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

Trial Summary

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 data supports the effectiveness of the treatment Personalized Tool + Interventions for Knee Arthritis Surgery?

Research shows that using personalized prediction tools can help identify which patients are more likely to have successful outcomes after knee replacement surgery. These tools use patient-reported measures and other factors to predict recovery, which can guide doctors in making better treatment decisions. ^{1 2 3 4 5}

Is the personalized tool and interventions for knee arthritis surgery safe for humans?

The research does not provide specific safety data for the personalized tool and interventions for knee arthritis surgery, but it focuses on predicting outcomes and improving patient satisfaction, which suggests a focus on enhancing patient care. ^{1 3 4 6 7}

How is the Personalized Tool + Interventions for Knee Arthritis Surgery treatment different from other treatments?

This treatment is unique because it uses a personalized prediction tool to forecast outcomes for knee surgery, helping doctors and patients make better decisions. It focuses on individual patient data to predict who might have poor results, unlike standard treatments that don't tailor predictions to each person. ^{3 4 5 8 9}

What is the purpose of this trial?

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).

Research Team

Nicolas Piuzzi, MD

Principal Investigator

Cleveland Clinic Ohio

Eligibility Criteria

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 scheduled for a knee replacement surgery on one knee.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Developing a personalized outcome prediction tool for knee arthroplasty. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical and Statistical Validation of a Probabilistic Prediction Tool of Total Knee Arthroplasty Outcome. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures after total knee arthroplasty: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Utilization of machine learning methods for predicting surgical outcomes after total knee arthroplasty. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Custom total knee arthroplasty combined with personalised alignment grants 94% patient satisfaction at minimum follow-up of 2 years. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of Responsiveness of Patient-Reported Outcome Measures After Total Knee Arthroplasty. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Comparative responsiveness of outcome measures for total knee arthroplasty. [2022]