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Lower Limb Amputation Above Knee (Injury)ASCENT K2NCT04784429

Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

A study testing Kenevo or C-Leg 4 in people with Lower Limb Amputation Above Knee (Injury) and Congenital Amputation of Lower Limb, run by Otto Bock Healthcare Products GmbH at 90 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Kenevo or C-Leg 4
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
90 sitesUnited States
Study dates
11 Jun 2021to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

United States90 sites

  • Hanger Clinic - 607 N. Jefferson Street

    Albany, Georgia, 31707

  • Hanger Clinic - 715 Dr Martin Luther King Jr Ave NE Ste

    Albuquerque, New Mexico, 87102

  • Hanger Clinic - 11346 S Cicero Ave

    Alsip, Illinois, 60803

  • Hanger Clinic - 305 E Greenville St

    Anderson, South Carolina, 29621

  • Hanger Clinic - 4849 Lonetree Way, STE B

    Antioch, California, 94531

  • Hanger Clinic - 1010 Stillwater Ave, Ste 106

    Bangor, Maine, 04401

  • Hanger Clinic - 8522 Summa Ave

    Baton Rouge, Louisiana, 70809

  • Hanger Clinic - 4505 Utica Ridge Rd

    Bettendorf, Iowa, 52722

  • Hanger Clinic - 225 South Michigan Ave Suite B

    Big Rapids, Michigan, 48038

  • Hanger Clinic - 1119 Professional Park Drive

    Brandon, Florida, 33511

  • Hanger Clinic - 3065 William Street, Suite 205

    Cape Girardeau, Missouri, 63703

  • Hanger Clinic - 866 5th Ave SE

    Cedar Rapids, Iowa, 52403

  • Hanger Clinic - 4407 MacCorkle Ave SE

    Charleston, West Virginia, 25304

  • Hanger Clinic - 2219 E. 7th St.

    Charlotte, North Carolina, 28204

  • Hanger Clinic - 2835 N Sheffield Ave, Ste 301

    Chicago, Illinois, 60657

  • Hanger Clinic - 150 St Peters Centre Blvd

    City of Saint Peters, Missouri, 63376

  • Hanger Clinic - 1739 Blanding St.

    Columbia, South Carolina, 29201

  • Hanger Clinic - 8000 State Highway 242, Suite 100

    Conroe, Texas, 77385

  • Hanger Clinic - 1050 Buford Rd, Ste 106

    Cumming, Georgia, 30041

  • Hanger Clinic - 3910 Gaston Ave STE 150

    Dallas, Texas, 75246

  • Hanger Clinic - One Elizabeth Place Suite 300

    Dayton, Ohio, 45417

  • Hanger Clinic - 1400 Mason Ave. Suite 103

    Daytona Beach, Florida, 32117

  • Hanger Clinic - 330 Laurel St. #1300

    Des Moines, Iowa, 50314

  • Hanger Clinic - 321 Westgate Pkwy

    Dothan, Alabama, 36303

  • Hanger Clinic - 423 Normal St.

    East Stroudsburg, Pennsylvania, 18301

  • Hanger Clinic - 660 Wessel Drive

    Fairfield, Ohio, 45014

  • Hanger Clinic - 1743 Creekside, Suite #110

    Folsom, California, 95630

  • Hanger Clinic - 804 Kenyon Road

    Fort Dodge, Iowa, 50521

  • Hanger Clinic - 12591 Creekside Lane

    Fort Myers, Florida, 33919

  • Hanger Clinic - 3501 S Mercy Road

    Gilbert, Arizona, 85297

  • Hanger Clinic - 65 Medical Park Drive, Suite 3

    Helena, Montana, 59601

  • Hanger Clinic - 221 W. Main Street

    Inverness, Florida, 34450

  • Hanger Clinic - 779 W. Forest Ave

    Jackson, Tennessee, 38301

  • Hanger Clinic - 502 Princeton Rd

    Johnson City, Tennessee, 37601

  • Hanger Clinic - 2340 E. Meyer Blvd, Building 2, Suite 394

    Kansas City, Missouri, 64132

  • Hanger Clinic - 5027 Green Bay Rd, Suite 124

    Kenosha, Wisconsin, 53144

  • Hanger Clinic - 320 West Water St, Suite D

    Kerrville, Texas, 78028

  • Hanger Clinic - 308 East Oak Street

    Kissimmee, Florida, 34744

  • Hanger Clinic - 6300 Baum Dr

    Knoxville, Tennessee, 37919

  • Hanger Clinic - 3440 Losey Blvd S

    La Crosse, Wisconsin, 54636

  • Hanger Clinic - 940 Kaliste Saloom

    Lafayette, Louisiana, 70508

  • Hanger Clinic - St. Anthony Hospital - Medical Plaza 1, Suite 230, 11750 West 2nd Place

