Surgery vs. minimal invasive needle arthroscopy for patients with bacterial knee arthritis

Minimal Invasive Needle Arthroscopy versus Conventional Arthroscopy for Treatment of Bacterial Knee Arthritis – a Pragmatic Randomized Controlled Non-Inferiority Trial (MINA-TRIAL) - Surgery vs. minimal invasive needle arthroscopy for patients with bacterial knee arthritis - an RCT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57912

Enrollment

146

Registered

2025-02-12

Start date

2025-08-20

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

Bacterial knee arthritis, arthritis

Interventions

Bedside minimal invasive needle arthroscopy (MINA)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:At least 18 years old Diagnosed with suspected bacterial arthritis, characterized as a hot, red swollen knee with elevated infection markers (C-reactive protein (CRP), erythrocyte sedimentation rate (BSE), or leukocytes), and turbid/purulent arthrocentesis 

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Patients with a foreign body in the affected joint (e.g., prosthesis, anchor)Traumatic open knee or dislocationPre-existing local osteomyelitis (confirmed with radiology)Knee arthrotomy of the affected joint within the past three monthsBacterial arthritis that affects more than one joint at the moment of inclusionPatients deemed inoperable due to underlying health conditions (e.g., severe cardiovascular or pulmonary disease, advanced malignancy with palliative status)Patients who want only general anesthesia for the interventionPatients who are unable to understand the information (due to a lack of proficiency in English or Dutch) or to provide informed consent, even with the assistance of family or an interpreter.

Design outcomes

Primary

Measure	Time frame
The primary outcome is knee function, assessed by the KOOS-ADL questionnaire, 6 months after initial treatment.	—

Secondary

Measure	Time frame
Cost-effectiveness analysis Functional knee outcomes (the remaining subscales of the KOOS questionnaire) Pain score during rest and activity (NRS score of pain, 0 – 10) Health-related quality of life (EQ-5D-5L)  The number and nature of (serious) adverse events of the intervention The reintervention rate (i.e., MINA, CA, arthrotomy) The need for additional surgery in the affected joint (e.g., joint resection, joint replacement, amputation)  - The length of hospital stayTimeframes of the interventions (e.g., time from the first consultation to intervention and duration of intervention)Patient satisfaction The development of osteoarthritis in the affected knee jointSee section 7.1 of the protocol for a more comprehensive overview	—

Measure

Time frame

Cost-effectiveness analysis Functional knee outcomes (the remaining subscales of the KOOS questionnaire) Pain score during rest and activity (NRS score of pain, 0 – 10) Health-related quality of life (EQ-5D-5L)  The number and nature of (serious) adverse events of the intervention The reintervention rate (i.e., MINA, CA, arthrotomy) The need for additional surgery in the affected joint (e.g., joint resection, joint replacement, amputation)  - The length of hospital stayTimeframes of the interventions (e.g., time from the first consultation to intervention and duration of intervention)Patient satisfaction The development of osteoarthritis in the affected knee jointSee section 7.1 of the protocol for a more comprehensive overview

—

Countries

Netherlands

Contacts

Public ContactL. Steenbekkers

Amsterdam UMC

l.steenbekkers@amsterdamumc.nl+ 31 205667736

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)