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

Total Knee Arthroplasty Clinical Trial

— PAK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266482
• Other study ID #: N21.077
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2022
• Source: Kliniek ViaSana
• Contact: M.C.W.M. Peters, MSc
• Phone: 0031485476330
• Email: onderzoek[@]viasana.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 feedback on their PROs is given.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Kliniek ViaSana	Mill

Sponsors (1)

Lead Sponsor	Collaborator
Kliniek ViaSana

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Pain relief	Measured on a scale from 1 (very much deteriorated) to 7 (very much improved)	3, 6 and 12 months after surgery
Secondary	Functional improvement	Measured on a scale from 1 (very much deteriorated) to 7 (very much improved)	3, 6 and 12 months after surgery
Secondary	Perceived recovery	Measured on a scale from 0 (worse than ever) to 6 (fully recovered)	3, 6 and 12 months after surgery