Hip Arthroplasty, TotalHAKA-QUALINCT07041528
Perceptions of De-implementing Routine Follow-ups After Hip and Knee Arthroplasty
An observational study of Hip Arthroplasty, Total and Knee Arthroplasty, Total, run by Tergooi Medical Center 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 guidelines. 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
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2026to 1 Jun 2028
- Phase
- Observational
- 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
Study population: * Patients after total hip or knee arthroplasty who are enrolled in work package 1 or work package 2 of the main HAKA trial. * Health care professionals who have cared for at least 3 participants from the RFU or COD groups enrolled in work package 1 or work package 2 of the main HAKA trial.
Who may be able to join
- A good command of the Dutch language
Who cannot join
- N/A
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
Tergooi MC
Hilversum
Dominique C. Baas, PhD, 0031(0)0887535153, dbaas@tergooi.nl
About this study
Official title: How Do Patients and Health Care Professionals Perceive De-implementation of Routine Follow-ups After Total Hip and Knee Arthroplasty? Protocol for a Nested Qualitative Study Within a Hybrid De-implementation 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 guidelines. 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).The quantitative work packages 1 (WP1) and 2 (WP2) will investigate the 1-year and 10-year follow-up. The qualitative third work package (WP3) will explore and compare the patients' and health care professionals' (HCPs) experiences with, and perceptions about, RFU and COD after total hip and knee arthroplasty. The aim of the overarching 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
- Keywords
- Aftercare, Arthroplasty, Focus Groups, Hip, Interview [Publication Type], Knee, Osteoarthritis, Patient Acceptance of Health Care, Qualitative Research
- Medical subject headings
- Osteoarthritis, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine Follow-up (RFU) | Patients planned for total hip or knee surgery who will receive routinely scheduled follow-ups. | |
| Check-ups on-demand (COD) | Patients planned for total hip or knee surgery who will receive check-ups on-demand. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The participants' experiences with their follow-up regimen.
The participants' experiences will be explored using a mix of semi-structured open-ended focus group questions.
Measured: Experiences gained between the baseline clinical visit and a clinical visit one year later.
The participants' satisfaction with their follow-up regimen.
The participants' satisfaction will be explored using a mix of semi-structured open-ended focus group questions.
Measured: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.
The health care professionals' experiences with the different follow-up regimens.
The health care professionals' experiences will be explored using a mix of semi-structured open-ended interview questions.
Measured: Experiences gained between the baseline clinical visit and a clinical visit one year later.
The health care professionals' satisfaction with the different follow-up regimens.
The health care professionals' satisfaction will be explored using a mix of semi-structured open-ended interview questions.
Measured: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.
The participants' and health care professionals' acceptability of the two different follow-up regimens.
The participants' and health care professionals' acceptability of the two different follow-up regimens will be explored using a mix of semi-structured open-ended focus group questions.
Measured: Acceptability of follow-up regimens from the baseline clinical visit to a clinical visit one year later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tergooi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Reinier Haga Orthopedisch Centrum, JointResearch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041528
- Sponsor's protocol ID
- N25.014
- Other IDs
- 10330042310003
- Acronym
- HAKA-QUALI
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Supporting data-including an overview of all themes, original Dutch quotes from focus groups and interviews, and their English translations-will be compiled in a table and made openly available via an online data repository.
Publications
Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
PubMed 17964352Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.
PubMed 30496082Christensen M, Folkmar K. No clinical value of post-operative routine X-ray following uncomplicated cementless primary total hip arthroplasty. Dan Med J. 2013 Apr;60(4):A4613.
PubMed 23651720Hart AA, DeMik DE, Brown TS, Noiseux NO. Routine Radiographs After Total Joint Arthroplasty: Is There Clinical Value? J Arthroplasty. 2021 Jul;36(7):2431-2434. doi: 10.1016/j.arth.2021.02.050. Epub 2021 Feb 24.
PubMed 33714635Dargel J, Oppermann J, Bruggemann GP, Eysel P. Dislocation following total hip replacement. Dtsch Arztebl Int. 2014 Dec 22;111(51-52):884-90. doi: 10.3238/arztebl.2014.0884.
PubMed 25597367Blom AW, Beswick AD, Burston A, Carroll FE, Garfield K, Gooberman-Hill R, Harris S, Kunutsor SK, Lane A, Lenguerrand E, MacGowan A, Mallon C, Moore AJ, Noble S, Palmer CK, Rolfson O, Strange S, Whitehouse MR. Infection after total joint replacement of the hip and knee: research programme including the INFORM RCT [Internet]. Southampton (UK): National Institute for Health and Care Research; 2022 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK587029/
PubMed 36469653Lindeque B, Hartman Z, Noshchenko A, Cruse M. Infection after primary total hip arthroplasty. Orthopedics. 2014 Apr;37(4):257-65. doi: 10.3928/01477447-20140401-08.
