Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

Rheumatoid Arthritis Clinical Trial

— Vanguard  

Official title:

Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01064063
• Other study ID #: BMETEU.CR.LEU29
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2011
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pre-op knee score of <70
• Scheduled to undergo primary total knee replacement with any of the following

indication:

1. pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.

2. 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

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

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.
• AGC knee
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.

Locations

Country	Name	City	State
United Kingdom	East Sussex Hospital NHS Trust	St. Leonards on Sea	East Sussex

Sponsors (3)

Lead Sponsor	Collaborator
Zimmer Biomet	Biomet U.K. Ltd., East Sussex Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Knee Society Knee Score	Objective scoring system to rate the knee and patient's functional abilities before and after TKA	2 year
Secondary	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	2 year
Secondary	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	6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
Secondary	Radiographic evaluation	Assessment of patient x-rays	6m,1y, 2y, 3y, 5y, 10y
Secondary	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.	any
Secondary	Survivorship	Implant survivorship based on removal of a study device.	10 years
Secondary	Noble & Weiss Knee Score, Kujala Score	Scoring systems based on patient questionnaires	6w, 6m, 1y, 2y