    Lakewood, Colorado, 80228

  • Hanger Clinic - 7250 Peak Drive, STE 120

    Las Vegas, Nevada, 89128

  • Hanger Clinic - 100 Erdman Way, STE 100

    Leominster, Massachusetts, 01453

  • Hanger Clinic - 1001 S 70th St Ste 110

    Lincoln, Nebraska, 68510

  • Hanger Clinic - 1516 Hudson Street, Suite 105

    Longview, Washington, 98642

  • Hanger Clinic - 778 Riverside Drive

    Macon, Georgia, 31201

  • Hanger Clinic - 266 Cherokee Professional Park

    Maryville, Tennessee, 37804

  • Hanger Clinic - 6001 Landerhaven Dr Ste A

    Mayfield Heights, Ohio, 44124

  • Hanger Clinic - 7 North Bellevue Blvd

    Memphis, Tennessee, 38104

  • Hanger Clinic - 1903 23rd Ave

    Meridian, Mississippi, 39301

  • Hanger Clinic - 100 Milk Street, Suite 120

    Methuen, Massachusetts, 01844

  • Hanger Clinic - 1551 Bond Street, Suite 111

    Naperville, Illinois, 60563

  • Hanger Clinic - 6270 Naples Blvd, Bldg 1

    Naples, Florida, 34109

  • Hanger Clinic - 704 Thimble Shoals Blvd. Suite 400-B

    Newport News, Virginia, 23606

  • Hanger Clinic - 401 Harrison Street

    Oak Park, Illinois, 60304

  • Hanger Clinic - 9109 Blondo Street

    Omaha, Nebraska, 68134

  • Hanger Clinic - 17500 Burke St, Suite 100

    Omaha, Nebraska, 68818

  • Hanger Clinic - 824 Creighton Road

    Pensacola, Florida, 32504

  • Hanger Clinic - 3816 N. 7th St.

    Phoenix, Arizona, 85014

  • Hanger Clinic - 4045 E Bell Rd

    Phoenix, Arizona, 85032

  • Hanger Clinic - 959 Brighton Ave.

    Portland, Maine, 04102

  • Hanger Clinic - 5809 West Norfolk Road

    Portsmouth, Virginia, 23703

  • Hanger Clinic - 961 Matley Ln Ste 100

    Reno, Nevada, 89502

  • Hanger Clinic - 401 SW 41st ST

    Renton, Washington, 98057

  • Hanger Clinic - 4821 Old National Road East, Suite A

    Richmond, Indiana, 47374

  • Hanger Clinic - 1882 Winton Road South, Suite 6

    Rochester, New York, 14618

  • Hanger Clinic - 4001 N Mays St. Ste 1200

    Round Rock, Texas, 78665

  • Hanger Clinic - California - 1248 32nd St

    Sacramento, California, 95816

  • Hanger Clinic - 200 Southpark Blvd, Suite 209

    Saint Augustine, Florida, 32086

  • Hanger Clinic - 645 East Crawford St

    Salina, Kansas, 67401

  • Hanger Clinic - 2785 East 3300 South

    Salt Lake City, Utah, 84109

  • Hanger Clinic - 1139 S.E. Military Dr., Suite 111

    San Antonio, Texas, 78214

  • Hanger Clinic - New Hampshire - 7 Marsh Brook Dr Ste 201

    Somersworth, New Hampshire, 03878

  • Hanger Clinic - 355 W Carpenter St.

