About this trial
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 guideline. 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). This trial (WP2) investigates the 10-year follow-up, WP1 examines the 1-year follow-up, and WP3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. The aim of the HAKA trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Underwent primary THA or TKA approximately 10 years ago
Age 50 years or older at time of THA or TKA
Capable and willing to complete questionnaires (when applicable)
Understanding Dutch or English
Disqualifiers
Other indication for surgery than osteoarthritis
Deceased
Revision arthroplasty of hip or knee, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
Already participating in this study due to another hip or knee surgery
Trial design
Parallel
Treatments tested in this trial
Routine Follow-Up (RFU)
Other interventionStandard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery
Active Check-Up on Demand (ACOD)
Other interventionX-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.
Passive Check-Up on Demand (PCOD)
Other interventionX-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider.
Treatment groups
Trial outcomes
Primary outcomes
Number of complications
The total number of post-operative complications per patient will be recorded.
Type of complications
Complication types will be recorded and categorized (e.g., infection, periprosthetic fracture, loosening, malalignment, dislocation, prosthetic wear).
Healthcare consumption
Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits)
Secondary outcomes
PROMIS Physical Function
Patient-reported physical functioning will be assessed using the PROMIS® Physical Function Version 1.0, Short Form 10a. The short form consists of 10 items and is expressed by raw summed score ranging from 10 to 50, which can be converted to a T-score and SE. The T-score is a standardized score with a mean of 50 and a SD of 10. Higher T-scores indicate better physical functioning
Number of surgical interventions
The total number of surgical re-interventions per patient related to the index procedure will be recorded.
Type of Surgical Interventions
Types of surgical re-interventions will be recorded and categorized (e.g., DAIR, partial component exchange, full revision, irrigation and debridement without component retention).
Number of additional healthcare consumption
Number of additional healthcare consumption related to THA or TKA FU (like clinical visit, telephone consultations, X-ray, CT scan, MRI scan, laboratory tests)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Reinier Haga Orthopedisch Centrum
Lead sponsor
JointResearch
Collaborator
Tergooi Medical Center
Collaborator
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