Personalized Tool + Interventions for Knee Arthritis Surgery

Overseen By Alison Klika

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Bilateral knee replacements, Inflammatory arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized tool, combined with specific interventions, can improve satisfaction after knee replacement surgery compared to standard care. It focuses on individuals who might be less satisfied with their surgery results due to poor mental or physical health before the operation. Participants will either follow the usual care path or receive additional support based on personal health predictors using the personalized outcome prediction tool. This trial suits those scheduled for knee replacement who experience ongoing knee pain not relieved by other treatments and may face mental health or physical challenges. As an unphased trial, this study offers a unique opportunity to explore personalized care options that could enhance the recovery experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this personalized outcome prediction tool and targeted interventions are safe for knee arthritis surgery?

Research has shown that personalized tools predicting recovery after knee surgery are safe. These tools help patients understand what to expect during recovery. While studies primarily focus on the accuracy of these predictions, no safety issues have emerged in the research.

Additional support, such as mental health care and physical therapy, is common in healthcare. Receiving mental health support and physical therapy before knee surgery helps patients manage both mentally and physically. These practices are generally well-received and have been used safely in various settings.

Overall, using the prediction tool alongside these supports is expected to be safe based on current evidence. No specific safety problems have been reported with these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines a personalized outcome prediction tool with targeted interventions to enhance care for knee arthritis surgery, specifically total knee arthroplasty (TKA). Unlike standard TKA procedures, which follow a one-size-fits-all approach, this method customizes patient care based on individual risk factors and needs. The unique aspect of this method is that it screens patients for mental health issues and physical function levels, ensuring those with higher distress or lower physical scores receive additional support, like psychiatric consultations or pre-rehabilitation. This personalized approach aims to improve recovery outcomes and overall patient satisfaction by addressing specific challenges before and after surgery.

What evidence suggests that the Personalized Outcome Prediction Tool with targeted interventions is effective for knee arthritis surgery?

This trial will compare a personalized outcome prediction tool with targeted interventions against standard care for knee surgery patients. Research has shown that a personalized tool can aid knee surgery patients by predicting their recovery outcomes. This tool uses patient information and pre-surgery tests to set clear recovery expectations. Studies indicate that understanding these predictions increases patient satisfaction with surgery results. In this trial, some participants will receive specific support for mental health or physical challenges identified by the tool, potentially improving recovery. Addressing these needs before surgery may lead to better outcomes and overall satisfaction. ^{1 2 3 4 6}

Who Is on the Research Team?

Nicolas Piuzzi, MD

Principal Investigator

Cleveland Clinic Ohio

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My knee replacement might lead to dissatisfaction due to certain risk factors.

I am willing and able to follow the study's required check-ups and procedures.

I am proficient in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 months

Enrollment visit

Pre-surgery Intervention

Patients undergo mental health screening and physical therapy pre-surgery assessments/interventions

4-8 weeks

Surgery and Immediate Postoperative Care

Patients undergo TKA surgery and follow the standardized TKA Care Pathway

90 days

Follow-up

Participants are monitored for satisfaction and outcomes at 1 year post-surgery

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Personalized outcome prediction tool + targeted interventions
• Standard of Care TKA

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventions Experimental Treatment 1 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 TKA Active Control 1 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.

Personalized outcome prediction tool + targeted interventions is already approved in United States, European Union for the following indications:

Approved in United States as TKA Personalized Outcome Prediction Tool for:

• Improving satisfaction in total knee arthroplasty patients
• Predicting outcomes in TKA patients

Approved in European Union as Personalized Outcome Prediction Tool for TKA for:

• Improving satisfaction in total knee arthroplasty patients
• Predicting outcomes in TKA patients

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

American Association of Hip and Knee Surgeons

Collaborator

Trials

4

Recruited

2,300+

American Association of Hip and Knee Surgeons (AAHKS)

Collaborator

Trials

1

Recruited

300+

American Association of Hip and Knee Surgeons

Collaborator

Trials

4

Recruited

2,300+

Published Research Related to This Trial

A personalized outcome prediction tool for knee arthroplasty patients was developed, demonstrating good accuracy in predicting length of stay (LOS) and 90-day readmission rates, with accuracies of 71.5% and 65.0% respectively.

The tool also effectively predicted one-year improvements in patient-reported outcomes, achieving high accuracy rates of around 72% for pain, function, and quality of life scores, based on data from over 8,000 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a personalized outcome prediction tool for knee arthroplasty. Anis, HK., Strnad, GJ., Klika, AK., et al.[2020]

A systematic review of 38 studies involving 85,541 subjects found that no single patient-reported outcome measure (PROM) for total knee arthroplasty (TKA) has been universally validated to meet all desired psychometric properties, such as validity, reliability, and responsiveness.

Despite the evaluation of 47 different PROMs, only six studies acknowledged all 'gold standard' psychometric properties, indicating a significant gap in the development of effective tools to measure TKA outcomes from the patient's perspective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures after total knee arthroplasty: a systematic review. Ramkumar, PN., Harris, JD., Noble, PC.[2022]

Gradient Boosting Method (GBM) predictive models outperformed other machine learning models in predicting outcomes after total knee arthroplasty (TKA), with Brier scores indicating good calibration and area under the ROC curve (AUC) scores ranging from 79-87%.

