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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,500
Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery
X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.
X-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider.
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, Netherlands
Number of complications
The total number of post-operative complications per patient will be recorded.
Time frame: Assessed until 11 years after implantation
Type of complications
Complication types will be recorded and categorized (e.g., infection, periprosthetic fracture, loosening, malalignment, dislocation, prosthetic wear).
Time frame: Assessed until 11 years after implantation
Healthcare consumption
Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits)
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
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
Time frame: Assessed at 10 and 11 years after implantation
Number of surgical interventions
The total number of surgical re-interventions per patient related to the index procedure will be recorded.
Time frame: Assessed until 11 years after implantation
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).
Time frame: Assessed until 11 years after implantation
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)
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
Type of additional healthcare consumption
Type of additional healthcare consumption related to THA or TKA FU (like clinical visit, telephone consultations, X-ray, CT scan, MRI scan, laboratory tests)
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
Costs related to THA or TKA follow-up
Includes costs from electronic health records and additional patient questionnaires, covering hospital and non-hospital care.
Time frame: Assessed at 10 years after implantation and then after at 3 months, 6 months and 12 months.
Numeric Pain Rating Scale (NPRS)
Patient-reported pain intensity, measured using a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores reflect more severe pain.
Time frame: Assessed at 10 and 11 years after implantation
Numeric Satisfaction Rating Scale (NSRS)
Numeric Rating Scale for satisfaction (NSRS) will be measured by a single question: "How satisfied are you with the results of the treatment?" The patient will answer this question with a NRS scale ranging from zero to ten. The higher the score, the better.
Time frame: Assessed at 10 and 11 years after implantation
Health related quality of life (EQ-5D-5L)
Health-related quality of life is measured using the EQ-5D-5L questionnaire. The EQ-5D-5L index score ranges from -0.594 to 1.000, where 1.000 indicates full health, 0 represents death, and negative values represent health states worse than death. Higher scores indicate better health status
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months
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