Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

Condition(s) targeted: Osteoarthritis

Intervention: Vanguard™ Deep Dish Rotating Platform Knee (Device); Vanguard™ Cruciate Retaining Knee (Device)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Biomet U.K. Ltd.

Official(s) and/or principal investigator(s):
Vikas Vedi, FRCS, Principal Investigator, Affiliation: The Hillingdon Hospital NHS Trust
Ronald Langstaff, FRCS, Principal Investigator, Affiliation: The Hillingdon Hospital NHS Trust

Overall contact:
David Stephenson, Phone: +44 1793 645 229, Email: david.stephenson@biometeurope.com

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

Official title: Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: American Knee Society Score

Secondary outcome:

Patient success as defined in the "Study Definition" section of the protocol

American Knee Society Score

Radiographic Evaluation

Adverse Events

Survivorship

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

David Stephenson, Phone: +44 1793 645 229, Email: david.stephenson@biometeurope.com

The Hillingdon Hospital NHS Trust, Middlesex, United Kingdom

Starting date: September 2008
Ending date: August 2020
Last updated: October 20, 2008