๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-05

The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration (NCT03348995)

A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Miach Orthopaedics

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

Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Who can join: Review the eligibility criteria below.

Location: Scripps Health โ€” San Diego, California

Age range: 12 Years to 80 Years

๐Ÿงช Interventions in This Study

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 (11 Sites)

  • Scripps Health โ€” San Diego, California
  • Florida Orthopedic Institute โ€” Tampa, Florida
  • Emory University School Of Medicine โ€” Atlanta, Georgia
  • Ochsner Sports Medicine Institute โ€” New Orleans, Louisiana
  • MedStar Health Surgery Center of Timonium โ€” Lutherville, Maryland
  • Boston Children's Hospital โ€” Boston, Massachusetts
  • Virtua Health โ€” Marlton, New Jersey
  • Cynthia Chrostek โ€” Providence, Rhode Island
  • Orthopedic Institute of Sioux Falls โ€” Sioux Falls, South Dakota
  • UT Southwestern โ€” Dallas, Texas
  • Inova Sports Medicine โ€” Fairfax, Virginia

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.

More studies in Anterior Cruciate Ligament Injury

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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†—