Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Launched by OTTO BOCK HEALTHCARE PRODUCTS GMBH · Mar 2, 2021
Trial Information
Current as of May 27, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how different types of knee prostheses, or artificial knees, affect people who have lost a leg above the knee. Specifically, it compares microprocessor-controlled knee prostheses (which use smart technology to help with movement) to non-microprocessor-controlled knees. The trial includes individuals who have had a leg amputated above the knee due to injury or congenital conditions and who are classified as K2 ambulators, meaning they can walk with some assistance.
To participate, individuals should be at least 65 years old, have received their prosthesis within the last 4 to 24 months, and be able to speak either English or Spanish. They should also feel comfortable with their prosthesis, rated at least a 6 out of 10 in comfort. Participants can expect to be part of a study that aims to improve outcomes for people with similar amputations, but they should also know that there are specific criteria that may exclude them from joining, such as certain health conditions or weight limits. This trial is currently active but not recruiting new participants.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Unilateral transfemoral or knee disarticulation amputation
- • Received prosthesis between 4 - 24 months prior
- • Currently uses prosthesis
- • K2 ambulator status
- • Able to speak English or Spanish language
- • Age ≥ 65 years at Baseline Assessment (one month after enrollment)
- • Minimum Socket Comfort Score (SCS) of 6/10
- Exclusion Criteria:
- • Upper limb involvement
- • Individuals ≥ 275 lbs
- • Unable to provide informed consent
- • History of acute or chronic residual limb breakdown
- • History of 2 or more socket adjustments or replacements in the past 6 months
- • Amputation of the contralateral limb
- • Active malignancy
- • Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical \& Scientific Affairs personnel
- • Patient unable or unwilling to follow study procedures
- • Pregnant women, institutionalized persons, and children
About Otto Bock Healthcare Products Gmbh
Otto Bock Healthcare Products GmbH is a leading global provider of innovative medical solutions, specializing in the development and manufacturing of advanced prosthetics, orthotics, and rehabilitation products. With a commitment to enhancing the quality of life for individuals with mobility challenges, the company leverages cutting-edge technology and extensive clinical research to deliver high-performance healthcare products. Otto Bock is dedicated to advancing patient care through rigorous clinical trials and collaborations with healthcare professionals, ensuring that their offerings meet the highest standards of safety, efficacy, and user satisfaction.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dothan, Alabama, United States
Mobile, Alabama, United States
Casa Grande, Arizona, United States
Chandler, Arizona, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Sun City West, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Antioch, California, United States
Roseville, California, United States
Sacramento, California, United States
San Jose, California, United States
Torrance, California, United States
Yuba City, California, United States
Colorado Springs, Colorado, United States
Fort Collins, Colorado, United States
Lakewood, Colorado, United States
Farmington, Connecticut, United States
North Haven, Connecticut, United States
Stratford, Connecticut, United States
Wethersfield, Connecticut, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Brandon, Florida, United States
Inverness, Florida, United States
Kissimmee, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Saint Augustine, Florida, United States
West Palm Beach, Florida, United States
Winter Haven, Florida, United States
Albany, Georgia, United States
Atlanta, Georgia, United States
Cumming, Georgia, United States
Macon, Georgia, United States
Rome, Georgia, United States
Alsip, Illinois, United States
Chicago, Illinois, United States
Naperville, Illinois, United States
Richmond, Indiana, United States
Bettendorf, Iowa, United States
Cedar Rapids, Iowa, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Kansas City, Kansas, United States
Salina, Kansas, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Bangor, Maine, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Leominster, Massachusetts, United States
Methuen, Massachusetts, United States
Rochester, Massachusetts, United States
Springfield, Massachusetts, United States
Big Rapids, Michigan, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Meridian, Mississippi, United States
Cape Girardeau, Missouri, United States
Saint Peters, Missouri, United States
Helena, Montana, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Somersworth, New Hampshire, United States
Albuquerque, New Mexico, United States
Roswell, New Mexico, United States
