Personalized Tool + Interventions for Knee Arthritis Surgery

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Satisfaction at 1 year

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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