Hip Arthroplasty, TotalHAKA 1year FUNCT06971757
HAKA: Routine Follow-Up at 1 Year After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?
A study testing Routine Follow-Up (RFU) and Check-Up on Demand (COD) in people with Hip Arthroplasty, Total and Knee Arthroplasty, Total, run by JointResearch at 9 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Arthroplasty, Total, Knee Arthroplasty, Total
- What is being tested?
- Routine Follow-Up (RFU) and Check-Up on Demand (COD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 9 sitesNetherlands
- Study dates
- 1 Jul 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Netherlands9 sites, 9 recruiting
- Recruiting
OLVG
Amsterdam
Prof. Poolman, +31 20 510 8911, R.W.Poolman@olvg.nl
- Recruiting
Amphia
Breda
Van Oost, MSc., +31 76 595 5000, Ivanoost@amphia.nl
- Recruiting
Deventer Ziekenhuis
Deventer
Dr. Kleinlugtenbelt, +31 570 535 353, Y.Kleinlugtenbelt@dz.nl
- Recruiting
Admiraal de Ruyter Ziekenhuis
Goes
Dr. Colo, +31 88 125 0000, D.colo@adrz.nl
- Recruiting
Martini Ziekenhuis
Groningen
Dr. Kuiper, +31 50 524 5245, Jesse.kuiper@mzh.nl
- Recruiting
Tergooi MC
Hilversum
Dr. Verhagen, +31 88 753 1753, Rverhagen@tergooi.nl
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
Kremers, MSc., +31 24 365 7657, K.kremers@cwz.nl
- Recruiting
ZorgSaam Zeeuws Vlaanderen
Terneuzen
M. van de Kerkhove, +31 115 688 000, M.vandekerkhove@zzv.nl
- Recruiting
RHOC
Zoetermeer
Dr. Pasma, +31 79 206 55 00, J.Pasma@rhoc.nl
About this study
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
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.
- Conditions
- Hip Arthroplasty, Total, Knee Arthroplasty, Total
- Being tested
- Routine Follow-Up (RFU), Check-Up on Demand (COD)
- Keywords
- total hip arthroplasty, total knee arthroplasty, follow-up, PROMIS physical function, healthcare consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Follow-Up (RFU)Other
Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery.
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Follow-Up (RFU) | Other | X-ray and clinical visit within 3 months and at 1 year after surgery. Receives: Other: Routine Follow-Up (RFU) |
| 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. Receives: Other: Check-Up on Demand (COD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From surgery until 24 months after surgery.
Secondary outcomes (7)
Number of complications
The total number of post-operative complications per patient will be recorded.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jul 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Arthroplasty, TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Collaborators
- Reinier Haga Orthopedisch Centrum, Tergooi MC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971757
- Sponsor's protocol ID
- NL-009246
- Other IDs
- 10330042310003
- Acronym
- HAKA 1year FU
- Status last verified
- Nov 2025
- First submitted
- 6 May 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41843589
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06971757
- Acronym / sponsor ID
- HAKA 1year FU / NL-009246
- Conditions
- Hip Arthroplasty, Total, Knee Arthroplasty, Total
- Keywords
- total hip arthroplasty, total knee arthroplasty, follow-up, PROMIS physical function, healthcare consumption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Collaborators
- Reinier Haga Orthopedisch Centrum, Tergooi MC
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Routine Follow-Up (RFU) | Other | Other: Routine Follow-Up (RFU)X-ray and clinical visit within 3 months and at 1 year after surgery. |
| Check-Up on Demand (COD) | Other | Other: Check-Up on Demand (COD)X-ray and clinical visit within 3 months and only at 1 year when requested by the patient or healthcare provider. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Follow-Up (RFU)Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery. | Other | Routine Follow-Up (RFU) |
| Check-Up on Demand (COD)Follow-up care with scheduled X-ray and clinical visit at 3 months and only at 1 year if requested. | Other | Check-Up on Demand (COD) |
Primary outcome
PROMIS Physical Function
Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
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.
Number of clinical visits and X-rays
Time frame: From surgery until 24 months after surgery.
Assesses healthcare consumption based on the number of postoperative outpatient clinical visits and X-ray assessments.
7 secondary outcomes
Number of complications
Time frame: From surgery until 24 months after surgery.
Type of Complications
Time frame: From surgery until 24 months after surgery.
Number of surgical interventions
Time frame: From surgery until 24 months after surgery.
Type of Surgical Interventions
Time frame: From surgery until 24 months after surgery
Costs related to THA or TKA follow-up
Time frame: Assessed at 15, 18, and 24 months after surgery.
Numeric Pain Rating Scale (NPRS)
Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
EQ-5D-5L
Time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 41843589Rasker 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Follow-Up (RFU) and Check-Up on Demand (COD) in people with Hip Arthroplasty, Total and Knee Arthroplasty, Total, run by JointResearch at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lidy A.C. Roubos, MSc. (+31 20 599 3653, L.A.C.Roubos@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Physical Function (time frame: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.