NIPH Clinical Trials Search

UMIN ID: UMIN000021279

Registered date:02/03/2016

Randomized controlled study comparing Vanguard with KneeAlign2 navigational system versus Vanguard conventional

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedKnee Joint Diseases
Date of first enrollment2016/05/17
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Vanguard with KneeAlign 2 as investigational group. Vanguard with conventional instrumentation and without KneeAlign 2 as control group.


Primary OutcomeProportion of subjects that have alignment within 2 degrees from neutral on tibia at postoperative 6 months.
Secondary OutcomeSurgery time, Tibial posterior slope alignment, Femoral varus/valgus angle, frequency to perform re-osteotomy for angle correction with KneeAlign2, and collection of adverse events/ adverse device effects

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria- Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis) - Severe OA deformation (FTA:> 185 degrees / < 175 degrees) - Active Infection (or within 6 weeks after infection) - Sepsis - Osteomyelitis - Any type of implant is inserted in the affected side of lower extremity - Hip disease on the affected side - Uncooperative patient or patient with neurologic disorders who are incapable of following directions - diagnosed Osteoporosis or Osteomalacia - Metabolic disorders which may impair bone formation - 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 or neuromuscular disease.

Related Information


public contact
Name Takahito Nakai
Address 11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan Japan 105-0011
Telephone 03-6402-6610
Affiliation Zimmer Biomet G. K. Clinical Affairs
scientific contact
Name Yukihide Minoda
Address 1-5-7 Asahimachi, Abeno-ku, Osaka, Japan Japan
Telephone 03-6402-6610
Affiliation Osaka City University Orthopaedic Surgery