Hip Arthroplasty, TotalHAKA 10 yearsNCT07070570
HAKA: Routine Follow-up at 10 Years After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?
A study testing Routine Follow-Up (RFU), Active Check-Up on Demand (ACOD) and Passive Check-Up on Demand (PCOD) in people with Hip Arthroplasty, Total and Knee Arthroplasty, Total, run by Reinier Haga Orthopedisch Centrum at 1 site 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), Active Check-Up on Demand (ACOD) and Passive Check-Up on Demand (PCOD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 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
- Underwent primary THA or TKA approximately 10 years ago
- Age 50 years or older at time of THA or TKA
- Capable and willing to complete questionnaires (when applicable)
- Understanding Dutch or English
- Willing to provide written informed consent in case the patient will complete questionnaires
Who cannot join
- Other indication for surgery than osteoarthritis
- Deceased
- Revision arthroplasty of hip or knee, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
- Already participating in this study due to another hip or knee surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, 2725 NA
J H Pasma, 079-2065595, Onderzoek@rhoc.nl
About this 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 (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.
- Conditions
- Hip Arthroplasty, Total, Knee Arthroplasty, Total
- Being tested
- Routine Follow-Up (RFU), Active Check-Up on Demand (ACOD), Passive Check-Up on Demand (PCOD)
- Keywords
- Routine follow-up, Check-up on demand
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, clinical visit and questionnaires at 10 years after surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Follow-Up (RFU) | Other | Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery Receives: Other: Routine Follow-Up (RFU) |
| 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. Receives: Other: Active Check-Up on Demand (ACOD) |
| 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. Receives: Other: Passive Check-Up on Demand (PCOD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications
The total number of post-operative complications per patient will be recorded.
Measured: 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).
Measured: Assessed until 11 years after implantation
Healthcare consumption
Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits)
Measured: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
Secondary outcomes (9)
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 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2025 (estimated)
- 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.
- 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
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- JointResearch, Tergooi Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070570
- Sponsor's protocol ID
- OC-2024-011
- Acronym
- HAKA 10 years
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 17 Jul 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAKA: Routine Follow-up at 10 Years After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?
- ClinicalTrials.gov ID
- NCT07070570
- Acronym / sponsor ID
- HAKA 10 years / OC-2024-011
- Conditions
- Hip Arthroplasty, Total, Knee Arthroplasty, Total
- Keywords
- Routine follow-up, Check-up on demand
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Collaborators
- JointResearch, Tergooi Medical Center
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Jul 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 (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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Follow-Up (RFU) | Other | Other: Routine Follow-Up (RFU)Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery |
| Active Check-Up on Demand (ACOD) | Other | Other: Active Check-Up on Demand (ACOD)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 | Other: Passive Check-Up on Demand (PCOD)X-ray and clinical visit (without questionnaires) at 10 years after surgery 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 (5 listed)
- Underwent primary THA or TKA approximately 10 years ago
- Age 50 years or older at time of THA or TKA
- Capable and willing to complete questionnaires (when applicable)
- Understanding Dutch or English
- Willing to provide written informed consent in case the patient will complete questionnaires
Key exclusion criteria (4 listed)
- Other indication for surgery than osteoarthritis
- Deceased
- Revision arthroplasty of hip or knee, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
- Already participating in this study due to another 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, clinical visit and questionnaires at 10 years after surgery | Other | Routine Follow-Up (RFU) |
| Active Check-Up on Demand (ACOD)X-ray, clinical visit and questionnaires at 10 years after surgery when requested by the patient or healthcare provider. | Other | Active Check-Up on Demand (ACOD) |
| Passive Check-Up on Demand (PCOD)X-ray and clinical visit (without questionnaires) at 10 year when requested by the patient or healthcare provider. | Other | Passive Check-Up on Demand (PCOD) |
Primary outcome
Number of complications
Time frame: Assessed until 11 years after implantation
The total number of post-operative complications per patient will be recorded.
Type of complications
Time frame: Assessed until 11 years after implantation
Complication types will be recorded and categorized (e.g., infection, periprosthetic fracture, loosening, malalignment, dislocation, prosthetic wear).
Healthcare consumption
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits)
9 secondary outcomes
PROMIS Physical Function
Time frame: Assessed at 10 and 11 years after implantation
Number of surgical interventions
Time frame: Assessed until 11 years after implantation
Type of Surgical Interventions
Time frame: Assessed until 11 years after implantation
Number of additional healthcare consumption
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
Type of additional healthcare consumption
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.
Costs related to THA or TKA follow-up
Time frame: Assessed at 10 years after implantation and then after at 3 months, 6 months and 12 months.
Numeric Pain Rating Scale (NPRS)
Time frame: Assessed at 10 and 11 years after implantation
Numeric Satisfaction Rating Scale (NSRS)
Time frame: Assessed at 10 and 11 years after implantation
Health related quality of life (EQ-5D-5L)
Time frame: Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months
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 17 Jul 2025.
- 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.
1 site 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), Active Check-Up on Demand (ACOD) and Passive Check-Up on Demand (PCOD) in people with Hip Arthroplasty, Total and Knee Arthroplasty, Total, run by Reinier Haga Orthopedisch Centrum at 1 site 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 J. H. Pasma (079-2065595, Onderzoek@rhoc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complications (time frame: Assessed until 11 years after implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.