Clinical trial NCT01906177: A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System
Official title: A Prospective Munti-center Study on VANGUARD™ PS Total Knee Replacement System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Posttraumatic Deformity
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total 100 cases

each site of 6 sites delegated to enroll 50 cases each

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.

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

Primary outcomes:
measure: American Knee Society Score
timeFrame: 1 year Post Op
Secondary outcomes:
measure: Survivorship
timeFrame: 3 years post op
measure: EQ-5D
timeFrame: 3 year post op
measure: Radiographic Assessment
timeFrame: 3 year Post Op
measure: Complications
timeFrame: 3 year Post Op
Other outcomes:
Locations:
city: Gangneung-Si
country: Korea, Republic of
facility: Gangneung Asan Hospital
state: Gangwon-Do
city: Jeongnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
Study officials:
affiliation: Gangneung Asan Hospital
name: Young Joon Choi, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Jong Keun Seon, PHD
role: PRINCIPAL_INVESTIGATOR
References: