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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906177
• Other study ID #: INT.CR.GK5
• Status: Completed
• Start date: July 2012
• Est. completion date: July 2017

Study information

• Verified date: June 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Posttraumatic Deformity
• Rheumatoid Arthritis
• Traumatic Arthritis

Locations

Country	Name	City	State
Korea, Republic of	Gangneung Asan Hospital	Gangneung-Si	Gangwon-Do
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeongnam	Jeonnam

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Knee Society Score	Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop	1 year Post Op
Secondary	Survivorship	To access the number of patients with implants	3 years post op
Secondary	EQ-5D	Quality of life on patients	3 year post op
Secondary	Radiographic Assessment	Access on subsidence, migration, and radiolucency	3 year Post Op
Secondary	Complications	Any AEs to patients	3 year Post Op