Ignite Creation Date:
2024-05-06 @ 3:36 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02339831
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2015-01-09
Brief Title:
Active Versus Passive Motion Device Following Knee Replacement Surgery
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Prospective Randomized Controlled Single Center Study Evaluating the Clinical Performance of CAMOPED Following Knee Replacement
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how well an active motion device Camoped works compared to a continuous passive motion device CPM for rehabilitation after partial or total knee replacement It is hypothesized that the Camoped active motion device will provide outcomes equal to or superior than the CPM Patients undergoing either partial or total knee replacement will be given the opportunity to participate If they elect to participate preoperative data will be collected including demographics measures of strength balance and knee bending as well as surveys regarding current physical and mental health as well as knee function After surgery patients will be randomly selected to receive either the Camoped or the CPM for use during their rehabilitation After discharge participants will be asked to maintain a daily diary tracking their use of the assigned device as well as their daily pain levels At a visit 4 weeks after surgery participants will be asked to complete a series of surveys pertaining to their health and knee function as well as to perform tests of strength balance and knee bending These results will be used to determine if one device produces superior rehabilitation results following total or partial knee replacement surgery
Detailed Description:
The purpose of this study is to determine how well an active motion device Camoped works compared to a continuous passive motion device CPM for rehabilitation after partial or total knee replacement It is hypothesized that the Camoped active motion device will provide outcomes equal to or superior than the CPM 110 patients will be randomized during the course of the study Participation lasts approximately 4 weeks Data for patients who begin the trial but choose to drop out or are lost to follow up will not be included in analysis
Patients who have elected to undergo surgery with one of the PIs either a total knee replacement with Dr Richard Scott or a partial knee replacement with Dr Wolfgang Fitz will be informed about the study and offered participation if they meet eligibility criteria The PI will obtain written consent in the office for those who choose to participate For participants demographic data including height weight BMI age and sex will be collected Additionally sit-to-stand knee flexion proprioception strength and balance testing will be performed in the office by a physical therapist Participant responses to the SF-36 physical and mental health surveys knee function score KSS and WOMAC questionnaires will also be collected
Patients will be randomized to receive either the Camoped or CPM device after surgery Patients will receive the device and its protocol for usage in the hospital following surgery They will use the device for the duration of their hospital stay and then take the device home At home patients will be asked to keep a daily diary tracking device usage as well as daily pain and medication intake These results will be compared as part of the study analysis
When patients return for their follow-up appointment four weeks after surgery demographic data including height weight BMI age and sex will be collected Additionally sit-to-stand knee flexion proprioception strength and balance testing will be performed in the office Participant responses to the SF-36 physical and mental health surveys knee function score KSS and WOMAC questionnaires will also be collected These measures will be compared to the preoperative results
Two-sample t-tests will be used to analyze the similarity between the two treatment groups before the intervention and to assess any differences afterwards The Wilcoxon-Mann Whitney test will be performed as a non-parametric alternative to t-testing for any data sets found to be non-normal
Data collection and management will be the responsibility of the PIs All adverse events will be reported as necessary
Patients who have elected to undergo surgery with one of the PIs either a total knee replacement with Dr Richard Scott or a partial knee replacement with Dr Wolfgang Fitz will be informed about the study and offered participation if they meet eligibility criteria The PI will obtain written consent in the office for those who choose to participate For participants demographic data including height weight BMI age and sex will be collected Additionally sit-to-stand knee flexion proprioception strength and balance testing will be performed in the office by a physical therapist Participant responses to the SF-36 physical and mental health surveys knee function score KSS and WOMAC questionnaires will also be collected
Patients will be randomized to receive either the Camoped or CPM device after surgery Patients will receive the device and its protocol for usage in the hospital following surgery They will use the device for the duration of their hospital stay and then take the device home At home patients will be asked to keep a daily diary tracking device usage as well as daily pain and medication intake These results will be compared as part of the study analysis
When patients return for their follow-up appointment four weeks after surgery demographic data including height weight BMI age and sex will be collected Additionally sit-to-stand knee flexion proprioception strength and balance testing will be performed in the office Participant responses to the SF-36 physical and mental health surveys knee function score KSS and WOMAC questionnaires will also be collected These measures will be compared to the preoperative results
Two-sample t-tests will be used to analyze the similarity between the two treatment groups before the intervention and to assess any differences afterwards The Wilcoxon-Mann Whitney test will be performed as a non-parametric alternative to t-testing for any data sets found to be non-normal
Data collection and management will be the responsibility of the PIs All adverse events will be reported as necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None