Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Zimmer Biomet logo

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

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.

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems