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 (WP1) investigates the 1-year follow-up, WP2 examines the 10-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
1,000
Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery.
Follow-up care with scheduled X-ray and clinical visit at 3 months and only at 1 year if requested.
OLVG
Amsterdam, Netherlands
RECRUITINGAmphia
Breda, Netherlands
RECRUITINGDeventer Ziekenhuis
Deventer, Netherlands
RECRUITINGAdmiraal de Ruyter Ziekenhuis
Goes, Netherlands
RECRUITINGMartini Ziekenhuis
Groningen, Netherlands
RECRUITINGTergooi MC
Hilversum, Netherlands
RECRUITINGCanisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
RECRUITINGZorgSaam Zeeuws Vlaanderen
Terneuzen, Netherlands
RECRUITINGRHOC
Zoetermeer, Netherlands
RECRUITINGPROMIS 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 before surgery and at 3, 12, 15, 18, and 24 months after surgery.
Number of clinical visits and X-rays
Assesses healthcare consumption based on the number of postoperative outpatient clinical visits and X-ray assessments.
Time frame: From surgery until 24 months after surgery.
Number of complications
The total number of post-operative complications per patient will be recorded.
Time frame: From surgery until 24 months after surgery.
Type of Complications
Complication types will be recorded and categorized (e.g., infection, periprosthetic fracture, loosening, malalignment, dislocation, prosthetic wear).
Time frame: From surgery until 24 months after surgery.
Number of surgical interventions
The total number of surgical re-interventions per patient related to the index procedure will be recorded.
Time frame: From surgery until 24 months after surgery.
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: From surgery until 24 months after surgery
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 15, 18, and 24 months after surgery.
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 before surgery and at 3, 12, 15, 18, and 24 months after surgery.
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 before surgery and at 3, 12, 15, 18, and 24 months after surgery.
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