Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: KneeAlign 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02695329

ORTHO.CR.GK53

Details and patient eligibility

About

Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments

Full description

Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
• Subjects willing to return for follow-up evaluations

Exclusion criteria

• Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
• Severe OA deformation (FTA: >185 degrees or <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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Vanguard with KneeAlign 2

Active Comparator group

Description:

Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.

Treatment:

Device: KneeAlign 2

Vanguard without KneeAlign 2

No Intervention group

Description:

Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.