HAKA: Routine Follow-Up at 1 Year After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?

NCT06971757 | Recruiting

• 2 other identifiers: NL-00924610330042310003
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Hip Arthroplasty, Total; Knee Arthroplasty, Total

Keywords

total hip arthroplasty; total knee arthroplasty; follow-up; PROMIS physical function; healthcare consumption

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From surgery until 24 months after surgery.

Secondary Outcomes (7)

• Number of complications

  From surgery until 24 months after surgery.

• Type of Complications

  From surgery until 24 months after surgery.

• Number of surgical interventions

  From surgery until 24 months after surgery.

• Type of Surgical Interventions

  From surgery until 24 months after surgery

• Costs related to THA or TKA follow-up

  Assessed at 15, 18, and 24 months after surgery.

Study Arms (2)

Routine Follow-Up (RFU)

OTHER

X-ray and clinical visit within 3 months and at 1 year after surgery.

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.

Other: Check-Up on Demand (COD)

Interventions

Routine Follow-Up (RFU) OTHER

Standard follow-up care with scheduled X-ray and clinical visit at 3 months and 1 year after surgery.

Routine Follow-Up (RFU)

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.

Check-Up on Demand (COD)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JointResearch: lead
• Reinier Haga Orthopedisch Centrum: collaborator
• Tergooi MC: collaborator

Study Sites (9)

OLVG

Amsterdam, Netherlands

RECRUITING

Amphia

Breda, Netherlands

RECRUITING

Deventer Ziekenhuis

Deventer, Netherlands

RECRUITING

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, Netherlands

RECRUITING

Tergooi MC

Hilversum, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

ZorgSaam Zeeuws Vlaanderen

Terneuzen, Netherlands

RECRUITING

RHOC

Zoetermeer, Netherlands

RECRUITING

Related Links

• Related Info

Central Study Contacts

Lidy A.C. Roubos, MSc.

CONTACT

+31 20 599 3653; L.A.C.Roubos@olvg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available beginning 6 months after publication of the main results and will remain available for at least 5 years thereafter.
• Access Criteria: Researchers who provide a methodologically sound proposal and agree to a data use agreement will be granted access to de-identified IPD and selected supporting documents. Requests can be submitted to the corresponding author or data access contact. Access is conditional on approval by the study team.

Locations

NL (9)