Cooperstown, New York, United States
East Syracuse, New York, United States
Elmira, New York, United States
Geneva, New York, United States
Johnson City, New York, United States
New York, New York, United States
Rochester, New York, United States
Mooresville, North Carolina, United States
Winston Salem, North Carolina, United States
Dayton, Ohio, United States
Fairfield, Ohio, United States
Westlake, Ohio, United States
Zanesville, Ohio, United States
Bartlesville, Oklahoma, United States
Portland, Oregon, United States
East Stroudsburg, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Rapid City, South Dakota, United States
Jackson, Tennessee, United States
Johnson City, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Oak Ridge, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Cedar Park, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Round Rock, Texas, United States
Webster, Texas, United States
Murray, Utah, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
Petersburg, Virginia, United States
Richmond, Virginia, United States
Renton, Washington, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Charleston, West Virginia, United States
Eau Claire, Wisconsin, United States
Kenosha, Wisconsin, United States
La Crosse, Wisconsin, United States
Folsom, California, United States
Visalia, California, United States
Daytona Beach, Florida, United States
Fort Myers, Florida, United States
Naples, Florida, United States
Statesboro, Georgia, United States
Oak Park, Illinois, United States
Springfield, Illinois, United States
Fort Dodge, Iowa, United States
Lafayette, Louisiana, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Westbury, New York, United States
Charlotte, North Carolina, United States
Mayfield Heights, Ohio, United States
Anderson, South Carolina, United States
Knoxville, Tennessee, United States
Maryville, Tennessee, United States
Conroe, Texas, United States
Kerrville, Texas, United States
San Antonio, Texas, United States
Sulphur Springs, Texas, United States
Portsmouth, Virginia, United States
Longview, Washington, United States
Dothan, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Sun City West, Arizona, United States
Antioch, California, United States
Folsom, California, United States
Sacramento, California, United States
Torrance, California, United States
Visalia, California, United States
Yuba City, California, United States
Lakewood, Colorado, United States
Brandon, Florida, United States
Daytona Beach, Florida, United States
Fort Myers, Florida, United States
Inverness, Florida, United States
Kissimmee, Florida, United States
Naples, Florida, United States
Pensacola, Florida, United States
Saint Augustine, Florida, United States
Winter Haven, Florida, United States
Albany, Georgia, United States
Cumming, Georgia, United States
Macon, Georgia, United States
Statesboro, Georgia, United States
Alsip, Illinois, United States
Chicago, Illinois, United States
Naperville, Illinois, United States
Oak Park, Illinois, United States
Springfield, Illinois, United States
Richmond, Indiana, United States
Bettendorf, Iowa, United States
Cedar Rapids, Iowa, United States
Des Moines, Iowa, United States
Fort Dodge, Iowa, United States
Salina, Kansas, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Lafayette, Louisiana, United States
Bangor, Maine, United States
Portland, Maine, United States
Towson, Maryland, United States
Leominster, Massachusetts, United States
Methuen, Massachusetts, United States
Springfield, Massachusetts, United States
Big Rapids, Michigan, United States
Meridian, Mississippi, United States
Tupelo, Mississippi, United States
Cape Girardeau, Missouri, United States
Kansas City, Missouri, United States
Saint Peters, Missouri, United States
Helena, Montana, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Westbury, New York, United States
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Dayton, Ohio, United States
Fairfield, Ohio, United States
Mayfield Heights, Ohio, United States
East Stroudsburg, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Jackson, Tennessee, United States
Johnson City, Tennessee, United States
Knoxville, Tennessee, United States
Maryville, Tennessee, United States
Memphis, Tennessee, United States
Conroe, Texas, United States
Dallas, Texas, United States
Kerrville, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
Sulphur Springs, Texas, United States
Webster, Texas, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
Portsmouth, Virginia, United States
Longview, Washington, United States
Renton, Washington, United States
Charleston, West Virginia, United States
Kenosha, Wisconsin, United States
La Crosse, Wisconsin, United States
Patients applied
Trial Officials
Andreas Kannenberg, MD, PhD
Principal Investigator
Otto Bock Healthcare Products GmbH
Shane Wurdeman, PhD
Principal Investigator
Hanger Clinic: Prosthetics & Orthotics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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