Implementing Robot-assisted knee arthroplasty at a high-volume, peripheral hospital

Implementing Robot-assisted knee arthroplasty at a high-volume, peripheral hospital - ROSA_IMP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51307

Enrollment

Registered

2022-02-04

Start date

2022-03-02

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Arthrosis Osteoarthrosis

Interventions

Use or Not-use of an surgery-plan, developed usingt he ROSA-software

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Eligible for primary TKA * age 40-90 years * Body-Mass-Index 18.5-50.0 kg/m2 * American Society of Anaesthesiologists Class I-III * Willingness and capability to understand and follow protocol

Exclusion criteria

Exclusion criteria: * Rheuma-/trauma-indicated knee arthroplasty

Design outcomes

Primary

Measure	Time frame
Operation ward occupation duration (exit patient #0 to exit patient #1, with patient #0 having no TKA or comparable procedure, and patient #1 being operated with ROSA), preparation duration (entry patient to incision), and duration of surgery (incision to end of surgery).	—

Secondary

Measure	Time frame
Logistical Outcomes: Coordination with anaesthesia/recovery ward, number of instrument trays used, number of cases until Zimmer-Biomet support is no longer needed, type of previous and following surgery. Operation ward occupation duration for stand-alone ROSA-procedures (prior and consequent surgeries in ward are not TKAs), and for consequent TKA- or ROSA-procedures. Procedural Outcomes: Accuracy of surgical plan (#adaptations, #procedures without deviations from plan) including alignment (deviation, #outliers), implant size, and level of resection. Perioperative outcomes include #complications, blood loss, length of hospital stay, medication, use of anaesthesia, analgesia. ROSA outcomes include stability, implant position, mobility, mechanical axis of the leg (data analysed at end of OR procedure). Clinical Outcomes: 90-day survival implant, survival patient, reason for revision, type of revision, complications, Oxford Knee Score, Knee Society Score, European Quality of Life Questionnaire 5-Dimensions-5L, Visual Analogue Scale for pain, Pain Catastrophizing Scale, Pain Sensitivity Questionnaire	—

Measure

Time frame

Logistical Outcomes: Coordination with anaesthesia/recovery ward, number of instrument trays used, number of cases until Zimmer-Biomet support is no longer needed, type of previous and following surgery. Operation ward occupation duration for stand-alone ROSA-procedures (prior and consequent surgeries in ward are not TKAs), and for consequent TKA- or ROSA-procedures. Procedural Outcomes: Accuracy of surgical plan (#adaptations, #procedures without deviations from plan) including alignment (deviation, #outliers), implant size, and level of resection. Perioperative outcomes include #complications, blood loss, length of hospital stay, medication, use of anaesthesia, analgesia. ROSA outcomes include stability, implant position, mobility, mechanical axis of the leg (data analysed at end of OR procedure). Clinical Outcomes: 90-day survival implant, survival patient, reason for revision, type of revision, complications, Oxford Knee Score, Knee Society Score, European Quality of Life Questionnaire 5-Dimensions-5L, Visual Analogue Scale for pain, Pain Catastrophizing Scale, Pain Sensitivity Questionnaire

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026