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Zero Degree Knee Positioner for Post-Knee Replacement Recovery
N/A
Waitlist Available
Research Sponsored by Prisma Health-Midlands
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial looks at how early rehab after knee surgery (TKA) and a device (Zero Degree Knee positioner) can help people regain knee extension and gait faster.
Who is the study for?
This trial is for men and women aged 40-80 who are about to have knee replacement surgery due to mild to advanced osteoarthritis. They must be able to walk on their own before the surgery. People who don't speak English, are pregnant, have had a previous knee replacement in the same leg, or have other conditions affecting their joints or gait can't join.Check my eligibility
What is being tested?
The study tests if using the Zero Degree Knee positioner after knee replacement surgery helps patients straighten their leg and improve walking sooner than usual care. Participants will either use this device at home following surgery or receive standard rehab instructions.See study design
What are the potential side effects?
Since this trial involves a non-invasive device used for rehabilitation rather than medication, side effects may include discomfort from using the positioner as directed during recovery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of the Zero Degree Knee device on post-operative knee extension in patients at 2 weeks post-op following total knee replacement as measured by lateral radiograph and physician interpretation.
Secondary outcome measures
Effect of the Zero Degree Knee device on KOOS scores in patients undergoing total knee replacement surgery.
Effect of the Zero Degree Knee device on PROMIS Mobility scores in patients undergoing total knee replacement surgery.
Effect of the Zero Degree Knee device on PROMIS Pain Interference scores in patients undergoing total knee replacement surgery.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Zero Degree KneeExperimental Treatment1 Intervention
Patients will receive the Zero Degree Knee device and instructions for use following total knee replacement.
Group II: Standard of CareActive Control1 Intervention
Patients will receive standard of care instructions rehabilitation instructions following total knee replacement.
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Who is running the clinical trial?
Prisma Health-MidlandsLead Sponsor
23 Previous Clinical Trials
2,672 Total Patients Enrolled
1 Trials studying Osteoarthritis
16 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a knee replacement in the same leg that needs surgery now.I have a condition like arthritis affecting my walking or joint movement.I do not speak English.I am between 40 and 80 years old.I am a candidate for a total knee replacement surgery.I have been diagnosed with osteoarthritis, from mild to advanced.I can walk on my own without help.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Zero Degree Knee
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor open to adults over the age of twenty?
"This research study accepts patients aged 40-80 years old."
Answered by AI
Are individuals presently being sought for participation in this medical research?
"Unfortunately, the information on clinicaltrials.gov declares that this research is not currently in a recruitment phase. It was initially published on January 15th 2023 and last updated nine days later. Despite this, there are 667 other active trials searching for participants at present."
Answered by AI
Which demographics are being recruited for participation in this clinical trial?
"This medical study is looking to include 154 patients aged 40-80 with osteoarthritis of the knee that meet the following prerequisites: walking without assistance, both genders within specified age range, requiring a total arthroplasty and exhibiting mild to severe symptoms."
Answered by AI
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