Vanguard CR vs. AGC
This study is currently recruiting participants.
Verified January 2013 by Biomet, Inc.
Sponsor:
Biomet, Inc.
Collaborators:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01064063
First received: February 4, 2010
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR)to evaluate clinical efficacy of the Vanguard CR components.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis |
Device: Vanguard CR Device: AGC knee |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- American Knee Society Knee Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient success (defined as Knee Score greater than or equal to 80, No component revisions or removals, No pending component revisions or removals, Absence of osteolysis, No migration/subsidence of >3mm or >3 degrees) [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- American Knee Society Score, Oxford Knee-12, SF-12 [ Time Frame: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y ] [ Designated as safety issue: No ]
- Radiographic evaluation [ Time Frame: 6m,1y, 2y, 3y, 5y, 10y ] [ Designated as safety issue: Yes ]
- Adverse Events [ Time Frame: any ] [ Designated as safety issue: Yes ]
- Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Noble & Weiss Knee Score, Kujala Score [ Time Frame: 6w, 6m, 1y, 2y ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2023 |
| Estimated Primary Completion Date: | February 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: AGC knee |
Device: AGC knee
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
|
| Experimental: Vanguard CR |
Device: Vanguard CR
The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.
|
Detailed Description:
This clinical trial is designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use.
The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pre-op knee score of <70
Scheduled to undergo primary total knee replacement with any of the following indication:
- pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
- One or more compartments involved.
- Need to obtain pain relief and improve function
- Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
- A good nutritional state of the patient
- Full skeletal maturity of the patient, patients who are at least 18 years of age.
- Patients of either sex
- Consent form read, understood, and signed by patient
Exclusion Criteria:
- Pre-op knee score greater than or equal to 70
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Skeletal immaturity of the patient, patients who are less than 18 years of age.
- Sepsis
- Uncooperative patient or patient with neurological disorders who are incapable of following directions
- Osteomalacia
- Distant foci of infections
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb
- Incomplete or deficient soft tissue surrounding the knee
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064063
Locations
| United Kingdom | |
| East Sussex Hospital NHS Trust | Recruiting |
| St. Leonards on Sea, East Sussex, United Kingdom, TN37 7RD | |
| Contact: Nigel Ellens (01424) 755255 ext +44 | |
| Contact: Kim Miles | |
| Norfolk and Norwich University Hospital | Withdrawn |
| Norwich, Middlesex, United Kingdom, NR4 7UY | |
Sponsors and Collaborators
Biomet, Inc.
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Biomet U.K. Ltd.
Investigators
| Principal Investigator: | Charles Mann, FRCS | Norfolk and Norwich University Hospital NHS Trust |
| Principal Investigator: | A. Butler-Manual, FRCS | East Sussex Hospital NHS Trust |
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT01064063 History of Changes |
| Other Study ID Numbers: | EU39 |
| Study First Received: | February 4, 2010 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United Kingdom: National Health Service |
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