Back to resultsRandomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants (Vanguard)
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Vanguard CR
AGC knee
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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
Sites / Locations
- East Sussex Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
AGC knee
Vanguard CR
Arm Description
Patients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products.
Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics.
Outcomes
Primary Outcome Measures
American Knee Society Knee Score
Objective scoring system to rate the knee and patient's functional abilities before and after TKA
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
American Knee Society Score, Oxford Knee-12, SF-12
Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires
Radiographic evaluation
Assessment of patient x-rays
Adverse Events
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device.
Survivorship
Implant survivorship based on removal of a study device.
Noble & Weiss Knee Score, Kujala Score
Scoring systems based on patient questionnaires
Full Information
NCT ID
NCT01064063
First Posted
February 4, 2010
Last Updated
July 18, 2023
Sponsor
Zimmer Biomet
Collaborators
East Sussex Hospitals NHS Trust, Biomet U.K. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01064063
Brief Title
Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
Acronym
Vanguard
Official Title
Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2011 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
Collaborators
East Sussex Hospitals NHS Trust, Biomet U.K. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study.
The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised into two arms, one receiving the AGC CR cement knee system (control group), and the other receiving Vanguard CR cement knee system (trial group).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGC knee
Arm Type
Active Comparator
Arm Description
Patients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products.
Arm Title
Vanguard CR
Arm Type
Experimental
Arm Description
Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics.
Intervention Type
Device
Intervention Name(s)
Vanguard CR
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
AGC knee
Intervention Description
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
Primary Outcome Measure Information:
Title
American Knee Society Knee Score
Description
Objective scoring system to rate the knee and patient's functional abilities before and after TKA
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Patient success
Description
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
Title
American Knee Society Score, Oxford Knee-12, SF-12
Description
Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires
Time Frame
6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
Title
Radiographic evaluation
Description
Assessment of patient x-rays
Time Frame
6m,1y, 2y, 3y, 5y, 10y
Title
Adverse Events
Description
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device.
Time Frame
any
Title
Survivorship
Description
Implant survivorship based on removal of a study device.
Time Frame
10 years
Title
Noble & Weiss Knee Score, Kujala Score
Description
Scoring systems based on patient questionnaires
Time Frame
6w, 6m, 1y, 2y
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Butler-Manual, FRCS
Organizational Affiliation
East Sussex Hospital NHS Trust - Conquest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Sussex Hospital NHS Trust
City
St. Leonards on Sea
State/Province
East Sussex
ZIP/Postal Code
TN37 7RD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To be confirmed.
Learn more about this trial
Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
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