PubMed 24762833Schwartz AM, Farley KX, Guild GN, Bradbury TL Jr. Projections and Epidemiology of Revision Hip and Knee Arthroplasty in the United States to 2030. J Arthroplasty. 2020 Jun;35(6S):S79-S85. doi: 10.1016/j.arth.2020.02.030. Epub 2020 Feb 19.
PubMed 32151524Kunutsor SK, Barrett MC, Beswick AD, Judge A, Blom AW, Wylde V, Whitehouse MR. Risk factors for dislocation after primary total hip replacement: a systematic review and meta-analysis of 125 studies involving approximately five million hip replacements. Lancet Rheumatol. 2019 Oct;1(2):e111-e121. doi: 10.1016/S2665-9913(19)30045-1. Epub 2019 Sep 9.
PubMed 38229338Cassidy RS, O hEireamhoin S, Beverland DE. Guidelines for the follow-up of total hip arthroplasty: do they need to be revised? Bone Joint J. 2019 May;101-B(5):536-539. doi: 10.1302/0301-620X.101B5.BJJ-2018-0853.R2.
PubMed 31038998Lovelock TM, Broughton NS. Follow-up after arthroplasty of the hip and knee : are we over-servicing or under-caring? Bone Joint J. 2018 Jan;100-B(1):6-10. doi: 10.1302/0301-620X.100B1.BJJ-2017-0779.R1.
PubMed 29305444Smith LK, Dures E, Beswick AD. Systematic review of the clinical effectiveness for long-term follow-up of total hip arthroplasty. Orthop Res Rev. 2019 Jul 2;11:69-78. doi: 10.2147/ORR.S199183. eCollection 2019.
PubMed 31308766American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee Evidence-Based Clinical Practice Guideline. 2022
Broughton N, Lovelock T, De Steiger R, Page R, Donnelly B, Solomon M, et al. Arthroplasty Society of Australia guidelines for long term follow-up of joint replacement patients. 2019
Federatie Medisch Specialisten. Total hip prosthesis (THP). 2019
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Do Patients and Health Care Professionals Perceive De-implementation of Routine Follow-ups After Total Hip and Knee Arthroplasty? Protocol for a Nested Qualitative Study Within a Hybrid De-implementation Trial
- ClinicalTrials.gov ID
- NCT07041528
- Acronym / sponsor ID
- HAKA-QUALI / N25.014
- Conditions
- Hip Arthroplasty, Total, Knee Arthroplasty, Total
- Keywords
- Aftercare, Arthroplasty, Focus Groups, Hip, Interview [Publication Type], Knee, Osteoarthritis, Patient Acceptance of Health Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tergooi Medical CenterUniversity, hospital or other
- Collaborators
- Reinier Haga Orthopedisch Centrum, JointResearch
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 27 Jun 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 guidelines. 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).The quantitative work packages 1 (WP1) and 2 (WP2) will investigate the 1-year and 10-year follow-up. The qualitative third work package (WP3) will explore and compare the patients' and health care professionals' (HCPs) experiences with, and perceptions about, RFU and COD after total hip and knee arthroplasty. The aim of the overarching 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Follow-up (RFU) | – | –Patients planned for total hip or knee surgery who will receive routinely scheduled follow-ups. |
| Check-ups on-demand (COD) | – | –Patients planned for total hip or knee surgery who will receive check-ups on-demand. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients after total hip or knee arthroplasty who are enrolled in work package 1 or work package 2 of the main HAKA trial. * Health care professionals who have cared for at least 3 participants from the RFU or COD groups enrolled in work package 1 or work package 2 of the main HAKA trial.
Key inclusion criteria (1 listed)
- A good command of the Dutch language
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The participants' experiences with their follow-up regimen.
Time frame: Experiences gained between the baseline clinical visit and a clinical visit one year later.
The participants' experiences will be explored using a mix of semi-structured open-ended focus group questions.
The participants' satisfaction with their follow-up regimen.
Time frame: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.
The participants' satisfaction will be explored using a mix of semi-structured open-ended focus group questions.
The health care professionals' experiences with the different follow-up regimens.
Time frame: Experiences gained between the baseline clinical visit and a clinical visit one year later.
The health care professionals' experiences will be explored using a mix of semi-structured open-ended interview questions.
The health care professionals' satisfaction with the different follow-up regimens.