Key predictors for post-surgical complications included patient demographics such as admission month, location, income level, and specific health conditions like deficiency anemias, highlighting the importance of these factors in preoperative assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of machine learning methods for predicting surgical outcomes after total knee arthroplasty. Mohammed, H., Huang, Y., Memtsoudis, S., et al.[2022]

In a study of 140 patients who underwent custom total knee arthroplasty (TKA) with personalized alignment, 94% reported being satisfied or very satisfied at an average follow-up of 33.5 months, indicating high patient satisfaction with this approach.

The study found that 89% of patients achieved a patient acceptable symptom state (PASS) for the Oxford Knee Score (OKS) and 85% for the Forgotten Joint Score (FJS), with these outcomes comparing favorably to those reported for off-the-shelf (OTS) TKAs in systematic reviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom total knee arthroplasty combined with personalised alignment grants 94% patient satisfaction at minimum follow-up of 2 years. Gousopoulos, L., Dobbelaere, A., Ratano, S., et al.[2023]

In a study of 98 patients undergoing total knee arthroplasty (TKA), the Knee Society Score (KSS) and WOMAC index showed the largest improvements in patient-reported outcomes at 2 months post-surgery, indicating they are effective measures for early recovery assessment.

The Forgotten Joint Score-12 (FJS-12) was found to be the most responsive measure overall, particularly beyond one year post-surgery, suggesting that it may better reflect patient outcomes related to joint awareness compared to traditional clinician-reported or generic health measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative responsiveness of outcome measures for total knee arthroplasty. Giesinger, K., Hamilton, DF., Jost, B., et al.[2022]

A Bayesian belief network model was developed to predict outcomes for patients considering total knee arthroplasty (TKA), showing that it can effectively identify patients at risk of limited improvement after surgery.

The tool demonstrated significant predictive accuracy, revealing a 27% chance of not improving for patients predicted at risk, compared to only a 1.4% chance for those predicted to improve, thus aiding in better patient selection for TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Statistical Validation of a Probabilistic Prediction Tool of Total Knee Arthroplasty Outcome. Twiggs, JG., Wakelin, EA., Fritsch, BA., et al.[2020]

In a study of 562 patients undergoing total knee arthroplasty (TKA), preoperative scores on the Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-12 version 2 (SF12v2) were found to predict the likelihood of clinically meaningful improvement in function one year post-surgery, with specific threshold values identified (KOOS: 58, SF12v2 PCS: 34).

Patients with higher preoperative scores were less likely to experience significant improvements after TKA, and those with poorer mental and emotional health had a lower probability of achieving meaningful functional gains, highlighting the importance of considering both physical and mental health in preoperative assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA? Berliner, JL., Brodke, DJ., Chan, V., et al.[2022]

In a study of 309 total knee arthroplasty patients, the Knee Society Score (KSS) and the Knee injury and Osteoarthritis Outcome Score (KOOS) showed the largest responsiveness to changes in patient condition, indicating they are effective measures for assessing outcomes after surgery.

The KOOS-12 and Forgotten Joint Score (FJS-12) demonstrated the highest responsiveness overall, although the KOOS-12 experienced ceiling effects, suggesting that while these measures are sensitive to change, they may not capture the full range of patient improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Responsiveness of Patient-Reported Outcome Measures After Total Knee Arthroplasty. Vogel, N., Kaelin, R., Rychen, T., et al.[2023]

In a study of 172 patients undergoing total knee arthroplasty (TKA), higher preoperative WOMAC scores for disability and pain were strongly associated with better postoperative outcomes, indicating that these patient-reported measures can help predict recovery.

Radiographic measures, specifically combined Kellgren and Lawrence (KL) grades and preoperative joint angles, also correlated with postoperative improvements, suggesting that patients with better joint alignment and lower KL grades may experience more favorable outcomes after TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative. Kahn, TL., Soheili, A., Schwarzkopf, R.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32862678/

Developing a personalized outcome prediction tool for ... The purpose of this study was to develop a personalized outcome prediction tool, to be used with knee arthroplasty patients, that predicts outcomes.

2. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/0301-620X.102B9.BJJ-2019-1642.R1

Developing a personalized outcome prediction tool for knee ... The purpose of this study was to develop a personalized outcome prediction tool, to be used with knee arthroplasty patients, that predicts ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06298721

Study Details | NCT06298721 | Improving Total Knee ... TKA Personalized Outcome Prediction Tool aids in setting expectations for surgery and the results (calculated from patient information and baseline PROMs) will ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/personalized-outcome-prediction-of-pain-and-functional-changes-following-total-knee-arthroplasty

Personalized Outcome Prediction of Pain and Functional ... This tool provides a visual display of the patient's predicted outcomes of their surgery, which is easily interpreted.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540325011465

Can Preoperative Patient-Reported Outcome Measures ... This study compared the power of preoperative PROMs to predict clinical outcomes after TKA to established indices, including the Charlson ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12344954/

Predicting Outcome One Year After Knee Arthroplasty - PMC Data were collected from patients undergoing primary knee arthroplasty for primary osteoarthritis recruited to the Evaluation of perioperative ...