N/A N=100 Randomized Single-blind Supportive Care

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT02695329 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia — 41; 31; 4; 14 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: KneeAlign 2 (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Zimmer Biomet
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia	41; 31; 4; 14	—
SECONDARY Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold	26; 27; 19; 18	—
SECONDARY Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold	35; 28; 10; 17	—
SECONDARY Number of Participants With Adverse Events and/or Adverse Device Effects	1; 0	—

Summary

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

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02695329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.