Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation - Full Text View

Sponsored by:	Biomet U.K. Ltd.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00753090

Purpose

This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.

Condition	Intervention	Phase
Osteoarthritis	Device: Vanguard™ Deep Dish Rotating Platform Knee Device: Vanguard™ Cruciate Retaining Knee	Phase IV

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

American Knee Society Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient success as defined in the "Study Definition" section of the protocol [ Time Frame: 2 years ] [ Designated as safety issue: No ]
American Knee Society Score [ Time Frame: 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years ] [ Designated as safety issue: No ]
Radiographic Evaluation [ Time Frame: 6 weeks, 6 months, annually until all available study patients have completed two-year follow up evaluation and alternating odd years or as needed thereafter up to 10 years ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: Any Time ] [ Designated as safety issue: Yes ]
Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2008
Estimated Study Completion Date:	August 2020
Estimated Primary Completion Date:	August 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.	Device: Vanguard™ Deep Dish Rotating Platform Knee Vanguard™ Deep Dish Rotating Platform Knee
2: Active Comparator This arm utilizes the Vanguard™ Cruciate Retaining Knee.	Device: Vanguard™ Cruciate Retaining Knee Vanguard™ Cruciate Retaining Knee

Detailed Description:

This study is designed to evaluate the safety and efficacy of Vanguard™ Deep Dish Rotating Platform Knee (mobile bearing knee) as compared to Vanguard Cruciate Retaining Knee (fixed bearing knee). This trial will be conducted as the randomised, controlled study.

Implant loosening and polyethylene wear in fixed-bearing knee prostheses were recognized as major causes of late failure. The mobile bearing knee have the theoretical advantages of potentially minimizing the polyethylene wear and reducing implant to bone interface stress in order to reduce the incidence of implant loosening. Therefore, the aims of this study are to prove the Vanguard deep dish rotating platform knee is at least as effective in clinical outcome as the widely used current design of knee replacement and better in long term survivorship.

The efficacy of the device will be determined by the relief of pain, restoration of function and range of motion. The durability of device will be determined by the absence of revision/removal and radiological integrity. To assess the safety of the device, all post operative complications will be recorded either device related or otherwise. Patient satisfaction as determined by answers to patient outcome questionnaires (Oxford Knee Score, WOMAC and Lower Extremity Activity Scale).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a pre-operative knee score of < 70
Patients scheduled to undergo primary total knee replacement with any of the following indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis; One or more compartments are 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:

Absolute contraindications include the following diagnoses:

Patients with a pre-operative knee score of >= 70
Infection
Osteomyelitis
Previous partial or total prosthetic knee replacement on the operative side
Patients who are less than 18 years of age
Sepsis
Patients who had body mass index >= 40

Relative contraindications include the following factors:

Uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis
Metabolic disorders, which may impair bone formation
Osteomalacia
Distant foci of infections, which may spread to the implant site
Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
Vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.
Incomplete or deficient soft tissue surrounding the knee

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753090

Contacts

Contact: David Stephenson

+44 1793 645 229

david.stephenson@biometeurope.com

Locations

United Kingdom
The Hillingdon Hospital NHS Trust
Middlesex, United Kingdom

Sponsors and Collaborators

Biomet U.K. Ltd.

Investigators

Principal Investigator:	Vikas Vedi, FRCS	The Hillingdon Hospital NHS Trust
Principal Investigator:	Ronald Langstaff, FRCS	The Hillingdon Hospital NHS Trust

More Information

Responsible Party:	Biomet U.K. Ltd. ( David Stephenson, Director of Clinical Research )
Study ID Numbers:	EU13A
Study First Received:	September 15, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00753090
Health Authority:	United Kingdom: Research Ethics Committee; Canada: Health Canada

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009