Time frame: Perceived satisfaction between the baseline clinical visit and a clinical visit one year later.
The health care professionals' satisfaction will be explored using a mix of semi-structured open-ended interview questions.
The participants' and health care professionals' acceptability of the two different follow-up regimens.
Time frame: Acceptability of follow-up regimens from the baseline clinical visit to a clinical visit one year later.
The participants' and health care professionals' acceptability of the two different follow-up regimens will be explored using a mix of semi-structured open-ended focus group questions.
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 27 Jun 2025.
- Background: PubMed 17964352Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
- Background: PubMed 30496082Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.
- Background: PubMed 23651720Christensen M, Folkmar K. No clinical value of post-operative routine X-ray following uncomplicated cementless primary total hip arthroplasty. Dan Med J. 2013 Apr;60(4):A4613.
- Background: PubMed 33714635Hart AA, DeMik DE, Brown TS, Noiseux NO. Routine Radiographs After Total Joint Arthroplasty: Is There Clinical Value? J Arthroplasty. 2021 Jul;36(7):2431-2434. doi: 10.1016/j.arth.2021.02.050. Epub 2021 Feb 24.
- Background: PubMed 25597367Dargel J, Oppermann J, Bruggemann GP, Eysel P. Dislocation following total hip replacement. Dtsch Arztebl Int. 2014 Dec 22;111(51-52):884-90. doi: 10.3238/arztebl.2014.0884.
- Background: PubMed 36469653Blom AW, Beswick AD, Burston A, Carroll FE, Garfield K, Gooberman-Hill R, Harris S, Kunutsor SK, Lane A, Lenguerrand E, MacGowan A, Mallon C, Moore AJ, Noble S, Palmer CK, Rolfson O, Strange S, Whitehouse MR. Infection after total joint replacement of the hip and knee: research programme including the INFORM RCT [Internet]. Southampton (UK): National Institute for Health and Care Research; 2022 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK587029/
- Background: PubMed 24762833Lindeque B, Hartman Z, Noshchenko A, Cruse M. Infection after primary total hip arthroplasty. Orthopedics. 2014 Apr;37(4):257-65. doi: 10.3928/01477447-20140401-08.
- Background: PubMed 32151524Schwartz AM, Farley KX, Guild GN, Bradbury TL Jr. Projections and Epidemiology of Revision Hip and Knee Arthroplasty in the United States to 2030. J Arthroplasty. 2020 Jun;35(6S):S79-S85. doi: 10.1016/j.arth.2020.02.030. Epub 2020 Feb 19.
- Background: PubMed 38229338Kunutsor SK, Barrett MC, Beswick AD, Judge A, Blom AW, Wylde V, Whitehouse MR. Risk factors for dislocation after primary total hip replacement: a systematic review and meta-analysis of 125 studies involving approximately five million hip replacements. Lancet Rheumatol. 2019 Oct;1(2):e111-e121. doi: 10.1016/S2665-9913(19)30045-1. Epub 2019 Sep 9.
- Background: PubMed 31038998Cassidy RS, O hEireamhoin S, Beverland DE. Guidelines for the follow-up of total hip arthroplasty: do they need to be revised? Bone Joint J. 2019 May;101-B(5):536-539. doi: 10.1302/0301-620X.101B5.BJJ-2018-0853.R2.
- Background: PubMed 29305444Lovelock TM, Broughton NS. Follow-up after arthroplasty of the hip and knee : are we over-servicing or under-caring? Bone Joint J. 2018 Jan;100-B(1):6-10. doi: 10.1302/0301-620X.100B1.BJJ-2017-0779.R1.
- Background: PubMed 31308766Smith LK, Dures E, Beswick AD. Systematic review of the clinical effectiveness for long-term follow-up of total hip arthroplasty. Orthop Res Rev. 2019 Jul 2;11:69-78. doi: 10.2147/ORR.S199183. eCollection 2019.
- Published information about HAKA-trial work package 1Link provided by the sponsor.
- Published information about HAKA-trial work package 2Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Supporting data-including an overview of all themes, original Dutch quotes from focus groups and interviews, and their English translations-will be compiled in a table and made openly available via an online data repository.
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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?
An observational study of Hip Arthroplasty, Total and Knee Arthroplasty, Total, run by Tergooi Medical Center 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 1 inclusion and 1 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 27 Jun 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 Dominique C. Baas, PhD (0031-(0)887535153, dbaas@tergooi.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The participants' experiences with their follow-up regimen. (time frame: Experiences gained between the baseline clinical visit and a clinical visit one year later.). The study lists 5 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 NCT07041528, which also lists 55 linked publications.
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 27 Jun 2025.