Tergooi MC
Hilversum, Netherlands
NCT Number: NCT07041528
After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guidelines. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up.
The HAKA trial consists of three different work packages (WPs).The quantitative work packages 1 (WP1) and 2 (WP2) will investigate the 1-year and 10-year follow-up. The qualitative third work package (WP3) will explore and compare the patients' and health care professionals' (HCPs) experiences with, and perceptions about, RFU and COD after total hip and knee arthroplasty. The aim of the overarching HAKA-trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.
Trial opening soon.
Get Notified50 year and older
All sexes
Observational
Hilversum, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Experiences gained between the baseline clinical visit and a clinical visit one year later.
The participants' experiences will be explored using a mix of semi-structured open-ended focus group questions.
Time frame: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.
The participants' satisfaction will be explored using a mix of semi-structured open-ended focus group questions.
Time frame: Experiences gained between the baseline clinical visit and a clinical visit one year later.
The health care professionals' experiences will be explored using a mix of semi-structured open-ended interview questions.
Time frame: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.
The health care professionals' satisfaction will be explored using a mix of semi-structured open-ended interview questions.
Time frame: Acceptability of follow-up regimens from the baseline clinical visit to a clinical visit one year later.
The participants' and health care professionals' acceptability of the two different follow-up regimens will be explored using a mix of semi-structured open-ended focus group questions.
Contact information is provided by the study sponsor or research team.
Dominique C. Baas, PhD
CONTACT
Lex D. de Jong, PhD
CONTACT
Tergooi Medical Center
Other
How Do Patients and Health Care Professionals Perceive De-implementation of Routine Follow-ups After Total Hip and Knee Arthroplasty? Protocol for a Nested Qualitative Study Within a Hybrid De-implementation Trial
Acronym: HAKA-QUALI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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