Clinical trial NCT05685693: ROSA Knee System vs Conventional Total Knee Arthroplasty
Official title: The Effect of ROSA®-Assisted Knee Arthroplasty on Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Robotic-assisted arthroplasty
Knee arthroplasty
Gait
Metabolic Syndrome
ROSA Knee System
Physical Activity
Cost-effectiveness
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2023-01-17
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical study, in which 150 patients with end-stage osteoarthritis will be enrolled to ROSA®-assisted knee arthroplasty or conventional knee arthroplasty. Patients are recruited at Zuyderland Medical Center, enrolled pre-operatively and followed up for 12 months post-surgery. In- and exclusion criteria are stated below.

After recruitment, participants will be invited for a pre-operative visit. During this pre-operative visit Informed Consent is signed and completion of patient-reported outcome measures (PROMs) is checked. Additionally, measurements regarding body composition, strength and fitness and metabolic outcomes are performed. Participants will have a blood sample taken. Scans, adverse event and medication use will be confirmed. Participants will receive a ActiGraph for collecting data from physical activity. Of all patients, 72 will undergo additional measurements (gait, proprioception).

During surgery ROSA- and surgery-data will be collected. Post-operative participants will have a 6-weeks, 3-month and 12-month visit. During these visits pre-operative measurements are repeated.


Eligibility 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:

- Rheuma-/trauma-indicated knee arthroplasty

Primary outcomes:
measure: Oxford Knee Score
timeFrame: 3-months post-operative
measure: Oxford Knee Score
timeFrame: 12-months post-operative
Secondary outcomes:
measure: Quality of Life-Index
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Symptoms
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Pain Catastrophizing
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Pain Sensitivity
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Mobility
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Complications
timeFrame: During in-patient stay for indicated surgery (up to 5 days)
measure: Duration of surgery
timeFrame: During surgery
measure: Blood loss
timeFrame: During surgery
measure: Length of hospital stay
timeFrame: During in-patient stay for indicated surgery (up to 5 days)
measure: Anesthesia
timeFrame: During surgery
measure: Stability of the knee
timeFrame: Immediately after the surgery
measure: Knee implant position
timeFrame: Immediately after the surgery
measure: Mobility of the knee
timeFrame: During and immediately after the surgery
measure: Mechanical axis of the leg.
timeFrame: 3-months post-surgery
measure: Implant Survival
timeFrame: 90-day and 1-year
measure: Patient Survival
timeFrame: 90-day and 1-year
measure: Physical Activity
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Metabolic Syndrome
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Body composition
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Handgrip strength
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Physical condition
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Physical strength
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Physical mobility
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Cost of procedure, implants
timeFrame: During Surgery
measure: Cost of procedure, personnel
timeFrame: During Surgery
measure: Productivity
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Medical consumption
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Work Ability Index
timeFrame: Pre-operative, 3-months and 12-months post-operative.
measure: Work Productivity and Activity Impairment
timeFrame: Pre-operative, 3-months and 12-months post-operative.
Other outcomes:
measure: Gait, walking
timeFrame: Pre-operative, 12-months post-operative
measure: Gait, sit-to-stand
timeFrame: Pre-operative, 12-months post-operative
measure: Gait, single-leg-stance
timeFrame: Pre-operative, 12-months post-operative
measure: Proprioception, reaction time
timeFrame: Pre-operative, 12-months post-operative
measure: Proprioception, angle at movement
timeFrame: Pre-operative, 12-months post-operative
Locations:
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
Study officials:
affiliation: Zuyderland Medical Center
name: Jasper Most, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zuyderland Medical Center
name: Bert Boonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: