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Behavioral Intervention

Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventions for Knee Arthritis

Q: Are potential participants currently able to apply for enrollment in this research study?

Indeed, the details provided on clinicaltrials.gov imply that this study is presently open for patient enrollment. Initially shared on March 12th, 2024 and most recently revised on April 15th, 2024, this trial aims to recruit a total of 300 participants from one designated site.

Q: What is the current number of individuals being enrolled in this research project?

Affirmed. Information available on clinicaltrials.gov reveals that this medical investigation is actively seeking participants. The trial was first publicized on March 12, 2024, and most recently revised on April 15, 2024. A total of 300 patients are sought from a single designated site.

Q: Is the clinical trial open to participants younger than 65 years of age?

Patients between the ages of 18 and 80 are eligible for inclusion in this clinical trial. Notably, there exist 65 studies targeting individuals below 18 years old, while a larger pool of 946 studies focus on patients above the age of 65.

N/A

Recruiting

Led By Nicolas S Piuzzi, MD

Research Sponsored by The Cleveland Clinic

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 1 year

Awards & highlights

Study Summary

This trial will test if using a personalized tool to predict outcomes for knee replacement surgery, along with specific interventions for patients with mental health and physical function issues, can improve patient satisfaction after one year compared to

Who is the study for?

This trial is for adults aged 18-80 who speak English, are scheduled for a unilateral primary total knee arthroplasty (TKA), and are at higher risk of dissatisfaction post-surgery. They must be willing to sign an informed consent form and able to follow the study's protocol.Check my eligibility

What is being tested?

The study tests if using a TKA Personalized Outcome Prediction Tool along with targeted interventions can improve patient satisfaction after one year compared to standard care. It focuses on those with poor mental health or physical function before surgery.See study design

What are the potential side effects?

Since this trial involves personalized tools and standard surgical care rather than drugs, side effects may include typical surgical risks such as infection, pain, bleeding, or complications related to knee replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Satisfaction at 1 year

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventionsExperimental Treatment1 Intervention

Patients who are identified to have a TKA PROMs phenotype which includes lower than median scores for VR-12 MCS will be further screened for: Distress ➔ using the NCCN Distress Thermometer (DT) Depression ➔ using the Patient Health Questionnaire-9 Those patients with a score ≥ 8 on the DT, or a score ≥ 10 on the PHQ-9, or any response other than 0 to question 9 on the PHQ-9 will have a consult with Psychiatry and Behavioral Science to determine a mental health diagnosis. Patients who are identified to have a TKA PROMS phenotype which includes lower than median scores for KOOS-PS (score of =<51.5) will be scheduled for a 4 to 8 week intervention of pre-rehabilitation. All patients who undergo the PT intervention will have a an assessment before and after the rehab TKA.

Group II: Standard of Care TKAActive Control1 Intervention

Patients scheduled to undergo TKA at Cleveland Clinic will follow the standardized TKA Care Pathway as part of Standard of care. Patients enter the TKA care path after consenting to undergo TKA for symptomatic knee pain that has not relieved with nonoperative measures. They stay in the care path until 90-days after the operation is complete. The TKA care path guides the care delivered through the preoperative, intraoperative and postoperative phases.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

American Association of Hip and Knee SurgeonsUNKNOWN

2 Previous Clinical Trials

8,100 Total Patients Enrolled

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,365,258 Total Patients Enrolled

American Association of Hip and Knee Surgeons (AAHKS)UNKNOWN

Frequently Asked Questions

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

Are potential participants currently able to apply for enrollment in this research study?

"Indeed, the details provided on clinicaltrials.gov imply that this study is presently open for patient enrollment. Initially shared on March 12th, 2024 and most recently revised on April 15th, 2024, this trial aims to recruit a total of 300 participants from one designated site."

Answered by AI

What is the current number of individuals being enrolled in this research project?

"Affirmed. Information available on clinicaltrials.gov reveals that this medical investigation is actively seeking participants. The trial was first publicized on March 12, 2024, and most recently revised on April 15, 2024. A total of 300 patients are sought from a single designated site."

Answered by AI

Is the clinical trial open to participants younger than 65 years of age?

"Patients between the ages of 18 and 80 are eligible for inclusion in this clinical trial. Notably, there exist 65 studies targeting individuals below 18 years old, while a larger pool of 946 studies focus on patients above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes

2024. "Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06298721.

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