Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837872
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2021-04-06
Brief Title:
Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2021-04
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 the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following total knee arthroplasty TKA Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to manipulation under anesthesia MUA which is the current standard of care for knee stiffness after TKA
Detailed Description:
Total knee arthroplasty TKA is the standard of care to manage the pain and disability associated with end-stage knee osteoarthritis with more than 700000 TKA surgeries performed annually in the United States Knee stiffness commonly caused by arthrofibrosis is an infrequent but debilitating complication of TKA with an incidence upwards of 5 postoperatively As a predominant failure mechanism knee stiffness accounts for 28 of hospital readmissions due to surgical complications within 90 days of discharge and 10 of all revisions within 5 years of initial surgery within the United States With the incidence of TKA projected to reach 35 million by 2030 the growing cohort of TKA patients with postoperative knee stiffness provides an important target for research
Several treatments for knee stiffness have been described including static progressive splinting and manipulation under anesthesia MUA To date no studies have compared the use of static progressive splinting in the early management of individuals presenting with knee stiffness after TKA to more commonly utilized surgical procedures such as MUA Witvrouw and colleagues compared a computer-controlled passive motion device to MUA for individuals with knee stiffness after TKA and found that stretching device had similar outcomes to MUA in terms of range of motion ROM and self-reported pain stiffness and function A key limitation of this study is that the computer-controlled motion device is not commercially available and therefore translation of this technology into practice is unlikely However this study does demonstrate that conservative stretching techniques may be as efficacious as costlier surgical techniques as well as may cause fewer adverse events such as quadriceps tendon rupture and fractures Only one study to date has examined the utilization of static progressive splinting after TKA In this study they enrolled patients who had already failed MUA and conservative physical therapy management strategies They found that the average ROM increase for patients was 25 as well as 92 of patients were satisfied with the results and no complications occurred with use of the device Key limitations to this study are the lack of a comparison group as well as static progressive splinting was utilized after MUA had already failed It is unknown how individuals would respond to this treatment compared to MUA
Therefore the purpose of our study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following TKA within the current surgical practice of Dr Jared Foran at Panorama Orthopedics Spine Center Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to MUA which is the current standard of care for knee stiffness after TKA
Several treatments for knee stiffness have been described including static progressive splinting and manipulation under anesthesia MUA To date no studies have compared the use of static progressive splinting in the early management of individuals presenting with knee stiffness after TKA to more commonly utilized surgical procedures such as MUA Witvrouw and colleagues compared a computer-controlled passive motion device to MUA for individuals with knee stiffness after TKA and found that stretching device had similar outcomes to MUA in terms of range of motion ROM and self-reported pain stiffness and function A key limitation of this study is that the computer-controlled motion device is not commercially available and therefore translation of this technology into practice is unlikely However this study does demonstrate that conservative stretching techniques may be as efficacious as costlier surgical techniques as well as may cause fewer adverse events such as quadriceps tendon rupture and fractures Only one study to date has examined the utilization of static progressive splinting after TKA In this study they enrolled patients who had already failed MUA and conservative physical therapy management strategies They found that the average ROM increase for patients was 25 as well as 92 of patients were satisfied with the results and no complications occurred with use of the device Key limitations to this study are the lack of a comparison group as well as static progressive splinting was utilized after MUA had already failed It is unknown how individuals would respond to this treatment compared to MUA
Therefore the purpose of our study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following TKA within the current surgical practice of Dr Jared Foran at Panorama Orthopedics Spine Center Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to MUA which is the current standard of care for knee stiffness after TKA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None