ASCENT K2: Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Sponsor

Otto Bock Healthcare Products GmbH (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04784429

Collaborator

Hanger Clinic: Prosthetics & Orthotics (Other)

100

Enrollment

121

Locations

Arms

66.7

Anticipated Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Limb Amputation Above Knee (Injury) Congenital Amputation of Lower Limb Lower Limb Amputation Knee	Device: Kenevo or C-Leg 4 Device: Non microprocessor controlled knee (NMPK)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Actual Study Start Date :

Jun 11, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MPK Microprocessor controlled knee	Device: Kenevo or C-Leg 4 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.
Active Comparator: NMPK Non-microprocessor controlled knee	Device: Non microprocessor controlled knee (NMPK) NMPK consistent with current standards of care

Arm

Intervention/Treatment

Experimental: MPK

Microprocessor controlled knee

Device: Kenevo or C-Leg 4

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.

Active Comparator: NMPK

Non-microprocessor controlled knee

Device: Non microprocessor controlled knee (NMPK)

NMPK consistent with current standards of care

Outcome Measures

Primary Outcome Measures

Fear of Falling Avoidance Behavior Questionnaire (FFABQ) [12 months]
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.
Fear of Falling Avoidance Behavior Questionnaire (FFABQ) [5 years]
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.

Secondary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 [12 months]
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).
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) [12 months]
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.
12-month fall count from bi-weekly fall journal [12 months]
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.
Average daily step counts [12 months]
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.
Fear of Falling Avoidance Behavior Questionnaire (FFABQ) [3 years]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 [5 years]
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).
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) [5 years]
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.
10-meter Walk Test (10mWT) [5 years]
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.
Timed Up and Go (TUG) [5 years]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29 [3 years]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA) [3 years]
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.
10-meter Walk Test (10mWT) [3 years]
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.
Timed Up and Go (TUG) [3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanger Clinic - Dothan, Alabama - 321 Westgate Parkway, Ste 2	Dothan	Alabama	United States	36303
2	Hanger Clinic - Mobile, Alabama - 2700 Grant Street	Mobile	Alabama	United States	36606
3	Hanger Clinic - Arizona - 1515 East Florence Blvd Units 7,8,9	Casa Grande	Arizona	United States	85122
4	Hanger Clinic - Arizona - 2175 N Alma School Rd., Suite 101	Chandler	Arizona	United States	85224
5	Hanger Clinic - Gilbert, Arizona - 3501 S Mercy road Ste 103	Gilbert	Arizona	United States	85297
6	Hanger Clinic - Arizona - 3816 N. 7th St.,	Phoenix	Arizona	United States	85014
7	Hanger Clinic - Phoenix, Arizona - N 7th St	Phoenix	Arizona	United States	85014
8	Hanger Clinic - Phoenix, Arizona - 4045 E Bell Rd Ste 119	Phoenix	Arizona	United States	85032
9	Hanger Clinic - Arizona - 13925 W Meeker Blvd, Suite 5	Sun City West	Arizona	United States	85375
10	Hanger Clinic - Arizona - East Speedway Blvd	Tucson	Arizona	United States	85712
11	Hanger Clinic - Tucson, Arizona - 395 N Silverbell Rd. STE 301	Tucson	Arizona	United States	85745
