Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments vanguard™ deep dish rotating platform knee, vanguard™ cruciate retaining knee
Phase phase 4
Sponsor Biomet U.K. Ltd.
Start date June 2009
End date August 2021
Trial size 329 participants
Trial identifier NCT00753090, BMETEU.CR.EU13A

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This arm utilizes the Vanguard™ Deep Dish Rotating Platform Knee.
vanguard™ deep dish rotating platform knee
Vanguard™ Deep Dish Rotating Platform Knee
(Active Comparator)
This arm utilizes the Vanguard™ Cruciate Retaining Knee.
vanguard™ cruciate retaining knee
Vanguard™ Cruciate Retaining Knee

Primary Outcomes

Measure
American Knee Society Score
time frame: 2 years

Secondary Outcomes

Measure
Patient success as defined in the "Study Definition" section of the protocol
time frame: 2 years
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
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
Adverse Events
time frame: Any Time
Survivorship
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
Principal investigator Vikas Vedi, FRCS
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..