Vanguard XP Early Clinical Evaluation Protocol

Overview

Status: Enrolling by invitation
Keywords: Total Hip Replacement (THA) , Joint Replacement , Hip Revision
IRB Number: 00066089
Specialty: Joint Replacement, Joint Replacement
Sub Specialties: Knee Replacement

Brief Summary

PURPOSES
1. Assess candidacy for Bicruciate Knee Arthroplasty from all knee replacement patients during a scheduled period of time.
2. Evaluate operative room time of surgical technique and assess complication / readmission rate.
3. Evaluate patient perceived clinical outcomes through 2-year standard of care follow-up.

Principal Investigator: Chris Pelt
Department: Orthopedic Surgery
Co Investigator: Christopher Peters
Co Investigator: Jill Erickson

Contact Information

Name:Michael Anderson
Phone: 801-213-3442
Email: mike.anderson@hsc.utah.edu

Inclusion Criteria

Group A. 

Will assess all patients who present with a need for joint replacement arthroplasty to determine whether disease state is indicated for partial, Bicruciate retaining, or total knee replacement. These patients will be treated according to surgeon preference at each center. Only minimal information on this data set will be collected.

Group B. 

Patients who receive the cemented Vanguard XP BiCruciate Knee System based on meeting indications for use, and inclusion / exclusion criteria described in the protocol.

Inclusion Criteria:

Subjects will be considered to be included in this trial if they satisfy all of the following criteria:
Meet the FDA cleared indications for use:
  • Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis or traumatic arthritis where one or more compartments are involved.
  • Correction of varus, valgus, or posttraumatic deformity
  • Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of a previous joint replacement procedure.

The FDA has cleared the following components as indicated, but for purposes of this study we will only include cemented component fixation to limit variables:

  • Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended for uncemented biologic fixation application.

Exclusion Criteria

Group B Exclusions:

Contraindicated for use in individuals with: 

1. Infection

2. Sepsis

3. Osteomyelitis

Relative contraindications include:

1. Uncooperative patients or patient with neurologic disorders who is incapable of following directions

2. Osteoporosis

3. Metabolic Disorders which may impair bone formation

4. Osteomalacia

5. Rapid joint destruction, marked bone loss or bone resportion apparent on roentgenram

    Vascular insufficiency, muscular atrophy, neuromuscular disease

6. Incomplete or deficient soft tissue surrounding the knee