Personalized Information Before and After Total Knee Arthroplasty: PAK-study

Study Overview
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Brief Summary
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Despite positive results following total knee arthroplasty (TKA), some patients are dissatisfied after recovery. Unfulfilled expectations is a key predictor of dissatisfaction. The aim of this study is to investigate if more patients fulfil or exceed their preoperative expectations one year after TKA when personal feedback on their PROs is given.

Official Title
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Personal Feedback on Patient-reported Outcomes to Fulfil or Exceed Preoperative Expectations of Primary Total Knee Arthroplasty Patients: PAK-study.

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Other: Personal report


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned for primary TKA in Kliniek ViaSana Signed informed consent Exclusion Criteria: Aged under 18 years Do not possess an own email adress, Do not have a thorough command of the Dutch language, Previously received contra-lateral primary TKA and/or unicompartmental KA.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Next to the usual care, patients also get the opportunity to download and read a personal report. | Other: Personal report<br>* In the intervention group, in addition to receiving the usual care, patients will receive personal reports on multiple time points. These reports include feedback on their PROs including reference scores of patients who previously underwent total knee replacement surgery.<br>|
| No Intervention: Control group<br>Patients will receive the usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' expectations | The percentage (0%-100%) of patients who fulfil or exceed their preoperatively set expectations 12 months after TKA surgery. Measured using HSS-KRES. | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' expectations | The percentage (0%-100%) of patients who fulfil or exceed their preoperatively set expectations 3 and 6 months after TKA surgery. Measured using HSS-KRES. | 3 and 6 months after surgery | 
| Patients' satisfaction | Satisfaction score with the outcome of TKA surgery. Measured using NRS satisfaction from 0 (dissatisfied) to 10 (satisfied). | 3, 6 and 12 months after surgery | 
| Pain relief | Measured on a scale from 1 (very much deteriorated) to 7 (very much improved) | 3, 6 and 12 months after surgery | 
| Functional improvement | Measured on a scale from 1 (very much deteriorated) to 7 (very much improved) | 3, 6 and 12 months after surgery | 
| Perceived recovery | Measured on a scale from 0 (worse than ever) to 6 (fully recovered) | 3, 6 and 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Satisfaction, Expectations, Personal feedback