Clinical trial NCT03762603: Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)
Official title: Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Primary Knee Replacement Surgery
Keywords: Pneumatic
exoskeleton
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study involves an exoskeleton which is believed to increase quadriceps muscle strength in the rehabilitation phase after TKA and reduce the discharge the such patients in Extended care facility (ECF) . The purpose of this study is to access efficacy of the robotic exoskeleton device wrapped around the operated knee on patients


Eligibility criteria: Inclusion criteria

1. Patients undergoing unilateral primary knee replacement surgery
2. Patients who pre-operatively desire discharged to ECF
3. Patients willing and capable to sign the written informed consent

Exclusion criteria

1. Patients undergoing bilateral primary knee replacement surgery
2. Patients undergoing revision knee replacement surgery
3. Patients who pre-operatively desire discharged to Home
4. Patients not willing and capable to sign the written informed consent

Primary outcomes:
measure: Predicting discharge location after TKA
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
timeFrame: upto 2 weeks
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
timeFrame: upto 2 weeks
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
timeFrame: upto 2 weeks
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
timeFrame: up to 2 years
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
timeFrame: up to 2 years
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
timeFrame: up to 2 years
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
timeFrame: up to 2 years
measure: Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
timeFrame: 2 weeks and 3 months
measure: Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
timeFrame: 2 weeks and 3 months
measure: Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
timeFrame: 2 weeks and 3 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Derek Amanatullah, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005 Jul;87(7):1487-97. doi: 10.2106/JBJS.D.02441.
citation: Losina E, Walensky RP, Kessler CL, Emrani PS, Reichmann WM, Wright EA, Holt HL, Solomon DH, Yelin E, Paltiel AD, Katz JN. Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume. Arch Intern Med. 2009 Jun 22;169(12):1113-21; discussion 1121-2. doi: 10.1001/archinternmed.2009.136.
citation: Healy WL, Rana AJ, Iorio R. Hospital economics of primary total knee arthroplasty at a teaching hospital. Clin Orthop Relat Res. 2011 Jan;469(1):87-94. doi: 10.1007/s11999-010-1486-2.
citation: Schwarzkopf R, Ho J, Quinn JR, Snir N, Mukamel D. Factors Influencing Discharge Destination After Total Knee Arthroplasty: A Database Analysis. Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):95-9. doi: 10.1177/2151458516645635. Epub 2016 Apr 26.
citation: Goto K, Morishita T, Kamada S, Saita K, Fukuda H, Shiota E, Sankai Y, Inoue T. Feasibility of rehabilitation using the single-joint hybrid assistive limb to facilitate early recovery following total knee arthroplasty: A pilot study. Assist Technol. 2017 Winter;29(4):197-201. doi: 10.1080/10400435.2016.1219883. Epub 2016 Aug 10.