NCT03664791

Brief Summary

The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
4 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2009

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 10, 2024

Status Verified

June 1, 2023

Enrollment Period

15.2 years

First QC Date

September 6, 2018

Last Update Submit

April 9, 2024

Conditions

Osteoarthritis, KneeRheumatoid ArthritisTraumatic ArthritisPosttraumatic DeformityVarus DeformityValgus DeformityOsteotomyArthrodesis

Outcome Measures

Primary Outcomes (1)

  • Functional outcomes assessment

    The American Knee Society Clinical Rating System (original method) : Evaluation of the knee joint and functional assessment of patients. Subscale knee assessment: judgement of pain (50 points), stability (25 points)and range of motion (25 points (5 degrees is 1 point). Flexion contracture, extension lag and malalignment should be dealt with as deductions. Maximum Knee score of 100 points. Subscale functional assessment: assessment of patient function for walking distance (50 points)and stair climbing (50points), with deductions for walking aids. Maximum Function score is 100 points.

    10 years

Secondary Outcomes (4)

  • Radiographic outcomes assessment

    10 years

  • Assesment of health-related quality of life using the EQ-5D score

    10 years

  • Safety and performance of the device by recording all adverse events

    10 years

  • Calculation of survivorship using revision of prosthesis as the failure event

    10 years

Study Arms (1)

Vanguard Rocc knee implant

Patient in need for a total knee arthroplasty and who met the inclusion/ exclusion criteria and received the Vanguard Rocc implant

Procedure: Vanguard Rocc

Interventions

Vanguard RoccPROCEDURE

Patient operated with the Vanguard Rocc knee prosthesis

Vanguard Rocc knee implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in need of a total knee arthroplasty which receive the Vanguard Rocc knee device and who meet all of the inclusion and none of the exclusion criteria

You may qualify if:

  • System specifically:
  • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  • Correction of varus, valgus, or posttraumatic deformity.
  • Correction or revision of unsuccessful osteotomy, or arthrodesis.
  • Male or female.
  • years of age or older
  • Subjects willing to return for follow-up evaluations

You may not qualify if:

  • Relative contraindications include:
  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  • Osteoporosis,
  • Metabolic disorders which may impair bone formation,
  • Osteomalacia,
  • Distant foci of infections which may spread to the implant site,
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
  • Vascular insufficiency, muscular atrophy, neuromuscular disease,
  • Incomplete or deficient soft tissue surrounding the knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

ZNA Jan Palfijn

Merksem, Belgium

Location

Sydvestjysk Hospital

Grindsted, Denmark

Location

Hvidovre University Hospital

Hvidovre, Denmark

Location

Clinique Pasteur

Guilherand-Granges, France

Location

Clinique des Fontaines

Melun, France

Location

Clinique d'Argonayy

Pringy, France

Location

Clinique d'Argonay

Pringy, France

Location

Clinique du Renaison

Roanne, France

Location

South West London Elective Orthopaedic centre - EPSOM General Hospital

Epsom, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, KneeArthritis, RheumatoidAnkylosis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paola Vivoda

    Zimmer Biomet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 11, 2018

Study Start

October 23, 2009

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

April 10, 2024

Record last verified: 2023-06

Locations

FR(5)BE(1)DK(2)GB(1)