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

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01064063
• Collaborator: East Sussex Hospitals NHS Trust (Other), Biomet U.K. Ltd. (Industry)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 147.5
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis	Device: Vanguard CR; Device: AGC knee	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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).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: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
• Actual Study Start Date: Feb 15, 2011
• Actual Primary Completion Date: Sep 15, 2014
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AGC knee 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; The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
Experimental: Vanguard CR 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; 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.

Outcome Measures

Primary Outcome Measures

1. American Knee Society Knee Score [2 year]

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

Secondary Outcome Measures

1. Patient success [2 year]

   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. American Knee Society Score, Oxford Knee-12, SF-12 [6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y]

   Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires

3. Radiographic evaluation [6m,1y, 2y, 3y, 5y, 10y]

   Assessment of patient x-rays

4. Adverse Events [any]

   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.

5. Survivorship [10 years]

   Implant survivorship based on removal of a study device.

6. Noble & Weiss Knee Score, Kujala Score [6w, 6m, 1y, 2y]

   Scoring systems based on patient questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Sussex Hospital NHS Trust	St. Leonards on Sea	East Sussex	United Kingdom	TN37 7RD

Sponsors and Collaborators

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

Investigators

• Principal Investigator: A. Butler-Manual, FRCS, East Sussex Hospital NHS Trust - Conquest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT01064063
• Other Study ID Numbers: BMETEU.CR.LEU29
• First Posted: Feb 8, 2010
• Last Update Posted: Mar 8, 2022
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis

Study Results

No Results Posted as of Mar 8, 2022