Table 1

Patient treatment allocation and follow-up

Description
Allocation93 were enrolled
75 received intervention
18 did not receive intervention

  • 2 denied insurance coverage

  • 8 changed their minds

  • 3 were no longer surgical candidates at time of surgery

  • 5 were treated off protocol

2 y73 were evaluated (97.1% follow-up)

  • 2 secondary surgical interventions (included in primary composite endpoint, excluded from secondary analyses)

2 missed visits (excluded from analysis)
5 y56 were evaluated (74.7% follow-up)

  • 5 secondary surgical interventions (included in primary composite endpoint, excluded from secondary analyses)

19 missed visits (excluded from analysis)

  • 1 death

  • 18 were lost to follow-up