Clinical trial NCT06971757: Routine Follow-up at 1 Year After Hip- and Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?
Official title: Cost-effectiveness of Routine Follow-up at One Year After Total Hip and Knee Arthroplasty Compared to Check-up on Demand: a Multicenter Hybrid Stepped-wedge Cluster De-implementation Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Arthroplasty, Total
Knee Arthroplasty, Total
Keywords: total hip arthroplasty
total knee arthroplasty
follow-up
PROMIS physical function
healthcare consumption
Lead sponsor: JointResearch
Sponsor class: OTHER
Collaborators: name: Reinier Haga Orthopedisch Centrum
name: Tergooi MC
First posted: 2025-05-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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 (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.


Eligibility criteria: Inclusion Criteria:

* Painful and disabled hip or knee joint resulting from osteoarthritis
* Scheduled for primary THA or TKA surgery
* Age 50 years or older at the time of THA or TKA
* Capable and willing to complete questionnaires
* Proficient in Dutch or English
* Willing to provide informed consent

Exclusion Criteria:

* Other indication for surgery than osteoarthritis
* Scheduled for hip or knee revision arthroplasty, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
* Already participating in this study due to a previous hip or knee surgery

Primary outcomes:
measure: PROMIS Physical Function
timeFrame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
measure: Number of clinical visits and X-rays
timeFrame: From surgery until 24 months after surgery.
Secondary outcomes:
measure: Number of complications
timeFrame: From surgery until 24 months after surgery.
measure: Type of Complications
timeFrame: From surgery until 24 months after surgery.
measure: Number of surgical interventions
timeFrame: From surgery until 24 months after surgery.
measure: Type of Surgical Interventions
timeFrame: From surgery until 24 months after surgery
measure: Costs related to THA or TKA follow-up
timeFrame: Assessed at 15, 18, and 24 months after surgery.
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
measure: EQ-5D-5L
timeFrame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
Other outcomes:
Locations:
Study officials:
References: