University Orthopedics Part of BEAR-MOON Clinical Trial- A Federally Funded Study Looking At Options For ACL Surgery

Every year, approximately 400,000 anterior cruciate ligament (ACL) injuries occur. ACL reconstruction surgery is one of the most common orthopedic procedures in the United States. Unlike other ligaments, the ends of a torn ACL do not reconnect naturally. During an ACL reconstruction, an orthopedic surgeon removes the ends of the torn ACL and replaces them with a graft, usually taken from either the patellar or the hamstring tendon of the patient. Although most patients can return to sports, the ACL re-tear rate can be as high as 20 percent for teens. Up to 80 percent of patients develop arthritis 15 to 20 years after surgery.

What is the BEAR-MOON Study?

"The BEAR-MOON clinical study will look at whether the BEAR ACL restoration procedure has the same clinical outcomes as a patellar tendon reconstruction.  This randomized clinical trial is being done at 6 sites across the country.  University Orthopedics is the only site in the Northeast region."

What is bridge-enhanced ACL repair?

The bridge-enhanced ACL restoration (BEAR®), uses stitches and a bridging scaffold (a sponge injected with the patient's blood) to stimulate healing of the torn ACL. The procedure has been performed in preclinical models and over 100 patients with excellent results. The goal of the current study is to determine if this new technique, which repairs the torn ACL is comparable to the patellar tendon ACL reconstruction surgery.

What are the differences between ACL reconstruction and the BEAR ACL restoration?

ACL reconstruction:

• standard care for ACL tears, proven to be safe and effective
• requires incision to harvest the graft; other work done arthroscopically
• requires graft harvest of patient's own tendon
• remaining ACL tissue is removed

BEAR Restoration:

• Use of an FDA-approved bridging scaffold to repair the torn ACL
  
• requires incision to insert scaffold; other work done arthroscopically
  
• no graft harvest of patient's tendon
• remaining ACL tissue is preserved

Learn more about the BEAR clinical trial

Currently enrolling into the BEAR-MOON clinical trial. To learn more about the BEARMOON trial or to schedule an appointment with a BEAR-MOON trial physician, please email BEAR.TRIAL@LIFESPAN.ORG or call 1-401-649-1906. You can also learn more about this clinical trial and the BEAR ACL restoration procedure at www.bearmoon.org.

Paul Fadale, MD
Professor: Brown University Medical School
Chief: Division of Sports Medicine
Sports Medicine Fellowship Director
Board Certified: Orthopedic Surgery & Sports Medicine
Head Team Physician: Brown University Athletics, Providence Bruins Professional Hockey (AHL) and Festival Ballet Providence
Phone: 401-457-1538

Michael J. Hulstyn, MD
Adult and Pediatric Sports Medicine Surgery
Shoulder and Knee Surgery
Board Certified and Fellowship-Trained in Orthopedic Sports Medicine
Professor of Orthopaedic Surgery, Brown University, Alpert School of Medicine
Team Physician:  Brown University Athletics, Providence Bruins Professional Hockey (AHL)
Phone: 401-457-1537

Brett Owens, MD
Adult and Pediatric Sports Medicine Surgery
Shoulder and Knee Surgery
Director, The Rhode Island Cartilage Repair Center
Board Certified and Fellowship-Trained in Orthopedic Sports Medicine
Professor of Orthopaedic Surgery, Brown University, Alpert School of Medicine
Team Physician Brown University, Team Physician Providence Bruins (AHL)
Phone: 401-330-1434