ACTIVE_NOT_RECRUITING

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

Official Title

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Quick Facts

Study Start:2012-03
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT01542580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  2. * Correction of varus, valgus or post-traumatic deformity
  3. * Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
  4. * Ability and willingness of the patient to attend follow-up visit.
  5. * Willing to give written informed consent
  6. * Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.
  1. * infection
  2. * sepsis
  3. * osteomyelitis
  4. * An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
  5. * Osteoporosis
  6. * Metabolic disorders which may impair brain function
  7. * Osteomalacia
  8. * Distant foci of infections which may spread to the implant site
  9. * Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
  10. * Vascular insufficiency, muscular atrophy, neuromuscular disease
  11. * Incomplete or deficient soft tissue surrounding the knee

Contacts and Locations

Principal Investigator

Emilie Rohmer
STUDY_DIRECTOR
Zimmer Biomet

Study Locations (Sites)

Illinois Bone and Joint
Morton Grove, Illinois, 60053
United States
Orthopedic Institute of Henderson
Henderson, Nevada, 89052
United States
University of Utah Orthopedic Center
Salt Lake City, Utah, 84108
United States
OrthoVirginia West End Orthopedic Clinic
Richmond, Virginia, 23235
United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

  • Emilie Rohmer, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-03
Study Completion Date2031-12

Study Record Updates

Study Start Date2012-03
Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

  • Revision surgery

Additional Relevant MeSH Terms

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Post Traumatic Deformity
  • Complications; Arthroplasty
  • Deformity of Limb