The effect of ROSA-assisted knee arthroplasty on clinical outcomes

The effect of ROSA-assisted knee arthroplasty on clinical outcomes - ROSA RCT

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56362

Enrollment

150

Registered

2022-09-19

Start date

2022-12-16

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Arthrosis Osteoarthrosis

Interventions

ROSA-assisted knee arthroplasty vs conventional knee arthroplasty

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
to compare improvement in arthrosis symptoms between patients operated with ROSA-assistance and conventionally operated patients one year after surgery	—

Secondary

Measure	Time frame
Patient-reported outcome measures (PROMs), including OKS, EUR5D-5L, WOMAC, Pain Catastrophizing Scale, Pain Sensitivity Questionnaire will be collected through Phillips Vital Health, as explained in 8.1.1. Surgical outcomes include #complications, duration of surgery, blood loss, length of hospital stay, medication, anesthesia, analgesia and are documented in the surgery report and available through SAP. Stability, implant position, mobility, mechanical axis of the leg will be extracted from the ROSA-software. Accuracy of surgical plan (#adaptations, #procedures without deviations from plan) including implant size and level of resection and documented during surgery using the ROSA-software. Logistic outcomes of surgery include surgery ward occupation duration including preparation, operation duration (incision to bandage), anaesthesia, transition from one patient to next, and is collected through the BOZIS-system of Zuyderland Medical Center. Clinical outcomes include alignment of the leg, 90-day and 1-year survival implant and survival patient, reason for revision, type of revision will be retrieved from electronic medical chart abstraction (SAP NetWeaver for Windows 10, V760 Final Release). Alignment (deviation, #outliers) will be assessed before TKA and 3 months after surgery using a CT scan, per (pre-operative) routine practice . Physical activity and weight bearing will be assessed for 7 continuous days using hip-worn accelerometers. Metabolic outcomes include metabolic syndrome, body composition and handgrip strength. Metabolic syndrome will be quantified binary or as continuous scale. Binary classification will be performed per present AHA/NHLBI ATPIII-criteria: at least 3 out of 5 measures: • waist circumference >=102 cm in men or >=88 cm in women; • triglycerides: >=150 mg/dL (1.7 mmol/L), or on drug treatment for elevated triglycerides; • HDL-Cholesterol: =130 mm Hg systolic blood pressure, >=85 mm Hg diastolic blood pressure,	—

Measure

Time frame

Patient-reported outcome measures (PROMs), including OKS, EUR5D-5L, WOMAC, Pain Catastrophizing Scale, Pain Sensitivity Questionnaire will be collected through Phillips Vital Health, as explained in 8.1.1. Surgical outcomes include #complications, duration of surgery, blood loss, length of hospital stay, medication, anesthesia, analgesia and are documented in the surgery report and available through SAP. Stability, implant position, mobility, mechanical axis of the leg will be extracted from the ROSA-software. Accuracy of surgical plan (#adaptations, #procedures without deviations from plan) including implant size and level of resection and documented during surgery using the ROSA-software. Logistic outcomes of surgery include surgery ward occupation duration including preparation, operation duration (incision to bandage), anaesthesia, transition from one patient to next, and is collected through the BOZIS-system of Zuyderland Medical Center. Clinical outcomes include alignment of the leg, 90-day and 1-year survival implant and survival patient, reason for revision, type of revision will be retrieved from electronic medical chart abstraction (SAP NetWeaver for Windows 10, V760 Final Release). Alignment (deviation, #outliers) will be assessed before TKA and 3 months after surgery using a CT scan, per (pre-operative) routine practice . Physical activity and weight bearing will be assessed for 7 continuous days using hip-worn accelerometers. Metabolic outcomes include metabolic syndrome, body composition and handgrip strength. Metabolic syndrome will be quantified binary or as continuous scale. Binary classification will be performed per present AHA/NHLBI ATPIII-criteria: at least 3 out of 5 measures: • waist circumference >=102 cm in men or >=88 cm in women; • triglycerides: >=150 mg/dL (1.7 mmol/L), or on drug treatment for elevated triglycerides; • HDL-Cholesterol: =130 mm Hg systolic blood pressure, >=85 mm Hg diastolic blood pressure,

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)