A Clinical Investigation of the Vanguard™ Complete Knee System
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Biomet Orthopedics, Inc. Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Clinical Research, Biomet Orthopedics, Inc.
Summary
The purpose of this prospective clinical data-collection is to document the performance and
clinical outcomes of the Vanguard™ Complete Knee System.
Clinical Details
Official title: A Prospective, Non-Controlled, Clinical Investigation of the Vanguard™ Complete Knee System
Study design: Cohort, Prospective
Primary outcome: Knee Society Score
Secondary outcome: X-rays
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- 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.
Patient selection factors to be considered include:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions
- Including control of weight and activity level
- Good nutritional state of the patient
- Patient must have reached full skeletal maturity.
Exclusion criteria:
Absolute contraindications include:
- Infection
- Sepsis
- Osteomyelitis
- Failure of a previous joint replacement.
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.
Locations and Contacts
Additional Information
Starting date: March 2004
Ending date: December 2013
Last updated: June 13, 2008
|
