A Clinical Investigation of the Vanguard™ Complete Knee System
This study is enrolling participants by invitation only.
Sponsor:
Biomet, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00698854
First received: June 13, 2008
Last updated: October 15, 2012
Last verified: October 2012
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Purpose
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
| Condition |
|---|
|
Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- KSS [ Time Frame: 10 year ] [ Designated as safety issue: No ]Knee Society Score Assessment
Secondary Outcome Measures:
- X-Ray Data [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | January 2022 |
| Estimated Primary Completion Date: | January 2022 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Vanguard™ Complete Knee System
Vanguard™ Complete Knee System
|
Detailed Description:
This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, impo, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device.
The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients in need of relief from painful or disabling joint disease
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698854
Locations
| United States, Iowa | |
| Physicians Clinic of Iowa Orthopedics | |
| Cedar Rapids, Iowa, United States, 52403 | |
| United States, Maryland | |
| The Orthopaedic Center | |
| Rockville, Maryland, United States, 20850 | |
| United States, New York | |
| Orthopaedic Associates of Rochester | |
| Rochester, New York, United States, 14626 | |
| United States, Texas | |
| Texas Orthopedic Specialists | |
| Grapevine, Texas, United States, 76015 | |
| United States, Virginia | |
| Orthopedic Associates | |
| Fishersville, Virginia, United States, 22939 | |
| United States, Washington | |
| Spokane Orthopedics | |
| Spokane, Washington, United States, 99207 | |
| United States, Wisconsin | |
| Othopaedic & Sports Medicine Clinic of Monroe | |
| Monroe, Wisconsin, United States, 53566 | |
Sponsors and Collaborators
Biomet, Inc.
Investigators
| Study Director: | Russell A Schenck, Ph.D. | Clinical Research, Biomet, Inc. |
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT00698854 History of Changes |
| Other Study ID Numbers: | Biomet 13594-53 |
| Study First Received: | June 13, 2008 |
| Last Updated: | October 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biomet, Inc.:
|
Total Knee Arthroplasty Total Knee Replacement Knee Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Osteoarthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013