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

Not Applicable

Recruiting

• Conditions: Total Knee Arthroplasty
• Interventions: Other: Personal report

• Registration Number: NCT05266482
• Lead Sponsor: Kliniek ViaSana

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Study Start: 2022-03-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 452

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Personal report	Next to the usual care, patients also get the opportunity to download and read a personal report.

Primary Outcome Measures

Name	Time	Method
Patients' expectations	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.

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction	3, 6 and 12 months after surgery	Satisfaction score with the outcome of TKA surgery. Measured using NRS satisfaction from 0 (dissatisfied) to 10 (satisfied).
Pain relief	3, 6 and 12 months after surgery	Measured on a scale from 1 (very much deteriorated) to 7 (very much improved)
Functional improvement	3, 6 and 12 months after surgery	Measured on a scale from 1 (very much deteriorated) to 7 (very much improved)
Patients' expectations	3 and 6 months after surgery	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.
Perceived recovery	3, 6 and 12 months after surgery	Measured on a scale from 0 (worse than ever) to 6 (fully recovered)

Trial Locations

Locations (1)

Kliniek ViaSana; 🇳🇱 Mill, Netherlands