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HAKA trial 1 year follow-up

Routine follow-up at 1 year after Hip- And Knee Arthroplasty (HAKA): wasting resources or appropriate healthcare? - HAKA trial 1 year FU

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57594
Enrollment
1000
Registered
2025-02-06
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip and/or knee osteoarthritis Wear and tear of hip and/or knee joints

Interventions

Study population: Patients scheduled for THA or TKA who experience pain and disability in the knee or hip joint due to osteoarthritis, and aged = 50 years at the time of the surgery.Intervention:&nbsp
Check-up on demand (COD) by the patient or healthcare provider (HCP), after a final clinical visit &nbsp
within 3 months to diagnose complications and provide instructions when to contact an HCP.Comparator: Routine follow up (RFU) consisting of an&nbsp
X-ray and clinical visit within 3 months and at 1 year after surgery. Patients are welcome to contact an HCP in case of pain, concerns or other symptoms associated with their prosthesis at any time.

Sponsors

OLVG
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Painful and disabled hip or knee joint resulting from osteoarthritisScheduled for primary THA or TKA surgeryAge 50 years or older at the time of THA or TKACapable and willing to complete questionnairesProficient in Dutch or EnglishWilling to provide informed consent

Exclusion criteria

Exclusion criteria: Other indication for surgery than osteoarthritisScheduled for hip or knee revision arthroplasty, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THAScheduled for a bilateral operationAlready participating in this study due to a previous hip or knee surgery

Design outcomes

Primary

MeasureTime frame
The main study parameters are clinical and process outcomes. The clinical outcome is patient-reported physical function, measured with the PROMIS questionnaire, 2 years after surgery (1 year after RFU or COD). The process outcome is healthcare consumption, including X-rays, clinical visits, and diagnostic tests.

Secondary

MeasureTime frame
Number and type of complications (e.g. infection, peri-prosthetic fracture, loosening, malalignment or malposition of components, prosthetic wear, dislocation, etc.)Number and type of surgical interventions (e.g. DAIR, partial component exchange, revision surgery (full prosthesis replacement), irrigation and debridement (without component retention), etc.)Additional healthcare consumption related to THA or TKA FU (e.g. clinical visit, telephone consultations, X-ray, CT scan, MRI scan, laboratory tests, other)Health related quality of life (EQ-5D-5L)Numeric Pain Rating Scale (NPRS)Numeric Satisfaction Rating Scale (NSRS)Costs (based on electronic patient records and additional questionnaires, including all visits to healthcare providers outside the hospital)

Countries

Netherlands

Contacts

Public ContactL.A.C. Roubos

OLVG

jointresearch@olvg.nl020 599 2415

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026