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

Not Applicable

• Conditions: Knee Joint Diseases

• Registration Number: JPRN-UMIN000021279
• Lead Sponsor: Zimmer Biomet G. K.

Brief Summary

There were no complications reported. The absolute differences of the femoral prosthesis, tibial prosthesis, and hip-knee-ankle angle from a neutral mechanical axis were less in the navigation group compared with those in the conventional group. Alignment outliers of the tibial prosthesis and hip-knee-ankle angle were less in the navigation group (9% and 27%, respectively) compared with those in the conventional group (31% and 49%; p = 0.01 and p =0.04, respectively).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-02
• Study Completion: 2018-03-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified