Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05266482
Acronym
PAK
Enrollment
452
Registered
2022-03-04
Start date
2022-03-09
Completion date
2024-12-31
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Keywords

Satisfaction, Expectations, Personal feedback

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.

Interventions

OTHERPersonal 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.

Sponsors

Kliniek ViaSana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patients' expectations12 months after surgeryThe percentage (0%-100%) of patients who fulfil or exceed their preoperatively set expectations 12 months after TKA surgery. Measured using HSS-KRES.

Secondary

MeasureTime frameDescription
Patients' expectations3 and 6 months after surgeryThe percentage (0%-100%) of patients who fulfil or exceed their preoperatively set expectations 3 and 6 months after TKA surgery. Measured using HSS-KRES.
Patients' satisfaction3, 6 and 12 months after surgerySatisfaction score with the outcome of TKA surgery. Measured using NRS satisfaction from 0 (dissatisfied) to 10 (satisfied).
Pain relief3, 6 and 12 months after surgeryMeasured on a scale from 1 (very much deteriorated) to 7 (very much improved)
Functional improvement3, 6 and 12 months after surgeryMeasured on a scale from 1 (very much deteriorated) to 7 (very much improved)
Perceived recovery3, 6 and 12 months after surgeryMeasured on a scale from 0 (worse than ever) to 6 (fully recovered)

Countries

Netherlands

Contacts

Primary ContactM.C.W.M. Peters, MSc
onderzoek@viasana.nl0031485476330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026