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| ID | Type | Description | Link |
|---|---|---|---|
| 10330042310003 | Other Grant/Funding Number | ZonMw |
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| Name | Class |
|---|---|
| Reinier Haga Orthopedisch Centrum | OTHER |
| Tergooi MC | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Follow-Up (RFU) | Other | X-ray and clinical visit within 3 months and at 1 year after surgery. |
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| Check-Up on Demand (COD) | Other | X-ray and clinical visit within 3 months and only at 1 year when requested by the patient or healthcare provider. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Follow-Up (RFU) | Other | Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery. |
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| 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. | 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. | From surgery until 24 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications | The total number of post-operative complications per patient will be recorded. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lidy A.C. Roubos, MSc. | Contact | +31 20 599 3653 | L.A.C.Roubos@olvg.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG | Recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41843589 | Derived | Rasker AJ, Roubos LAC, Baas DC, Verhagen RAW, de Jong LD, Rutgers M, Vorrink SNW, Pasma JH, Poolman RW, Willigenburg NW. Is check-up on demand non-inferior to routine follow-up at one year after total hip or knee arthroplasty in terms of clinical outcomes and cost-effectiveness? Protocol for a randomized stepped-wedge hybrid effectiveness de-implementation trial. PLoS One. 2026 Mar 17;21(3):e0343627. doi: 10.1371/journal.pone.0343627. eCollection 2026. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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This is a hybrid effectiveness (de-)implementation trial type II, with a stepped-wedge cluster trial design. A total of 10 hospitals will transition from a period with RFU to a period with COD, with a wash-out period (transition) of 2 months. The aim is to gradually de-implement RFU, with all centers eventually using COD as the standard of care.
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| Check-Up on Demand (COD) | Other | Follow-up care with scheduled X-ray and clinical visit at 3 months and only at 1 year if requested. |
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| 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. | 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). | 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. | 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. | 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. | Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery. |
| Amphia | Recruiting | Breda | Netherlands |
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| Deventer Ziekenhuis | Recruiting | Deventer | Netherlands |
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| Admiraal de Ruyter Ziekenhuis | Recruiting | Goes | Netherlands |
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| Martini Ziekenhuis | Recruiting | Groningen | Netherlands |
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| Tergooi MC | Recruiting | Hilversum | Netherlands |
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| Canisius Wilhelmina Ziekenhuis | Recruiting | Nijmegen | Netherlands |
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| ZorgSaam Zeeuws Vlaanderen | Recruiting | Terneuzen | Netherlands |
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| RHOC | Recruiting | Zoetermeer | Netherlands |
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