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Technology Interventions for Knee Replacement Surgery

N/A
Recruiting
Led By Christine Pellegrini, PhD
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Had unilateral knee replacement within last 12 months
Be 40-79 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights

Study Summary

This trial will study the effects of two different technology interventions on health outcomes after knee replacement surgery, at 2 and 5 months post-op.

Who is the study for?
This trial is for English-speaking adults aged 40-79 who've had a knee replacement in the last year, spend much of their day sitting, and are comfortable using smartphone apps. It's not for those with mobility issues unrelated to their knee or upcoming surgeries.Check my eligibility
What is being tested?
The study is testing two tech tools, MyKneeGuide and NEAT!2, designed to help patients recover after knee surgery by tracking physical activity and providing guidance. The effects will be measured at 2 months and again at 5 months post-surgery.See study design
What are the potential side effects?
Since this trial involves technology-based interventions rather than medications, traditional side effects are not expected. However, participants may experience frustration or difficulty if they're not tech-savvy or have trouble interacting with the apps.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a knee replacement surgery on one knee in the last year.
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I am between 40 and 79 years old.
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I spend 7 or more hours a day sitting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months
Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months
Secondary outcome measures
Adherence to NEAT!2 app
Adherence to NEAT!2 calls
Change in Physical Function
+4 more
Other outcome measures
Change in Knee Symptoms - KOOS ADL
Change in Knee Symptoms - KOOS QoL
Change in Knee Symptoms - KOOS pain
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NEAT!2Experimental Treatment1 Intervention
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
Group II: MyKneeGuideActive Control1 Intervention
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor
211 Previous Clinical Trials
120,367 Total Patients Enrolled
Northwestern UniversityOTHER
1,587 Previous Clinical Trials
916,969 Total Patients Enrolled
Prisma Health-MidlandsOTHER
23 Previous Clinical Trials
2,734 Total Patients Enrolled

Media Library

NEAT!2 Clinical Trial Eligibility Overview. Trial Name: NCT04482400 — N/A
Total Knee Arthroplasty Research Study Groups: NEAT!2, MyKneeGuide
Total Knee Arthroplasty Clinical Trial 2023: NEAT!2 Highlights & Side Effects. Trial Name: NCT04482400 — N/A
NEAT!2 2023 Treatment Timeline for Medical Study. Trial Name: NCT04482400 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the maximum age limit of this trial set at thirty?

"This research initiative is open to individuals aged 40 and above, up until 79 years of age."

Answered by AI

What is the primary aim of this experiment?

"This experiment's primary endpoint is the alteration in objectively gauged (Actigraph) sedentary behaviour following a 3 month baseline. Secondary objectives encompass compliance with NEAT!2, response to NEAT!2 alerts, and modulation of WOMAC Pain Subscale which ranges from 0 (no pain) to 20 (highest level of distress)."

Answered by AI

Is the recruitment phase of this clinical trial still underway?

"Clinicaltrials.gov confirms that this medical investigation is actively seeking patients; the trial was inaugurated on August 1st 2020, with its most recent update posted in February 2022."

Answered by AI

Is enrollment for this clinical investigation still open?

"This experiment requires 92 participants aged 40 to 79, who have recently had a unilateral knee replacement and own an Android or iOS device that is kept close by. Furthermore, they must be English-speaking, spend at least 7 hours per day sitting down, and be willing to install the study applications on their smartphone."

Answered by AI

How many participants are taking part in this clinical research?

"Affirmative. The clinical trial's information hosted on clinicaltrials.gov shows that this study is presently recruiting participants who were first posted to the site on August 1st 2020, and was last updated in February 2022. 92 patients will be recruited at a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Technology Interventions to Improve Outcomes After Knee Replacement
Christine A Pellegrini, PhD 2020. "Technology Interventions to Improve Outcomes After Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04482400.
~11 spots leftby Oct 2024
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