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

Zimmer Biomet

Status: Completed

Conditions: Traumatic Arthritis; Osteoarthritis; Rheumatoid Arthritis

Treatments: Device: AGC knee; Device: Vanguard CR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01064063

NCT01064063 (Registry Identifier)

BMETEU.CR.LEU29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

AGC knee

Active Comparator group

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.

Treatment:

Device: AGC knee

Vanguard CR

Experimental group

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.

Treatment:

Device: Vanguard CR