Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
This study is ongoing, but not recruiting participants.
Sponsor:
Biomet, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01010269
First received: October 26, 2009
Last updated: September 14, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis |
Device: Vanguard Complete Knee System w/ std tray Device: Vanguard High Flex RP |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- American Knee Society Knee Score, including ROM [ Time Frame: 1 Year postop ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Kinematic Fluoroscopic Analysis [ Time Frame: 3 yr ] [ Designated as safety issue: No ]
- Gait Lab Analysis [ Time Frame: 3 yr ] [ Designated as safety issue: No ]
- EQ5D [ Time Frame: 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr ] [ Designated as safety issue: No ]
- Radiographic Assessment [ Time Frame: immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2021 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vanguard Complete Knee System w/ std tray |
Device: Vanguard Complete Knee System w/ std tray
Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
|
| Active Comparator: Vanguard High Flex RP |
Device: Vanguard High Flex RP
Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.
|
Detailed Description:
The primary objectives of this clinical study include:
- Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
- Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics in relation to Healthy Knees. o
Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :
- Early ROM
- Clinical outcomes
- Kinetic and Kinematic characteristics
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Painful and disabled knee joint resulting form 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.
- 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:
- Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
- Uncooperative patient or patients 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: NCT01010269
Locations
| Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Biomet, Inc.
Investigators
| Principal Investigator: | Myung-Chul Lee, M.D., Ph.D. | Seoul National University Hospital |
| Principal Investigator: | Chul-Won Ha, M.D., Ph.D. | Samsung Medical Center |
| Principal Investigator: | Seong-Il Bin, M.D., Ph.D. | Asan Medical Center |
| Principal Investigator: | Yong In, M.D., Ph.D. | Catholic University Uijungbu St. Mary's Hospital |
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT01010269 History of Changes |
| Other Study ID Numbers: | ROW1 |
| Study First Received: | October 26, 2009 |
| Last Updated: | September 14, 2012 |
| Health Authority: | Korea: Institutional Review Board |
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 22, 2013