12	Hanger Clinic - Arkansas - 1018 Airport Road, Suite 120	Hot Springs	Arkansas	United States	71913
13	Hanger Clinic - Antioch, California - 4849 Lonetree Way STE B	Antioch	California	United States	94531
14	Hanger Clinic - Roseville, California - 1411 Secret Ravine Parkway, Ste 100.	Roseville	California	United States	95661
15	Hanger Clinic - California - 1248 32nd Street	Sacramento	California	United States	95816
16	Hanger Clinic - California - 125 Ciro Ave	San Jose	California	United States	95128
17	hanger Clinic - Torrance, California - 23451 Madison St. Suite 200, Skypark Building 7	Torrance	California	United States	90505
18	Hanger Clinic - California - 1215 Plumas Street, Suite 1000	Yuba City	California	United States	95991
19	Hanger Clinic - Colorado - 175 S Union Blvd	Colorado Springs	Colorado	United States	80910
20	Hanger Clinic - Fort Collins - 3003 E Harmony Rd STE 100	Fort Collins	Colorado	United States	80528
21	Hanger Clinic - Lakewood, Colorado - 11750 West 2nd Place, Plaza 1, Suite 230	Lakewood	Colorado	United States	80228
22	Hanger Clinic - Connecticut - 220 Farmington Avenue Suite 104	Farmington	Connecticut	United States	06032
23	Hanger Clinic - Connecticut - 8260 State Street,	North Haven	Connecticut	United States	06473
24	Hanger Clinic - Connecticut - 1985 Barnum Avenue	Stratford	Connecticut	United States	06615
25	Hanger Clinic - Connecticut - 715 Silas Deane Highway	Wethersfield	Connecticut	United States	01609
26	Hanger Clinic - District of Columbia - 1818 New York Ave, NE	Washington	District of Columbia	United States	20002
27	Hanger Clinic - District of Columbia - 102 Irving Street, NW	Washington	District of Columbia	United States	20010
28	Hanger Clinic - Florida - 1119 Professional Park Drive	Brandon	Florida	United States	33511
29	Hanger Clinic - Inverness, Florida - 221 W. Main Street	Inverness	Florida	United States	34450
30	Hanger Clinic - Kissimmee, Florida - 308 East Oak Street	Kissimmee	Florida	United States	34744
31	Hanger Clinic - Florida - 12301 Lake Underhill Rd., Suite 105	Orlando	Florida	United States	32828
32	Hanger Clinic - Pensacola, Florida - 824 Creighton Road	Pensacola	Florida	United States	32504
33	Hanger Clinic - Florida - 200 Southpark Blvd, Suite 209	Saint Augustine	Florida	United States	32086
34	Hanger Clinic - Florida - 3230 Commerce Place, Suite C	West Palm Beach	Florida	United States	33407
35	Hanger Clinic - Winter Haven - 215 First Street North, Suite 300A	Winter Haven	Florida	United States	33881
36	Hanger Clinic - Albany, Georgia - 607 N. Jefferson Street	Albany	Georgia	United States	31707
37	Hanger Clinic - Georgia - 81 Peachtree Park Drive	Atlanta	Georgia	United States	30309
38	Hanger Clinic - Cumming, Georgia - 1050 Buford Rd, Ste 106	Cumming	Georgia	United States	30041
39	Hanger Clinic - Macon, Georgia - 778 Riverside Drive	Macon	Georgia	United States	31201
40	Hanger Clinic - Georgia - 1838 NW Redmond Circle	Rome	Georgia	United States	30164
41	Hanger Clinic - Alsip, Illinois - 11346 S Cicero Ave	Alsip	Illinois	United States	60803
42	Hanger Clinic - Illinois - 2835 N Sheffield Ave, Ste 301	Chicago	Illinois	United States	60657
43	Hanger Clinic - Naperville Illinois - 1551 Bond Street Suite 111	Naperville	Illinois	United States	60563
44	Hanger Clinic - Indiana - 4821 Old National Road East, Suite A	Richmond	Indiana	United States	47374
45	Hanger Clinic - Bettendorf, Iowa - 4505 Utica Ridge Rd	Bettendorf	Iowa	United States	52722
46	Hanger Clinic - Cedar Rapids, Iowa - 866 5th Ave SE	Cedar Rapids	Iowa	United States	52403
47	Hanger Clinic - Iowa - 330 Laurel St Suite 1300	Des Moines	Iowa	United States	50314
48	Hanger Clinic - Kansas - 3914 Rainbow Blvd	Kansas City	Kansas	United States	66103
49	Hanger Clinic - Kansas - 8919 Parallel Parkway Suite 260	Kansas City	Kansas	United States	66112
50	Hanger Clinic - Salina, Kansas - 645 East Crawford St	Salina	Kansas	United States	67401
