Orthopedic innovative care studies
Title: BEAR – MOON Trial – A Two Arm Non-Inferiority Randomized Clinical Trial Comparing Anterior Cruciate Ligament (ACL) Repair with BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction
PI: Bradley Nelson, MD
Sponsor: NIH
Location: TRIA Bloomington
Purpose: The purpose of this study is to evaluate bridge-enhanced ACL repair (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction.
Title: PTOA – Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament (ACL) Injured Patients
PI: Bradley Nelson, MD
Sponsor: Department of Defense
Location: TRIA Bloomington & TRIA Woodbury
Purpose: The purpose of this study is to determine whether treatment with Tranexamic Acid, an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of Post-Traumatic Osteoarthritis.
Title: STaR – Surgical Timing and Rehabilitation for Multiple Ligament Knee Injuries
PI: Bradley Nelson, MD
Sponsor: Department of Defense
Location: TRIA Bloomington & TRIA Woodbury
Purpose: The purpose of this study is to investigate the effects of timing of surgery (early vs. delayed) and timing of post-operative rehabilitation (early vs. delayed) for the treatment of military personnel and civilians that sustain a multiple ligament knee injury.
Title: RTSA – Immediate Accelerated Shoulder Rehabilitation vs. a Standard Physical Therapy Protocol following Reverse Total Shoulder Arthroplasty
PI: Michael Walsh, MD
Sponsor: HealthPartners Institute
Location: TRIA Bloomington
Purpose: The purpose of this study is to compare clinical measures, patient-reported outcomes, and cost effectiveness of an immediate accelerated rehabilitation protocol vs. a standard physical therapy protocol following Reverse Total Shoulder Arthroplasty.
Title: Novocart – NOVOCART® 3D for Treatment of Articular Cartilage of the Knee
PI: Marc Tompkins, MD
Sponsor: Aesculap Biologics, LLC
Location: TRIA Bloomington & TRIA Woodbury
Purpose: The purpose of this study is to measure the safety and efficacy of NOVOCART® 3D, compared to Microfracture in the treatment of articular cartilage defects.
