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 |
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Health condition(s) or Problem(s) studied | Knee Joint Diseases |
Date of first enrollment | 2016/05/17 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Vanguard with KneeAlign 2 as investigational group. Vanguard with conventional instrumentation and without KneeAlign 2 as control group. |
Outcome(s)
Primary Outcome | Proportion of subjects that have alignment within 2 degrees from neutral on tibia at postoperative 6 months. |
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Secondary Outcome | Surgery 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 minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male 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
Primary Sponsor | Zimmer Biomet G. K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Zimmer Biomet G. K. |
Secondary ID(s) |
Contact
public contact | |
Name | Takahito Nakai |
Address | 11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan Japan 105-0011 |
Telephone | 03-6402-6610 |
takahito.nakai@zimmerbiomet.com | |
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 |
takahito.nakai@zimmerbiomet.com | |
Affiliation | Osaka City University Orthopaedic Surgery |