Total Knee ArthroplastyPAKNCT05266482
Personalized Information Before and After Total Knee Arthroplasty: PAK-study
A study testing Personal report in people with Total Knee Arthroplasty, run by Kliniek ViaSana at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Personal report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Mar 2022to 13 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned for primary TKA in Kliniek ViaSana
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personal Feedback on Patient-reported Outcomes to Fulfil or Exceed Preoperative Expectations of Primary Total Knee Arthroplasty Patients: PAK-study.
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Personal report
- Keywords
- Satisfaction, Expectations, Personal feedback
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal reportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Next to the usual care, patients also get the opportunity to download and read a personal report. Receives: Other: Personal report |
| Control group | No intervention | Patients will receive the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (5)
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.
Measured: 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).
Measured: 3, 6 and 12 months after surgery
Pain relief
Measured on a scale from 1 (very much deteriorated) to 7 (very much improved)
Measured: 3, 6 and 12 months after surgery
Functional improvement
Measured on a scale from 1 (very much deteriorated) to 7 (very much improved)
Measured: 3, 6 and 12 months after surgery
Perceived recovery
Measured on a scale from 0 (worse than ever) to 6 (fully recovered)
Measured: 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start9 Mar 2022
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kliniek ViaSana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.M. Brinkman, MD, PhD, Principal investigator, Kliniek ViaSana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266482
- Sponsor's protocol ID
- N21.077
- Acronym
- PAK
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Feedback on Patient-reported Outcomes to Fulfil or Exceed Preoperative Expectations of Primary Total Knee Arthroplasty Patients: PAK-study.
- ClinicalTrials.gov ID
- NCT05266482
- Acronym / sponsor ID
- PAK / N21.077
- Conditions
- Total Knee Arthroplasty
- Keywords
- Satisfaction, Expectations, Personal feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Kliniek ViaSanaUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Personal reportNext to the usual care, patients also get the opportunity to download and read a personal report. |
| Control group | No intervention | –Patients will receive the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned for primary TKA in Kliniek ViaSana
- Signed informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal reportIn 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. | Other | Intervention group |
Primary outcome
Patients' expectations
Time frame: 12 months after surgery
The percentage (0%-100%) of patients who fulfil or exceed their preoperatively set expectations 12 months after TKA surgery. Measured using HSS-KRES.
5 secondary outcomes
Patients' expectations
Time frame: 3 and 6 months after surgery
Patients' satisfaction
Time frame: 3, 6 and 12 months after surgery
Pain relief
Time frame: 3, 6 and 12 months after surgery
Functional improvement
Time frame: 3, 6 and 12 months after surgery
Perceived recovery
Time frame: 3, 6 and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
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VRAS (Velys Robot-Assisted Solution) Operational Excellence Study
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Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
Postoperative Pain After Total Knee Arthroplasty
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Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
Total Knee Arthroplasty
Not yet recruitingPhase 4
Oral Tranexamic Acid After Total Knee Arthroplasty
Total Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.M. Brinkman, MD, PhD principal investigator
Kliniek ViaSana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal report in people with Total Knee Arthroplasty, run by Kliniek ViaSana at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' expectations (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.