An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)

NCT04023578 | Completed Results FDA Device

• 1 other identifier: CIP-P197
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study was to evaluate the mobility, perceived safety and functioning of unilateral transfemoral (TF) amputees using the Rheo Knee XC compared to their existing prosthetic knee (RHEO KNEE II, III or Genium, X2 or X3) after 3 weeks of use. The primary objective of the study was to determine/investigate whether unilateral (TF) amputees can apply and benefit from the stair ascent function of the Rheo Knee XC and compare the stair ascent function and automatic cycling detection of the Rheo Knee XC to hydraulic microprocessor controlled knees (MPK-HY). The testing was conducted in a non-blinded, multicenter, prospective within subject comparison, with a subgroup analysis with Magneto-rheologic microprocessor controlled knees (MPK-MR) subgroup and MPK-HY subgroup comparing to the Rheo knee XC. A convenience sample of 15 transfemoral amputee users was recruited at 4 study sites. Inclusion criteria:

• Cognitive ability to understand all instructions and questionnaires in the study;
• Unilateral knee-disarticulated or transfemoral users fitted to Rheo Knee II,III or Genium
• Willing and able to participate in the study and follow the protocol
• Confident prosthetic users for more than 3 months
• Older than 18 years Exclusion Criteria
• Patients with the following characteristics are not eligible for study entry:
• 50Kg\> body weight \> 136Kg
• Users with cognitive impairment
• Users not understanding the function of the knee
• Users not able to charge the battery Testing was conducted between June and August 2015 in four US locations. Participants visited the study location twice, for approximately 3 hours per visit. First time for the baseline measure and initial fitting and secondly after 3 weeks of accommodation on the Rheo knee XC, performing the same measures as for the baseline. Measures included 6 minute walk test with Borg scale CR pre and post, L-test, stair assessment index, stair and bicycle evaluation and Prosthesis evaluation questionnaire mobility section (PEQ MS12/5) For statistics repeated measures analysis of variance (ANOVA) comparing baseline to 3 week follow up were performed.

Conditions

Prosthesis User; Amputation

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test (6MWT)

  The 6MWT is simply a record of the distance traveled by a given patient at his or her self-selected walking speed over a period of six minutes. All that is required is a stopwatch and a walking corridor or track of known distance. Those administering the test should avoid walking with or in front of test subjects to avoid pacing individuals outside of their self-selected walking speed. The outcome of the test is the distance walked in 6 minutes, in meters.

  Measured at baseline and after 3 weeks follow up.

Study Arms (1)

Rheo Knee XC

EXPERIMENTAL

Amputee subjects currently using either magneto-rehologic or hydraulic MPKs are fitted with the Rheo Knee XC, a magneto-rheologic MPK.

Device: RHEO KNEE XC

Interventions

RHEO KNEE XC DEVICE

Microprocessor controlled knee using Magneto-Rheologic techonology.

Rheo Knee XC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitive ability to understand all instructions and questionnaires in the study;
• Unilateral kneedisartic or transfemoral users fitted to Rheo Knee II,III Genium or X2 or X3
• Willing and able to participate in the study and follow the protocol
• Confident prosthetic users for more than 3 months
• Older than 18 years

You may not qualify if:

• Kg\> body weight \> 136Kg
• Users with cognitive impairment
• Users not understanding the function of the knee
• Users not able to charge the battery

Sponsors & Collaborators

• Össur Iceland ehf: lead
• Baker Orthotics & Prosthetics: collaborator
• Virginia Prosthetics & Orthotics: collaborator
• Methodist Rehabilitation Center: collaborator

Study Sites (4)

Ossur Americas, Florida Gait lab

Orlando, Florida, 32812, United States

Location

Methodist Rehabilitation Center

Flowood, Mississippi, 39232, United States

Location

Baker Orthotics & Prosthetics

Fort Worth, Texas, 76104, United States

Location

Virginia Prosthetics & Orthotics

Roanoke, Virginia, 24012, United States

Location

Related Publications (8)

• Hafner BJ, Willingham LL, Buell NC, Allyn KJ, Smith DG. Evaluation of function, performance, and preference as transfemoral amputees transition from mechanical to microprocessor control of the prosthetic knee. Arch Phys Med Rehabil. 2007 Feb;88(2):207-17. doi: 10.1016/j.apmr.2006.10.030.

  PMID: 17270519 BACKGROUND

• Starholm IM, Gjovaag T, Mengshoel AM. Energy expenditure of transfemoral amputees walking on a horizontal and tilted treadmill simulating different outdoor walking conditions. Prosthet Orthot Int. 2010 Jun;34(2):184-94. doi: 10.3109/03093640903585016.

  PMID: 20141493 BACKGROUND

• Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-8. doi: 10.5271/sjweh.1815.

  PMID: 2345867 BACKGROUND

• Gailey RS, Roach KE, Applegate EB, Cho B, Cunniffe B, Licht S, Maguire M, Nash MS. The amputee mobility predictor: an instrument to assess determinants of the lower-limb amputee's ability to ambulate. Arch Phys Med Rehabil. 2002 May;83(5):613-27. doi: 10.1053/apmr.2002.32309.

  PMID: 11994800 BACKGROUND

• Deathe AB, Miller WC. The L test of functional mobility: measurement properties of a modified version of the timed "up & go" test designed for people with lower-limb amputations. Phys Ther. 2005 Jul;85(7):626-35.

  PMID: 15982169 BACKGROUND

• Franchignoni F, Monticone M, Giordano A, Rocca B. Rasch validation of the Prosthetic Mobility Questionnaire: A new outcome measure for assessing mobility in people with lower limb amputation. J Rehabil Med. 2015 May;47(5):460-5. doi: 10.2340/16501977-1954.

  PMID: 25783231 BACKGROUND

• Resnik L, Borgia M. Reliability of outcome measures for people with lower-limb amputations: distinguishing true change from statistical error. Phys Ther. 2011 Apr;91(4):555-65. doi: 10.2522/ptj.20100287. Epub 2011 Feb 10.

  PMID: 21310896 BACKGROUND

• Franchignoni F, Giordano A, Ferriero G, Orlandini D, Amoresano A, Perucca L. Measuring mobility in people with lower limb amputation: Rasch analysis of the mobility section of the prosthesis evaluation questionnaire. J Rehabil Med. 2007 Mar;39(2):138-44. doi: 10.2340/16501977-0033.

  PMID: 17351696 BACKGROUND

Results Point of Contact

• Title: Kristleifur Kristleifsson
• Organization: Ossur Iceland ehf

kkristjansson@ossur.com

6641112

Study Officials

• Justin Pratt, M.Sc.

  Ossur Iceland ehf

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 17, 2019
• Study Start: June 30, 2015
• Primary Completion: August 4, 2015
• Study Completion: August 4, 2015
• Last Updated: April 6, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)