51	Hanger Clinic - Wichita, Kansas - 410 N. Hillside, Suite 100	Wichita	Kansas	United States	67214
52	Hanger Clinic - Baton Rouge, Loiusiana - 8522 Summa Ave	Baton Rouge	Louisiana	United States	70809
53	Hanger Clinic - Maine - 1010 Stillwater Ave, SDte 106	Bangor	Maine	United States	04401
54	Hanger Clinic - Portland, Maine - 959 Brighton Ave.	Portland	Maine	United States	04102
55	Hanger Clinic - Maryland - 5051 Greenspring Avenue Suite 103	Baltimore	Maryland	United States	21209
56	Hanger Clinic - Maryland - 5601 Loch Raven Blvd, Suite 107	Baltimore	Maryland	United States	21239
57	Hanger Clinic - Towson, Maryland - 1001 Cromwell Bridge Rd, Suite 108	Towson	Maryland	United States	21286
58	Hanger Clinic - Leominster - Massachusetts - 100 Erdman Way STE 100 , MA	Leominster	Massachusetts	United States	01453
59	Hanger Clinic - Methuen, Massachusetts - 100 Milk Street Suite120	Methuen	Massachusetts	United States	01844
60	Hanger Clinic - Massachusetts - 121 23rd Ave SW Ste 101	Rochester	Massachusetts	United States	55902
61	Hanger Clinic - Springfield, Massachusetts - 1985 Main Street	Springfield	Massachusetts	United States	01103
62	Hanger Clinic - Michigan - 225 South Michigan Ave, Ste B	Big Rapids	Michigan	United States	49307
63	Hanger Clinic - Michigan - 5005 Cascade Rd SE Suite C	Grand Rapids	Michigan	United States	49546
64	Hanger Clinic - Michigan - 2314 Gull Road	Kalamazoo	Michigan	United States	49048
65	Hanger Clinic - Meridian, Mississippi - 1903 23rd Ave	Meridian	Mississippi	United States	39301
66	Hanger Clinic - Cape Girardeau - 3065 William Street, Suite 205	Cape Girardeau	Missouri	United States	63703
67	Hanger Clinic - Saint Peters, Missouri - 150 St Peters Centre Blvd	Saint Peters	Missouri	United States	63376
68	Hanger Clinic - Helena, Montana - 65 Medical Park Drive, Suite 3	Helena	Montana	United States	59601
69	Hanger Clinic - Lincoln, Nebraska - 1001 S 70th St Ste 110	Lincoln	Nebraska	United States	68510
70	Hanger Clinic - Nebraska - 7820 Wakeley Plaza	Omaha	Nebraska	United States	68114
71	Hanger Clinic - Omaha, Nebraska - 9109 Blondo Street	Omaha	Nebraska	United States	68134
72	Hanger Clinic - Las Vegas, Nevada - 7250 Peak Drive STE 120	Las Vegas	Nevada	United States	89128
73	Hanger Clinic - New Hampshire - 7 Marsh Brook Dr Ste 201	Somersworth	New Hampshire	United States	03878
74	Hanger Clinic - New Mexico - 715 Dr Martin Luther King Jr. Ave NE	Albuquerque	New Mexico	United States	87102
75	Hanger Clinic - New Mexico - 313 W. Country Club Rd., Ste 14	Roswell	New Mexico	United States	88201
76	Hanger Clinic - New York - 21 Railroad Ave,	Cooperstown	New York	United States	13326
77	Hanger Clinic - New York - 6620 Fly Rd	East Syracuse	New York	United States	13057
78	Hanger Clinic - New York - 1300 College Ave Ste 1	Elmira	New York	United States	14901
79	Hanger Clinic - New York - 787 State Route 5 And 20	Geneva	New York	United States	14456
80	Hanger Clinic - New York - 635 Main Street	Johnson City	New York	United States	13790
81	Hanger Clinic - New York - 210 East 86th Street	New York	New York	United States	10028
82	Hanger Clinic - New York - 1882 Winton Rd S, Ste 6	Rochester	New York	United States	14618
83	Hanger Clinic - North Carolina - 123 Professional Park Dr Ste 100	Mooresville	North Carolina	United States	28117
84	Hanger Clinic - Winston-Salem, North Carolina - 1399 Westgate Center Dr	Winston-Salem	North Carolina	United States	27103
85	Hanger Clinic - Dayton, Ohio - One Elizabeth Place Suite 300	Dayton	Ohio	United States	45417
86	Hanger Clinic - Fairfield, Ohio - 660 Wessel Drive	Fairfield	Ohio	United States	45014
87	Hanger Clinic - Ohio - 29101 Health Campus Dr Bld 2 St 104	Westlake	Ohio	United States	44145
88	Hanger Clinic - Ohio - 930 Orchard Hill Rd	Zanesville	Ohio	United States	43701
89	Hanger Clinic - Oklahoma - 1904 SE Washington Blvd,	Bartlesville	Oklahoma	United States	74006
