Personalized Information Before and After Total Knee Arthroplasty: PAK-study
PAK
Personal Feedback on Patient-reported Outcomes to Fulfil or Exceed Preoperative Expectations of Primary Total Knee Arthroplasty Patients: PAK-study.
1 other identifier
interventional
452
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedStudy Start
First participant enrolled
March 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 27, 2022
April 1, 2022
2.7 years
February 23, 2022
April 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Patients' expectations
3 and 6 months after surgery
Patients' satisfaction
3, 6 and 12 months after surgery
Pain relief
3, 6 and 12 months after surgery
Functional improvement
3, 6 and 12 months after surgery
Perceived recovery
3, 6 and 12 months after surgery
Study Arms (2)
Intervention group
EXPERIMENTALNext to the usual care, patients also get the opportunity to download and read a personal report.
Control group
NO INTERVENTIONPatients will receive the usual care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Planned for primary TKA in Kliniek ViaSana
- Signed informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kliniek ViaSanalead
Study Sites (1)
Kliniek ViaSana
Mill, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J.M. Brinkman, MD, PhD
Kliniek ViaSana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2022
First Posted
March 4, 2022
Study Start
March 9, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
April 27, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share