NCT02695329

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Completed NA Results posted Last updated 12 February 2020

What this trial tests

NA trial testing KneeAlign 2 in Osteoarthritis, Knee in 100 participants. Completed in 26 October 2018.

Timeline

24 May 2016

Primary endpoint
3 October 2018

26 October 2018

Quick facts

Lead sponsor	Zimmer Biomet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	100
Start date	24 May 2016
Primary completion	3 October 2018
Estimated completion	26 October 2018
Sites	1 location across Japan

Drugs / interventions tested

• KneeAlign 2

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Zimmer Biomet — full company profile →

Who can join

20 and older, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia Primary · Postoperative 6 months

Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.

Group	Value	95% CI
Vanguard With KneeAlign 2	41
Vanguard Without KneeAlign 2	31
Vanguard With KneeAlign 2	4
Vanguard Without KneeAlign 2	14

Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold Secondary · Postoperative 6 months

Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)

Group	Value	95% CI
Vanguard With KneeAlign 2	26
Vanguard Without KneeAlign 2	27
Vanguard With KneeAlign 2	19
Vanguard Without KneeAlign 2	18

Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold Secondary · Postoperative 6 months

Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)

Group	Value	95% CI
Vanguard With KneeAlign 2	35
Vanguard Without KneeAlign 2	28
Vanguard With KneeAlign 2	10
Vanguard Without KneeAlign 2	17

Number of Participants With Adverse Events and/or Adverse Device Effects Secondary · Intra-operative and Post-operative 6 months

Number of participants, who experience adverse events and/or adverse device effects

Group	Value	95% CI
Vanguard With KneeAlign 2	1
Vanguard Without KneeAlign 2	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From surgery to 6 month visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vanguard With KneeAlign 2

Serious: 0/50 (0%)

Deaths: 0/50

Vanguard Without KneeAlign 2

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (1 terms — click to expand)

Reaction	System	Vanguard With KneeAlign 2	Vanguard Without KneeAlign 2
Infection	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT02695329 adverse events section.

Sponsor's own 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.