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

NCT01064063 | Completed

• 2 other identifiers: BMETEU.CR.LEU29NCT01064063
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• American Knee Society Knee Score

  Objective scoring system to rate the knee and patient's functional abilities before and after TKA

  2 year

Secondary Outcomes (6)

• Patient success

  2 year

• American Knee Society Score, Oxford Knee-12, SF-12

  6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y

• Radiographic evaluation

  6m,1y, 2y, 3y, 5y, 10y

• Adverse Events

  any

• Survivorship

  10 years

Study Arms (2)

AGC knee

ACTIVE COMPARATOR

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.

Device: AGC knee

Vanguard CR

EXPERIMENTAL

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.

Device: Vanguard CR

Interventions

Vanguard CR DEVICE

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.

Vanguard CR

AGC knee DEVICE

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

AGC knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead
• East Sussex Hospitals NHS Trust: collaborator
• Biomet U.K. Ltd.: collaborator

Study Sites (1)

East Sussex Hospital NHS Trust

Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• A. Butler-Manual, FRCS

  East Sussex Hospital NHS Trust - Conquest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: February 15, 2011
• Primary Completion: December 15, 2013
• Study Completion: May 10, 2022
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)