ROSA Total Knee Post Market Study EMEA

NCT04338893 | Completed Results

• 1 other identifier: CME2019-24K
• Study Type: interventional
• Target: 252
• Locations: 5 countries
• Sites: 6

Brief Summary

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.

Conditions

Chronic Osteoarthritis; Knee Pain; Avascular Necrosis of the Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Alignment Accuracy

  Evaluate the accuracy of implant component alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation, by measuring femoral rotation in the axial plane using pre op and post op CT assessments.

  Pre-operative, 3 months

Secondary Outcomes (10)

• Operative Workflow Efficiency

  Intraoperative

• Oxford Knee Score (OKS)

  Pre-operative, 6 weeks, 3 months, 1 year

• EuroQol 5D (EQ-5D) - Score

  Pre-operative, 6 weeks, 3 months, 1 year

• EuroQol 5D (EQ-5D) VAS Scale

  Pre-operative, 6 weeks, 3 months, 1 year

• NRS (Numeric Rating Scale) Pain

  Pre-operative, 6 weeks, 3 months, 1 year

Study Arms (2)

ROSA Total Knee Robotic Instrumentation

ACTIVE COMPARATOR

Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation

Procedure: Device: Persona Total Knee; Procedure: Device: NexGen Total Knee; Procedure: Device: Vanguard Total Knee

Conventional TKA Instrumentation

ACTIVE COMPARATOR

Total knee arthroplasty performed with conventional instrumentation

Procedure: Device: Persona Total Knee; Procedure: Device: NexGen Total Knee; Procedure: Device: Vanguard Total Knee

Interventions

Device: Persona Total Knee PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice

Conventional TKA Instrumentation; ROSA Total Knee Robotic Instrumentation

Device: NexGen Total Knee PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice

Conventional TKA Instrumentation; ROSA Total Knee Robotic Instrumentation

Device: Vanguard Total Knee PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

Conventional TKA Instrumentation; ROSA Total Knee Robotic Instrumentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patient is a minimum of 18 years of age
• Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or Vanguard knee components implanted in accordance with product labeling
• Patient has participated in this study-related Informed Consent Process
• Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations
• Patient is currently participating in any other surgical intervention studies or pain management studies
• Patient has underwent contralateral UKA or TKA within the last 18 months
• Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
• Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation)
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Herzogin Elisabeth Hospital

Braunschweig, Germany

Location

Evangelisches Waldkrankenhaus Spandau

Spandau, Germany

Location

The Research Fund of Hadassah Medical Organization

Jerusalem, Israel

Location

San Giuseppe Hospital

Arezzo, Italy

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

MeSH Terms

Conditions

Genu Valgum; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chiara Griffoni, Clinical Project Senior Lead
• Organization: Zimmer Biomet

chiara.griffoni@zimmerbiomet.com

+41 79 560 16 28

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: April 8, 2020
• Study Start: December 15, 2020
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); IT (1); CH (1); IL (1); DE (2)