HAKA: Routine Follow-Up at 1 Year After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorJointResearch
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Routine Follow-Up (RFU)
Other interventionStandard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery.
Check-Up on Demand (COD)
Other interventionFollow-up care with scheduled X-ray and clinical visit at 3 months and only at 1 year if requested.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Routine Follow-Up (RFU)Other 1 intervention
Group B: Check-Up on Demand (COD)Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.2
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.Secondary outcomes
1
Number of complications
The total number of post-operative complications per patient will be recorded.
Time frame
From surgery until 24 months after surgery.2
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.3
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.4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov