Hip Arthroplasty, Total, Knee Arthroplasty, Total
Conditions
Keywords
Routine follow-up, Check-up on demand
Brief summary
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.
Interventions
Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery
OTHERActive Check-Up on Demand (ACOD)
X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider.
OTHERPassive Check-Up on Demand (PCOD)
X-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider.
Sponsors
JointResearch
Tergooi Medical Center
Reinier Haga Orthopedisch Centrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Willing to provide written informed consent in case the patient will complete questionnaires
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of complications | Assessed until 11 years after implantation | The total number of post-operative complications per patient will be recorded. |
| Type of complications | Assessed until 11 years after implantation | Complication types will be recorded and categorized (e.g., infection, periprosthetic fracture, loosening, malalignment, dislocation, prosthetic wear). |
| Healthcare consumption | Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months. | Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of additional healthcare consumption | Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months. | Number of additional healthcare consumption related to THA or TKA FU (like clinical visit, telephone consultations, X-ray, CT scan, MRI scan, laboratory tests) |
| Type of additional healthcare consumption | Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months. | Type of additional healthcare consumption related to THA or TKA FU (like clinical visit, telephone consultations, X-ray, CT scan, MRI scan, laboratory tests) |
| Costs related to THA or TKA follow-up | Assessed at 10 years after implantation and then after at 3 months, 6 months and 12 months. | Includes costs from electronic health records and additional patient questionnaires, covering hospital and non-hospital care. |
| PROMIS Physical Function | Assessed at 10 and 11 years after implantation | 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 |
| Numeric Satisfaction Rating Scale (NSRS) | Assessed at 10 and 11 years after implantation | 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. |
| Health related quality of life (EQ-5D-5L) | Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months | 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 |
| Numeric Pain Rating Scale (NPRS) | Assessed at 10 and 11 years after implantation | 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. |
| Number of surgical interventions | Assessed until 11 years after implantation | The total number of surgical re-interventions per patient related to the index procedure will be recorded. |
| Type of Surgical Interventions | Assessed until 11 years after implantation | Types of surgical re-interventions will be recorded and categorized (e.g., DAIR, partial component exchange, full revision, irrigation and debridement without component retention). |
Countries
Netherlands
Contacts
Primary ContactJ. H. Pasma
Outcome results
None listed