HAKA: Routine Follow-up at 10 Years After Hip- or Knee Arthroplasty: Wasting Resources or Appropriate Healthcare?

NCT07070570 | Not Yet Recruiting

• 1 other identifier: OC-2024-011
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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 (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

Keywords

Routine follow-up; Check-up on demand

Outcome Measures

Primary Outcomes (3)

• Number of complications

  The total number of post-operative complications per patient will be recorded.

  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).

  Assessed until 11 years after implantation

• Healthcare consumption

  Healthcare consumption related to THA and TKA FU (number of X-rays and clinical visits)

  Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.

Secondary Outcomes (9)

• PROMIS Physical Function

  Assessed at 10 and 11 years after implantation

• Number of surgical interventions

  Assessed until 11 years after implantation

• Type of Surgical Interventions

  Assessed until 11 years after implantation

• Number of additional healthcare consumption

  Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.

• Type of additional healthcare consumption

  Assessed at 10 years after implantation and then at 3 months, 6 months and 12 months.

Study Arms (3)

Routine Follow-Up (RFU)

OTHER

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)

OTHER

Follow-up care with 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)

OTHER

X-ray and clinical visit (without questionnaires) at 10 years after surgery when requested by the patient or healthcare provider.

Other: Passive Check-Up on Demand (PCOD)

Interventions

Routine Follow-Up (RFU) OTHER

Standard follow-up care with scheduled X-ray, clinical visit and questionnaires at 10 years after surgery

Routine Follow-Up (RFU)

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.

Active Check-Up on Demand (ACOD)

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.

Passive Check-Up on Demand (PCOD)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum: lead
• JointResearch: collaborator
• Tergooi Medical Center: collaborator

Study Sites (1)

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, 2725 NA, Netherlands

Location

Central Study Contacts

J. H. Pasma

CONTACT

079-2065595; Onderzoek@rhoc.nl

Study Design

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

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 17, 2025

Record last verified: 2025-07

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 (1)