Status:
COMPLETED
A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01906177
Start Date
July 1 2012
End Date
July 1 2017
Last Update
June 26 2018
Active Locations (2)
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1
Gangneung Asan Hospital
Gangneung-Si, Gangwon-do, South Korea, 210-711
2
Chonnam National University Hwasun Hospital
Jeongnam, Jeollanam-do, South Korea, 519-809