Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| JointResearch | OTHER |
| Tergooi Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Follow-Up (RFU) | Other | Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery |
|
| Active Check-Up on Demand (ACOD) | Other | Follow-up care with X-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 | X-ray and clinical visit (without questionnaires) at 10 years after surgery when requested by the patient or healthcare provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Follow-Up (RFU) | Other | Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications | The total number of post-operative complications per patient will be recorded. | 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). | Assessed until 11 years after implantation |
| Healthcare consumption | Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits) | Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J. H. Pasma | Contact | 079-2065595 | Onderzoek@rhoc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reinier Haga Orthopedisch Centrum | Zoetermeer | South Holland | 2725 NA | Netherlands |
De-identified individual participant data (IPD) that underlie the results reported in publications (e.g., PROMs, healthcare consumption, complications) will be made available upon reasonable request. Metadata will be openly accessible with a persistent identifier.
IPD and supporting information will be available beginning 6 months after publication of the main results and will remain available for at least 5 years thereafter.
Researchers who provide a methodologically sound proposal and agree to a data use agreement will be granted access to de-identified IPD and selected supporting documents. Requests can be submitted to the corresponding author or data access contact. Access is conditional on approval by the study team.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Check-Up on Demand (ACOD) | Other | X-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 | X-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider. |
|
| 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. | 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). | 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) | 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) | 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. | 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. | 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. | 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 | Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months |