A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System

NCT ID: NCT01906177

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-07-31

Brief Summary

The primary objectives of this pilot clinical study include:

• Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population
• Evaluate safety of Vanguard PS Total Knee in Korean population

Detailed Description

This study is a prospective, single cohort, multi-center study of Vanguard PS system and will be conducted in Korea with 2 institutions. The study will be conducted over a period of 10 years. Patients will be followed at immediate post-op, 6 weeks, 6 months and 1 year, 3 years.

Total of 2 sites will be involved in this study. 50 cases on each sites and total of 100 subjects will be enrolled in the study.

Primary end-point will be KSS at 1 year post op and secondary end-points are Survivorship of the product, KSS, EQ5D, High-Flexion Knee Score, Radiographic Assessment, and any kind of complication including lost to follow up.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Posttraumatic Deformity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
• Need to obtain pain relief and improve function
• Ability and willingness of the patient to follow instructions, including control of weight and activity level
• A good nutritional state of the patient, and
• The patient must have reached full skeletal maturity (at least 18 years old).

Exclusion Criteria

• infection
• sepsis
• osteomyelitis
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions
• Osteoporosis
• 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, neuromuscular disease
• Incomplete or deficient soft tissue surrounding the knee

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young Joon Choi, PHD

Role: PRINCIPAL_INVESTIGATOR

Gangneung Asan Hospital

Jong Keun Seon, PHD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Locations

Gangneung Asan Hospital

Gangneung-Si, Gangwon-do, South Korea

Chonnam National University Hwasun Hospital

Jeongnam, Jeollanam-do, South Korea

Countries

South Korea

Other Identifiers

INT.CR.GK5

Identifier Type: -

Identifier Source: org_study_id