Personalized Tool + Interventions for Knee Arthritis Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Disqualifiers: Bilateral knee replacements, Inflammatory arthritis, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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).
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.
12345Is 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.
13467How 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.
34589Eligibility 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 between 18 and 80 years old.
+3 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic FoundationCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
American Association of Hip and Knee SurgeonsCollaborator
American Association of Hip and Knee Surgeons (AAHKS)Collaborator
American Association of Hip and Knee SurgeonsCollaborator
References
Developing a personalized outcome prediction tool for knee arthroplasty. [2020]The purpose of this study was to develop a personalized outcome prediction tool, to be used with knee arthroplasty patients, that predicts outcomes (lengths of stay (LOS), 90 day readmission, and one-year patient-reported outcome measures (PROMs) on an individual basis and allows for dynamic modifiable risk factors.
Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA? [2022]Despite the overall effectiveness of total knee arthroplasty (TKA), a subset of patients do not experience expected improvements in pain, physical function, and quality of life as documented by patient-reported outcome measures (PROMs), which assess a patient's physical and emotional health and pain. It is therefore important to develop preoperative tools capable of identifying patients unlikely to improve by a clinically important margin after surgery.
Clinical and Statistical Validation of a Probabilistic Prediction Tool of Total Knee Arthroplasty Outcome. [2020]Predicting patients at risk of a poor outcome would be useful in patient selection for total knee arthroplasty (TKA). Existing models to predict outcome have seen limited functional implementation. This study aims to validate a model and shared decision-making tool for both clinical utility and predictive accuracy.
Patient-reported outcome measures after total knee arthroplasty: a systematic review. [2022]A lack of connection between surgeons and patients in evaluating the outcome of total knee arthroplasty (TKA) has led to the search for the ideal patient-reported outcome measure (PROM) to evaluate these procedures. We hypothesised that the desired psychometric properties of the ideal outcome tool have not been uniformly addressed in studies describing TKA PROMS.
Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative. [2022]Total knee arthroplasty (TKA) is the preferred surgical treatment for end-stage osteoarthritis. However, substantial numbers of patients still experience poor outcomes. Consequently, it is important to identify which patient characteristics are predictive of outcomes in order to guide clinical decisions. Our hypothesis is that preoperative patient-reported outcome measures and radiographic measures may help to predict TKA outcomes.
Utilization of machine learning methods for predicting surgical outcomes after total knee arthroplasty. [2022]Predictive models could help clinicians identify risk factors that cause adverse events after total knee arthroplasty (TKA), allowing for appropriate preoperative preventive interventions and allocation of resources.
Custom total knee arthroplasty combined with personalised alignment grants 94% patient satisfaction at minimum follow-up of 2 years. [2023]The purpose was to report detailed patient-reported outcome measures (PROMs) and satisfaction rates for computed tomography (CT)-based custom TKA at minimum follow-up of 2 years. The hypothesis was that custom TKA combined with 'personalised alignment' would yield equivalent or better PROMs compared to values reported in systematic reviews and meta-analyses on off-the-shelf (OTS) TKA.
Comparison of Responsiveness of Patient-Reported Outcome Measures After Total Knee Arthroplasty. [2023]The aim of this study was to evaluate the responsiveness of different patient-reported outcome measures (PROMs) in patients with primary total knee arthroplasty (TKA).
Comparative responsiveness of outcome measures for total knee arthroplasty. [2022]The aim of this study was to compare the responsiveness of various patient-reported outcome measures (PROMs) and clinician-reported outcomes following total knee arthroplasty (TKA) over a 2-year period.