N/A
Completed N=100
Vanguard TKA With KneeAlign 2 and Without KneeAlign 2
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT02695329 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia — 41; 31; 4; 14 Participants
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
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 | — |
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.
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. Informational only — not medical advice.