    Springfield, Illinois, 62702

  • Hanger Clinic - 1985 Main Street

    Springfield, Massachusetts, 01103

  • Hanger Clinic - 1215A Merchant Way

    Statesboro, Georgia, 30458

  • Hanger Clinic - 1400 College St, Ste 7

    Sulphur Springs, Texas, 75482

  • Hanger Clinic - 13925 Meeker Blvd, Suite 5

    Sun City West, Arizona, 85375

  • Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7

    Torrance, California, 90505

  • Hanger Clinic - 1001 Cromwell Bridge Rd, Suite 108

    Towson, Maryland, 21286

  • Hanger Clinic - 502 Council Circle

    Tupelo, Mississippi, 38801

  • Hanger Clinic - 820 S Akers St, Ste 230

    Visalia, California, 93227

  • Hanger Clinic - 17490 Hwy 3 Unit 100A

    Webster, Texas, 77598

  • Hanger Clinic - 5502 Brush Hollow Rd.

    Westbury, New York, 11590

  • Hanger Clinic - 410 N. Hillside, Suite 100

    Wichita, Kansas, 67214

  • Hanger Clinic - 1399 Westgate Center Dr

    Winston-Salem, North Carolina, 27103

  • Hanger Clinic - 215 First Street North, Suite 300A

    Winter Haven, Florida, 33880

  • Hanger Clinic - 40 Berkshire Ct STE 2

    Wyomissing, Pennsylvania, 19610

  • Hanger Clinic - 1215 Plumas Street, Suite 1000

    Yuba City, California, 95991

Other trials in United States

About this study

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Read the detailed description

Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.

Being tested
Kenevo or C-Leg 4, Non microprocessor controlled knee (NMPK)
Keywords
Prosthetic knee, lower limb amputation, microprocessor controlled knee, K2
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kenevo or C-Leg 4Device

    Kenevo fitted to subjects walking slower than 0.8 m/s as measured by the 2-minute Walk Test. C-Leg 4 fitted to subjects walking faster than 0.8 m/s.

  • Non microprocessor controlled knee (NMPK)Device

    NMPK consistent with current standards of care

Study groups in NCT04784429
Study groupRoleWhat they receive
MPKExperimentalMicroprocessor controlled knee
Receives: Device: Kenevo or C-Leg 4
NMPKActive comparatorNon-microprocessor controlled knee
Receives: Device: Non microprocessor controlled knee (NMPK)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

    Measured: 12 months

  2. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

    Measured: 5 years

Secondary outcomes (13)

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).

    Measured: 12 months

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)

    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

    Measured: 12 months

  3. 12-month fall count from bi-weekly fall journal

    On a bi-weekly cadence, individuals will be asked to complete the Lower Limb Amputation Fall Survey. This survey was developed for the purpose of documenting number of falls and near-falls over a given period, as well as insight into the causality.

    Measured: 12 months

  4. Average daily step counts

    Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 12-month assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.

    Measured: 12 months

  5. Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

    This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

    Measured: 3 years

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    The survey assessment comprises from 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social roles, and pain interference). The combined constructs serve to provide a measure of patient's quality of life. Raw scores are converted to T-scores which standardizes the scores with a mean of 50 and standard deviation of 10. Being above or below the standard deviation could be desirable or undesirable based on the domain being measured. Higher scores means more of the concept being measured (e.g. more fatigue).

    Measured: 5 years

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)

    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

    Measured: 5 years

  8. 10-meter Walk Test (10mWT)

    The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.

    Measured: 5 years

  9. Timed Up and Go (TUG)

    The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.

    Measured: 5 years

  10. Patient-Reported Outcomes Measurement Information System (PROMIS) - 29

    Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 5-year assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.

    Measured: 3 years

  11. Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)

    Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.

    Measured: 3 years

  12. 10-meter Walk Test (10mWT)

    The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.

    Measured: 3 years

  13. Timed Up and Go (TUG)

    The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start11 Jun 2021
  3. Primary completion29 Jun 2023
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04784429
Sponsor's protocol ID
OB113
Acronym
ASCENT K2
Status last verified
Feb 2024
First submitted
2 Mar 2021
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Kenevo or C-Leg 4 in people with Lower Limb Amputation Above Knee (Injury) and Congenital Amputation of Lower Limb, run by Otto Bock Healthcare Products GmbH at 90 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of Falling Avoidance Behavior Questionnaire (FFABQ) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.

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