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

Surgery Clinical Trial

Official title:

Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298721
• Other study ID #: 23-885
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Shujaa T Khan, MD
• Phone: 4199658274
• Email: khans34[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).

Description:

The potential candidates for the study are patients scheduled for primary TKA. Scheduled patients will be sent an invitation letter detailing the study's objectives and design. Should they choose to take part, individuals will be requested to utilize MyChart for the completion of PROMs. The information gathered from these PROMs will play a pivotal role in assessing their suitability for inclusion in the study. Subsequently, once deemed eligible, our coordinator will arrange a convenient session to meticulously review and facilitate the signing of the informed consent form (enrollment visit). This enrollment visit will take place approximately 2-3 months prior to the scheduled surgery. Subsequently, enrolled patients will be randomized in a 1:1 ratio to:

i) Standard of Care ii) Standard of Care + TKA Personalized Outcome Prediction Tool (Mental Health Screening/Intervention & Physical Therapy Pre-surgery Assessments/Intervention)

TKA Personalized Outcome Prediction Tool aids in setting expectations for surgery and the results (calculated from patient information and baseline PROMs) will be provided and discussed with the patients by the surgeon.

The primary outcome of the study will be the proportion of patients who fail treatment, defined as patients who answer "no" to the PASS anchor question at 1-year postoperative. The treatment and control groups will be compared using a chi-square test between the randomized groups with p=0.05 as the threshold for statistical significance. We will follow the intent-to-treat principle, and patients assigned to the treatment/intervention arm will be analyzed as such regardless of his/her compliance with the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adult subject (Age >18 and < 80 years of age)

2. The subject is proficient in the English language

3. The patient is voluntarily prepared to sign the 'Informed Consent Form'

4. The patient is scheduled for a unilateral primary TKA

5. TKA PROMs Phenotypes with higher risk of dissatisfaction

6. Patient is willing and able to complete the protocol required follow-up

Exclusion Criteria:

1. Patient requires simultaneous or staged bilateral knee replacements, staged <90 days apart

2. Patients undergoing revision TKA

3. Inflammatory arthritis

4. History of infection in the joint undergoing TKA

5. Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Surgery

Intervention

Behavioral:
• Personalized outcome prediction tool + targeted interventions
TKA Personalized Outcome Prediction Tool to aid in setting expectations Mental Health Screening/Intervention Physical Therapy Pre-surgery Assessments & Rehabilitation
• Standard of Care TKA
- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	American Association of Hip and Knee Surgeons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction at 1 year	Patient Acceptable Symptom State (PASS) anchoring question of: "Taking into account all the activity you have during your daily life, your level of pain and also your activity limitations and participation restrictions, do you consider the current state of your knee satisfactory?" to measure satisfaction	1 year