90	Hanger Clinic - Oregon - 3220 N Williams Ave	Portland	Oregon	United States	97227
91	Hanger Clinic - East Stroudsburg, Pennsylvania - Normal St	East Stroudsburg	Pennsylvania	United States	18301
92	Hanger Clinic - Pennsylvania - 2108 Harrisburg Pike, Suite 308	Lancaster	Pennsylvania	United States	17604
93	Hanger Clinic - Wyomissing, Pennsylvania - 40 Berkshire Ct STE 2	Wyomissing	Pennsylvania	United States	19610
94	Hanger Clinic - South Dakota - 3930 Cambell St	Rapid City	South Dakota	United States	57701
95	Hanger Clinic - Jackson, Tennessee - 779 W. Forest Ave.	Jackson	Tennessee	United States	38301
96	Hanger Clinic - Johnson City, Tennessee - 502 Princeton Rd.	Johnson City	Tennessee	United States	37601
97	Hanger Clinic - Memphis, Tennesse - 7 North Bellevue Blvd.	Memphis	Tennessee	United States	38104
98	Hanger Clinic - Tennessee - 1814 State Street	Nashville	Tennessee	United States	37203
99	Hanger Clinic - Tennessee - 129 E Division Rd.,	Oak Ridge	Tennessee	United States	37830
100	Hanger Clinic - Texas - 2901 Medical Arts St Suite 500	Austin	Texas	United States	78705
101	Hanger Clinic - Texas - 1301 Barbara Jordan Blvd Suite 306	Austin	Texas	United States	78723
102	Hanger Clinic - Texas - Westgate Blvd, Suite 114,	Austin	Texas	United States	78745
103	Hanger Clinic - Texas - 8000 Anderson Square Suite 301A	Austin	Texas	United States	78757
104	Hanger Clinic - Texas - 1301 Medical Pkwy Suite 120	Cedar Park	Texas	United States	78613
105	Hanger Clinic - Dallas, Texas -3910 Gaston Ave STE 150	Dallas	Texas	United States	75246
106	Hanger Clinic - Texas - 1401 West Magnolia,	Fort Worth	Texas	United States	76104
107	Hanger Clinic - Texas - 11155 South Main St.	Houston	Texas	United States	77025
108	Hanger Clinic - Round Rock, Texas - 4001 N Mays St. Ste 1200	Round Rock	Texas	United States	78665
109	Hanger Clinic - Webster, Texas -17490 Hwy 3 Unit 100A	Webster	Texas	United States	77598
110	Hanger Clinic - Utah - 5316 South Woodrow Street	Murray	Utah	United States	84107
111	Hanger Clinic - Salt Lake City, Utah - 2785 East 3300 South	Salt Lake City	Utah	United States	84109
112	Hanger Clinic - Newport News, VA - Thimble Shoals Blvd	Newport News	Virginia	United States	23606
113	Hanger Clinic - Virginia - 3333 South Crater Rd Suite 3-D	Petersburg	Virginia	United States	23805
114	Hanger Clinic - Virginia - 10710 Midlothian Tpke	Richmond	Virginia	United States	23235
115	Hanger Clinic - Renton, Washington - 401 SW 41st St	Renton	Washington	United States	98057
116	Hanger Clinic - Washington - 1101 Madison St., Ste 550	Seattle	Washington	United States	98104
117	Hanger Clinic - Vancouver, Washington - 505 NE 87th Ave Suite LL10	Vancouver	Washington	United States	98664
118	Hanger Clinic - Charleston, West Virginia - 4407 MacCorkle Ave SE	Charleston	West Virginia	United States	25304
119	Hanger Clinic - Wisconsin - 221 W Madison Street, Ste 7	Eau Claire	Wisconsin	United States	54703
120	Hanger Clinic - Kenosha, Wisconsin - 5027 Green Bay Rd, Suite 124	Kenosha	Wisconsin	United States	53144
121	Hanger Clinic - La Crosse, Wisconsin - 3440 Losey Blvd S	La Crosse	Wisconsin	United States	54636

Sponsors and Collaborators

Otto Bock Healthcare Products GmbH
Hanger Clinic: Prosthetics & Orthotics

Investigators

Principal Investigator: Andreas Kannenberg, MD, PhD, Otto Bock Healthcare Products GmbH
Principal Investigator: Shane Wurdeman, PhD, Hanger Clinic: Prosthetics & Orthotics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Otto Bock Healthcare Products GmbH

ClinicalTrials.gov Identifier:

NCT04784429

Other Study ID Numbers:

OB113

First Posted:

Mar 5, 2021

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Otto Bock Healthcare Products GmbH

Prosthetic knee, lower limb amputation, microprocessor controlled knee, K2

Study Results

No Results Posted as of Jan 24, 2022