Subchondroplasty® Knee RCT

NACompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

March 29, 2017

Primary Completion Date

August 23, 2023

Study Completion Date

August 23, 2023

Conditions
Bone Marrow EdemaKnee Pain ChronicKnee OsteoarthritisOsteoarthritis, KneeOsteoarthritis
Interventions
PROCEDURE

Subchondroplasty with Arthroscopy

The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.

PROCEDURE

Arthroscopy Alone

An endoscopic examination, therapy and surgery of the knee joint.

Trial Locations (13)

21093

MedStar Health Research Institute, Timonium

22903

University of Virginia, Charlottesville

29615

Hawkins Foundation, Greenville

30329

Emory University, Atlanta

33637

Foundation for Orthopaedic Research and Education, Tampa

43202

The Ohio State University, Columbus

78745

Orthopedic Associates of Central Texas, Austin

87106

New Mexico Orthopaedic Fellowship Foundation, Albuquerque

92024

CORE Orthopaedic Medical Center, Encinitas

92354

Loma Linda University Health System, Loma Linda

94305

Stanford University, Stanford

60612-3833

Rush University Medical Center, Chicago

L8N4A6

Research St. Joseph's - Hamilton, Hamilton

All Listed Sponsors
collaborator

MedNet Solutions

UNKNOWN

collaborator

Medical Metrics Diagnostics, Inc

INDUSTRY

lead

Zimmer Biomet

INDUSTRY