt2103@cumc.columbia.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All ACL Tear clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—