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

Completed

• Conditions: Posttraumatic Deformity; Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis

• Registration Number: NCT01906177
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-24
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American Knee Society Score	1 year Post Op	Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop

Secondary Outcome Measures

Name	Time	Method
Survivorship	3 years post op	To access the number of patients with implants
EQ-5D	3 year post op	Quality of life on patients
Radiographic Assessment	3 year Post Op	Access on subsidence, migration, and radiolucency
Complications	3 year Post Op	Any AEs to patients

Trial Locations

Locations (2)

Gangneung Asan Hospital; 🇰🇷 Gangneung-Si, Gangwon-Do, Korea, Republic of

Chonnam National University Hwasun Hospital; 🇰🇷 Jeongnam, Jeonnam, Korea, Republic of