Clinical trial NCT01010269: Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
Official title: A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.

Detailed description: The primary objectives of this clinical study include:

* Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
* Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
* Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:

  * Early ROM
  * Clinical outcomes
  * Kinetic and Kinematic characteristics in relation to Healthy Knees. o
* Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :

  * Early ROM
  * Clinical outcomes
  * Kinetic and Kinematic characteristics

Eligibility criteria: Inclusion Criteria:

* Painful and disabled knee joint resulting form 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, or arthrodesis.
* Need to obtain pain relief and improve function.
* Ability and willingness of the patient to follow instructions, including control of weight and activity level.
* Good nutritional state of the patient.
* Patient must have reached full skeletal maturity.

Exclusion Criteria:

* Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
* Uncooperative patient or patients 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 Knee Score
timeFrame: 1 Year postop
Secondary outcomes:
measure: Kinematic Fluoroscopic Analysis
timeFrame: 3 yr
measure: Gait Lab Analysis
timeFrame: 3 yr
measure: EQ5D
timeFrame: 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
measure: Radiographic Assessment
timeFrame: immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Nat'l Uni. Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Uni. of Korea, Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Myung-Chul Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Chul-Won Ha, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Seong-Il Bin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University Uijungbu St. Mary's Hospital
name: Yong In, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: