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

NCT ID: NCT05266482

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

Next to the usual care, patients also get the opportunity to download and read a personal report.

Group Type EXPERIMENTAL

Personal report

Intervention Type OTHER

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.

Control group

Patients will receive the usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Personal report

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kliniek ViaSana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J.M. Brinkman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kliniek ViaSana

Locations

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Kliniek ViaSana

Mill, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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M.C.W.M. Peters, MSc

Role: CONTACT

0031485476330

Facility Contacts

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M. Peters

Role: primary

Other Identifiers

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N21.077

Identifier Type: -

Identifier Source: org_study_id

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