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NCT04640584Recruiting

C-Brace Prospective Registry

Otto Bock Healthcare Products GmbH

Start Date

4/1/2015

Completion Date

4/1/2026

Summary

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

Detailed Description

The purpose of the C-Brace Prospective Registry is to gather prospective baseline and follow-up data to characterize the safety and effectiveness of the C Brace. Patients casted for C-Brace fitting and willing to provide informed consent at participating clinics will be enrolled in the registry. All patients will be followed in accordance with the standard of care for a C-Brace, which will include, at a minimum, baseline evaluation, fitting, patient training/therapy sessions, follow-up at 6 months, 12 months, 24 months and 36 months after the definitive fitting of the C-Brace.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Patient has been evaluated and successfully tested with the Trial Tool, and has been casted for a C-Brace. * Patient is able to communicate, provide feedback, understand and follow instructions during the course of the registry. * Patient is willing to provide informed consent. Exclusion Criteria: * Patient is geographically inaccessible to comply and participate in the registry. * Patient has not been casted for a C-Brace fitting.

Interventions

DEVICE

C-Brace

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Conditions

ParesesLower Extremity

Locations

Jonesboro P&O x Ottobock.care

Harrison, Arkansas 72601

United States

Jonesboro P&O x Ottobock.care

Rogers, Arkansas 72758

United States

Bionics Orthotics & Prosthetics

San Diego, California 92117

United States

ABI P&O

San Diego, California 92120

United States

West Coast Brace & Limb - Palm Harbor

Palm Harbor, Florida 34684

United States

Hanger - Sarasota

Sarasota, Florida 34233

United States

West Coast Brace & Limb - Tampa

Tampa, Florida 33617

United States

ProCare Prosthetics x Ottobock.care

Buford, Georgia 30518

United States

ProCare x Ottobock.care

Conyers, Georgia 30094

United States

Scheck & Siress: A Hanger Clinic Company

Chicago, Illinois 60657

United States

P&O Care x Ottobock.care

Fairview Heights, Illinois 62208

United States

Kenney Orthopedics - Evansville

Evansville, Indiana 47715

United States

Prevail Prosthetics & Orthotics

Fort Wayne, Indiana 46804

United States

Bionic Prosthetics & Orthotics

Merrillville, Indiana 46410

United States

Kenney Orthopedics - Danville

Danville, Kentucky 40422

United States

Kenney Orthopedics - Lexington

Lexington, Kentucky 40503

United States

Ability x Ottobock.care

Frederick, Maryland 21702

United States

Dankmeyer

Linthicum, Maryland 21090

United States

Medical Center Orthotics & Prosthetics

Silver Spring, Maryland 20910

United States

Cornell Orthotics & Prosthetics

Beverly, Massachusetts 01915

United States

Wright & Filippis x Ottobock.care

Clinton Township, Michigan 48038

United States

Wright & Filippis x Ottobock.care

Farmington Hills, Michigan 48334

United States

Wright & Filippis x Ottobock.care

Flint, Michigan 48504

United States

Wright & Filippis x Ottobock.care

Lansing, Michigan 48912

United States

Wright & Filippis x Ottobock.care

Lapeer, Michigan 48446

United States

Wright & Filippis x Ottobock.care

Livonia, Michigan 48150

United States

Wright & Filippis x Ottobock.care

Madison Heights, Michigan 48071

United States

Limb Lab

Rochester, Minnesota 55904

United States

P&O Care x Ottobock.care

St Louis, Missouri 63131

United States

Limb Lab

Omaha, Nebraska 68106

United States

AlliedOP

Fair Lawn, New Jersey 07410

United States

AlliedOP

Mount Laurel, New Jersey 08054

United States

MedEast Post-op & Surgical

Mount Laurel, New Jersey 08054

United States

Body in Motion

Toms River, New Jersey 08755

United States

Raymond G. Murphy VA

Albuquerque, New Mexico 87108

United States

Orthocraft Inc. - 3856 Flatlands Ave

Brooklyn, New York 11234

United States

VA NY Harbor

Manhattan, New York 10010

United States

Prosthetics in Motion

New York, New York 10001

United States

Reliable P&O

Jacksonville, North Carolina 28546

United States

Bionic Prosthetics & Orthotics

Lenoir, North Carolina 28645

United States

O&P of Pinehurst

Pinehurst, North Carolina 28374

United States

Atlantic Prosthetic Services

Wilmington, North Carolina 28412

United States

Yanke Bionics - W Exchange St

Akron, Ohio 44302

United States

Western Reserve O&P

Austintown, Ohio 44515

United States

Ability P&O x Ottobock.care

Exton, Pennsylvania 19341

United States

Titleman Orthopedic

Philadelphia, Pennsylvania 19083

United States

elizur Corporation

Pittsburgh, Pennsylvania 15237

United States

Ability x Ottobock.care

Wyomissing, Pennsylvania 19610

United States

Ability x Ottobock.care

York, Pennsylvania 17401

United States

South County Artificial Limb and Brace

Wakefield, Rhode Island 02879

United States

Carolina Ottobock.care

Spartanburg, South Carolina 29303

United States

Excel P&O

Kingsport, Tennessee 37660

United States

Restorative Health Services

Murfreesboro, Tennessee 37129

United States

Ottobock.care

Austin, Texas 78758

United States

New Life

Conroe, Texas 77384

United States

Scott Sabolich Prosthetics & Research x Ottobock.care

Dallas, Texas 75148

United States

Baker O&P

Fort Worth, Texas 76104

United States

Hanger Clinic - Houston

Houston, Texas 77025

United States

Michael E. DeBakey VA

Houston, Texas 77030

United States

TIRR Research Center

Houston, Texas 77030

United States

South Texas Veterans Health Care System

San Antonio, Texas 78229

United States

Freedom P & O - 356 E 600 S

St. George, Utah 84770

United States

Hunter Holmes McGuire VA

Richmond, Virginia 23249

United States

VA O&P

Roanoke, Virginia 24012

United States

Cornerstone P&O

Everett, Washington 98203

United States

Cascade Prosthetics & Orthotics

Ferndale, Washington 98248

United States

Hanger Clinic - Renton

Renton, Washington 98057

United States

Pacific Medical

Richland, Washington 99352

United States

Thompson's O&P

Spokane, Washington 99202

United States

Bionic Prosthetics & Orthotics

Green Bay, Wisconsin 54301

United States

Neuromuscular-orthotics.com.au

Clayton, Victoria 3168

Australia

Pohlig BmbH

Traunstein, Bavaria 83278

Germany

Ottobock Göttingen

Göttingen, Deutschland 37075

Germany

John+Bamberg GmbH & Co. KG

Hanover, Lower Saxony 30625

Germany

Katholisches Klinikum Koblenz-Montabaur

Koblenz, Rhineland-Palatinate 56073

Germany

Hyogo Rehabilitation Hospital

Kobe, Hyōgo 651-2181

Japan