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ROSA Robot Used in Total Knee Replacement Post Market Study

Sponsor
Zimmer Biomet (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03969654
Collaborator
(none)
256
Enrollment
5
Locations
2
Arms
44
Anticipated Duration (Months)
51.2
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

Condition or Disease Intervention/Treatment Phase
  • Device: PERSONA Total Knee
  • Device: Vanguard Total Knee
  • Device: NexGen Total Knee
 N/A

Detailed Description

The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Study Design

Study Type:
Interventional
Actual Enrollment :
256 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Robotic Assisted TKA

Robotic Assisted TKA

Device: PERSONA Total Knee
Primary Total Knee Arthroplasty

Device: Vanguard Total Knee
Primary Total Knee Arthroplasty

Device: NexGen Total Knee
Primary Total Knee Arthroplasty
Active Comparator: Conventional TKA

Conventional TKA

Device: PERSONA Total Knee
Primary Total Knee Arthroplasty

Device: Vanguard Total Knee
Primary Total Knee Arthroplasty

Device: NexGen Total Knee
Primary Total Knee Arthroplasty

Outcome Measures

Primary Outcome Measures

  1. Clinical Performance [1 year]

    EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. Oxford Knee Score: The Oxford Knee Score is a patient completed 12 question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 and the maximum score is 48 points.

  2. Workflow Efficiency [1 year]

    Intraoperative questionnaire detailing surgical and OR efficiencies. Operative Time Tourniquet Time Personnel involved/present in OR Knee Alignment Values

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patient is a minimum of 18 years of age

  • Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and 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 IRB or EC approved Informed Consent form

  • Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria:

  • 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 contracture, 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vail-Summit Orthopaedics Vail Colorado United States 81657
2 Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC Westminster Colorado United States 80023
3 SIU School of Medicine Springfield Illinois United States 62702
4 Henry Ford Health System Detroit Michigan United States 48202
5 OrthoVirginia Chippenham North Chesterfield Virginia United States 23225

Sponsors and Collaborators

  • Zimmer Biomet

Investigators

  • Study Director: Kacy Arnold, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT03969654
Other Study ID Numbers:
  • CMU2018-34K
First Posted:
May 31, 2019
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Necrosis

Study Results

No Results Posted as of Jul 16, 2021